Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stent: an animal study comparison of wireless and over-the-wire techniques

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Nevertheless, lack of standardization and lumen-apposing metal stent (LAMS) misdeployment are limiting its spread. The aim was to compare the wireless endoscopic simplified technique (WEST) and the direct technique over a guided-wire (DTOG) and to evaluate patency and maximal anastomotic tensile strength (MATS) after LAMS-in-LAMS salvage therapy. A prospective animal study was performed comparing DTOG and WEST techniques. After performing an EUS-GE, LAMS-in-LAMS was performed to treat involuntary or voluntary LAMS misdeployment. The animals were followed during 12 weeks. Primary endpoints included technical success, safety and easiness of the EUS-GE, while secondary endpoints included patency and MATS of the anastomosis. 11 EUS-GE were performed in 10 living pigs. The WEST had a high technical success (100% vs 60%; p = 0.180), less voluntary misdeployment (33.3% vs 100%, p = 0.060), significantly high easiness score (7/10 vs 1/10; p < 0.01) and high technical outcomes compared to DTOG. Concerning LAMS-in-LAMS, technical success was 81.8%. At week 10 LAMS were removed and at week 12, the anastomosis diameter reduced by an average of 1.85 mm [range 0-9.5 mm]. The mean MATS was 27.46 ± 5.07 N. WEST resulted in higher technical success as compared to DTOG to create EUS-GE. In case of LAMS misdeployment, the LAMS-in-LAMS proofed to be a reliable rescue therapy with a good anastomotic patency and tensile strength. Health sciences/Gastroenterology Health sciences/Gastroenterology/Gastrointestinal models Health sciences/Gastroenterology/Oesophagogastroscopy EUS-guided gastroenterostomy lumen-apposing metal stent LAMS misdeployment animal study tensile strength Figures Figure 1 Figure 2 Figure 3 INTRODUCTION EUS-guided gastroenterostomy (EUS-GE) has become one of the treatment options of gastric outlet obstruction (GOO). With a technical success rate of 90–95% [ 1 , 2 ] and a high medium-term patency [ 3 , 4 ], EUS-GE has supplanted duodenal stenting in the management of GOO patients unfit for surgery [ 5 , 6 ]. Moreover, compared with surgical gastroenterostomy (SGE), EUS-GE has shown equivalent technical and clinical success rates with fewer complications [ 7 – 10 ]. In addition, EUS-GE allows rapid restauration of oral intake. In expert hands, EUS-GE is now proposed as the first line treatment for the management of malignant or benign GOO in non-operable patients [ 11 ].The main barriers to the widespread adoption of EUS-GE are the lack of standardization of the technique [ 12 ] and the risk of misdeployment of the lumen-apposing metal stent (LAMS) [ 13 , 14 ]. Despite the availability in the literature of a few tips and tricks to anticipate LAMS misdeployment [ 15 , 16 ], the management of this complication requires a high level of endoscopic expertise. Moreover, in case of failure of endoscopic salvage therapy, surgical management is proposed for patients often initially deemed unsuitable for surgery. Since the first clinical case-report of EUS-GE in 2015 [ 17 ], numerous variants of the EUS-GE technique have been described [ 18 ]. Distention of the target intestinal limb is no longer open to debate and is recommended prior to performing EUS-GE [ 11 , 19 ]. To increase the visibility of the target limb, an oro-intestinal drain [ 20 ], a nasojejunal drain [ 21 ] or a double balloon occluded catheter [ 22 ] can be used. Concerning the creation of the anastomosis with the LAMS, recent data suggest that the wireless endoscopic simplified technique (WEST) is preferrable over the direct technique over a guidewire (DTOG) [ 19 , 23 ]. There are little data in the literature comparing these two EUS-GE techniques [ 23 , 24 ] and standardization of the EUS-GE technique is still open to debate. LAMS misdeployment is the most feared adverse events (AE) of the technique, with a risk reaching up to 10% in the literature [ 25 – 27 ]. Four types of LAMS misdeployment are described by the international EUS-GE study group [ 25 ]. Types I and II misdeployment are the most common. Type I misdeployment represents intraperitoneal deployment of the distal flange without enterotomy. In this case, endoscopic closure of the gastric orifice and redo-EUS-GE is advised [ 25 , 28 ]. Type II misdeployment also represents intraperitoneal deployment of the distal flange with enterotomy. In case of type II misdeployment, natural orifice transluminal endoscopic surgery (NOTES) [ 29 ] or the stent-in-stent technique [ 30 , 31 ] seem to be better options [ 25 ]. The use of NOTES may be appealing but requires a high level of endoscopic expertise. The stent-in-stent technique or LAMS-in-LAMS requires less expertise but there is few data on the outcome of the anastomosis saved by this technique [ 32 ]. In-depth characterisation of the mechanical properties of soft tissues is important to help predict how they will behave during and after the creation of an anastomosis [ 33 ]. The concept is being explored in digestive surgery to better understand the behaviour of digestive anastomoses and the risk of anastomotic strictures or leaks. The burst pressure of the anastomosis is one of the physical parameters to be tested [ 34 , 35 ]. It is used to assess resistance to intraluminal deformation. The tensile strength of the anastomosis is another measurable parameter, enabling the rupture point of the anastomosis to be assessed [ 36 , 37 ]. The aim of this prospective animal study was to compare the outcomes of the DTOG and WEST technique in EUS-GE and to evaluate the endoscopic salvage therapy with LAMS-in-LAMS in case of misdeployment type II. METHODS A 12-week prospective animal study was conducted between June 2022 and April 2023 at an academic animal research facility (Centre for surgery and transplantation research, CHEX, Brussels, Belgium). The study was approved by the university ethical committee (Ethics commission for animal experimentation Health sciences sector, Catholic University of Louvain, Brussels, Belgium) for animal studies (ref: 2021/UCL/MD/072). All applicable institutional and national guidelines for the care and use of animals were followed under approval of the Institutional Animal Care and Use Committee (IACUC). We declare that all methods, treatments and euthanasia followed the recommendations for animal care in accordance with the American veterinary Medical association. All pigs (Sus scrofa domesticus) were 3 months old females with normal health from the Rattlerow Seghers NV breeding company (Lokeren, Belgium). All pigs arrived at the university animal facility 7 days before the procedures. The study was conducted in accordance with the ARRIVE guidelines [ 38 ]. EUS-GE anastomosis Each animal underwent pre-procedural sedation by an intramuscular injection of hypnotic (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg). It was then installed in the supine position on the operating table. A peripheral venous line was placed in an ear vein. Next endotracheal intubation was performed and gas anaesthesia was administered (Isofurane 3% for induction and 1.5% for maintenance). An injection of intravenous analgesic (buprenorphine 0.005–0.01 mg/kg) was given to ensure the animal’s comfort during the procedure and to manage post-procedural pain. All pigs received IV antibiotics (Cefazoline 2g) prior to the procedure until three days after. This anaesthesia protocol has been accepted by the local ethics committee and follows the recommendations of practice for the anaesthesia of large animals in laboratory. All EUS-GE were performed by an experienced endoscopist under fluoroscopic control. First, an oro-intestinal drain (7Fr nasal biliary drain, Cook Medical, Dublin, Ireland) was inserted into the target intestinal limb using a colonoscope or a double channel gastroscope (CF-H180 or GIF-2TH180 Olympus, Tokyo, Japan) to instil a mixture of saline with methylene blue and contrast medium. Then a therapeutic EUS endoscope (GF-UCT160, Olympus, Tokyo, Japan) was inserted into the stomach to perform the EUS-GE procedure. Regarding the WEST technique, the EUS-GE was created using the freehand insertion of the electrocautery-enhanced LAMS (Hot Spaxus 16*20 mm, Taewoong Medical, Seoul, Korea) using electrosurgical current (electrosurgical unit VIO 300 S, ERBE, Tübingen, Germany) in pure cut mode (effect 4, 120W) between the gastric lumen and the target intestinal limb (Fig. 1 a). The proximal flange of the LAMS was deployed and a guidewire (Jagwire 0.035 inch, Boston Scientific, MA, USA) was advanced into the jejunal limb. The distal flange was deployed under endoscopic and fluoroscopic view. Concerning the DTOG technique, the dilated target intestinal limb was located and punctured (Fig. 1 b) using a 19 G needle (19G EZ Shot 3, Olympus, Tokyo, Japan or a 19G Expect Slimline, Boston Scientific, MA, USA). A guidewire was inserted through the needle into the jejunal lumen under fluoroscopic control. The puncture needle was removed and the electrocautery-enhanced LAMS catheter was advanced over the guidewire into the jejunal limb in pure cut mode (effect 4, 120W). Finally, the LAMS was deployed between the jejunal and gastric lumen (Fig. 1 c). The time of the procedure, the number of attempts, the need of salvage therapy and procedure-related AEs were registered. A questionnaire and a visual analogue scale assessing the ease of the procedure were completed by the endoscopist and the assistant at the end of the procedure. The easiness of the procedure was also assessed using a visual analogue scale (VAS): the higher the score the easier the procedure. In case of involuntary misdeployment type I, a second attempt was performed using the same technique. In case of involuntary misdeployment type II, a salvage therapy using the LAMS-in-LAMS technique was performed. The misdepolyed LAMS was dilated up to 15mm using a dilatation balloon catheter (CRE-Wireguided balloon dilatation catheter, Boston Scientific, MA, USA). A second co-axial LAMS was placed over the guide wire through the misdeployed LAMS(Fig. 2 a). The proximal flange was deployed into the intestinal lumen and the jejunal limb was pulled backwards against the misdepolyed LAMS. Then, the co-axial LAMS was correctly deployed between the jejunal and gastric lumen through the misdepolyed LAMS (Fig. 2 b and 2 c). In case of initial success of EUS-GE, a voluntary misdeployment type II was created (Fig. 3 a and 3 b) by pulling the LAMS from the jejunal limb into the peritoneum using a rat tooth forceps (Rat tooth/alligator grasping forceps, Boston Scientific, MA USA). A salvage therapy using the LAMS-in-LAMS technique was then applied. After the procedure All animals received IV antibiotics (Cefazoline 2g ) for three days. A pain scale for large animal was used to assess animal welfare [ 39 ]. A pain killer was administrated in function of the result of the pain scale results. After the procedure, the pigs had unlimited access to water. Feeding was resumed 24 hours after the procedure if there were no clinical signs of suffering. Follow up The pigs were on a conventional cereal meal diet twice daily. Oral intake, animal wellbeing and behaviour were monitored daily per animal facility standard procedures and listed in a diary. The animals’ weight was recorded once a week. A follow-up upper endoscopy was performed once a week under sedation (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg) to inspect the patency of the LAMS. Endoscopic removal of all LAMS was performed at week 10. Removed LAMS were examined for tissue interposition. Euthanasia and final examination At week 12, a final upper endoscopy was performed to inspect the patency of the gastroenterostomy without LAMS. Next the animals were euthanized (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg associated with injection of T-61) and at necropsy, gross examination of the peritoneal cavity was performed to search for signs of inflammation, infection or abscesses. Each anastomosis was surgically resected and examined macroscopically. The diameter of each anastomosis was recorded using a ring size measure rod. Then the resected anastomosis segment was individually mounted to measure the anastomotic tensile strength and breaking point ( supplementary materials : Fig. 1 s). The maximal anastomotic tensile strength (MATS) corresponded to the complete rupture of the anastomosis. The progressive lengthening of the anastomosis by the applied traction force was also measured. Similarly, tensile strength and breaking point of a normal jejunal segment was studied. Study endpoints Primary endpoints of the prospective animal study were the comparison of the technical outcomes and easiness of the WEST and DTOG EUS-GE techniques. Secondary endpoints were technical success of salvage therapy using the LAMS-in-LAMS technique, patency of the anastomosis and anastomotic tensile strength analysis. Statistical analysis Categorical variables were compared using χ² or Fisher-exact tests. Normal and non-normally distributed variables were presented as mean (SD) and median (range). They were analysed using the Student t-test, Mann-Whitney U-test or Kruskal-Wallis test accordingly. A two-sided p-value < 0.05 was considered statistically significant. An internal validation of the VAS of the easiness of the procedure was assessed using Efron’s enhanced bootstrap method [ 40 ]. This method was applied to confirm the agreement between the qualitative response of the questionnaire and the score on the VAS of the easiness of the procedure. Statistical analyses were carried out using TIBO Statistica v13.3 software (University of Montpellier, research laboratory MRE-TRIS France). RESULTS A total of 10 pigs were divided in two groups : 5 pigs randomly underwent the DTOG and 5 pigs the WEST technique. Comparison of the outcomes of WEST and DTOG technique 11 EUS-GE were performed with 5 in the DTOG group and 6 in the WEST group. A flow chart (Fig. 4 ) resumes the follow-up of the experiment. The mean time required to insert the oro-intestinal drain was 18.5 min ± 3.6 min and the mean number of attempts was 1.4. The mean distention diameter of the target intestinal limb at the start of the EUS-GE procedure was 21.2 mm in the WEST group and 20.8 mm in the DTOG group without significant difference (p = 0.84). Technical success to create the EUS-GE was higher in the WEST group than the DTOG group, which turned out to be more difficult to perform (100% vs 60% respectively, p = 0.18). The rate of involuntary misdeployment was lower in the WEST group than in the DTOG group (33.3% vs 100% respectively, p = 0.06). In the DTOG group, two pigs needed to be euthanized at the end of the procedure due to failure of endoscopic salvage therapy after spontaneous misdeployment. The mean procedure time was significantly lower in the WEST group than in the DTOG group (17 ± 8 min vs 69 ± 18 min respectively, p = 0.002). The number of attempts was significantly lower in the WEST group than in the DTOG group ( 1.3 vs 6.7 respectively, p = 0.003). Results are listed in Table 1 . The mean VAS score for technical easiness (Table 1 ) was significantly higher in the WEST group than the DTOG group (7/10 vs 1/10 respectively, p < 0.001). The Efron’s enhanced boostrap method confirmed the agreement between the qualitative responses of the questionnaire and the quantitative score of the VAS ( supplementary material : Fig. 2 s). Table 1 Technical outcomes of both EUS-GE techniques (WEST = Wireless endoscopic simplified technique ; DTOG = Directed techniques over the guidewire ; EUS-GE = EUS guided gastroenterostomy ; VAS = Visual analogue scale) total WEST technique DTOG technique Probability Technical outcomes of oro-intestinal catheter - Mean time (min) - Mean number of attempts (n) - Mean distention jejunal limb(mm) 11 18.5 ± 3.6 1.4 21 ± 3.1 6 18.8 ± 4.5 1.6 21.2 ± 3.7 5 18 ± 2.4 1 20.8 ± 2.4 NA p = 0.78 p = 0.02 p = 0.84 Technical success of EUS-GE (n ; %) 9 (81.8) 6 (100) 3 (60%) p = 0.18 Involuntary LAMS misdeployment 7 2 (33.3%) 5 (100%) p = 0.06 Technical outcomes of EUS-GE - Mean number of attempts (n) - Mean time (min) 4 34.4 ± 23.4 1.3 17 ± 7.7 6.7 69.3 ± 17.8 p = 0.003 p = 0.002 Evaluation of easiness of the procedure - Mean VAS 4/10 7/10 1/10 P < 0.001 Endoscopic rescue therapy with LAMS-in-LAMS A total of 9 LAMS-in-LAMS were performed in 8 living pigs. Technical success of the LAMS-in-LAMS was 81.8%. A spontaneous distal migration of the two co-axial LAMS without clinical consequence was reported in one pig one week after the initial procedure (11.1%). Patency of the anastomosis after LAMS-in-LAMS Follow-up upper endoscopy was performed every week during 10 weeks in the 8 remaining pigs, confirming the correct position and patency of the LAMS. No occlusion of the LAMS due to food impaction or tissue overgrowth was observed. All the LAMS (with a diameter of 16 mm) were endoscopically removed at week 10 using a rat tooth forceps. In all pigs, the co-axial LAMS were impacted in each other without tissue interposition ( supplementary materials : Fig. 3 s ). Endoscopic control prior to the necropsy confirmed patency of the gastroenterostomy in all pigs (8/8). Moreover the gastroenterostomy was accessible with the endoscope in 7/8 pigs (87.5%). During the necropsy, signs of peritoneal inflammation with micro-abscesses were found in one pig (1/8, 12.5%). After the necropsy, the mean diameter of the anastomosis was measured at 13.3 ± 2 mm with a mean reduction of the diameter of 1.85 mm [0 ; 9.5]. Histological examination of one anastomosis confirmed fibrotic fusion of the gastric and jejunal tissues with formation of scar tissue ( supplementary material : Fig. 4 s). Anastomotic physical resistance analyse Physical resistance of the anastomosis was studied in 7 pigs. Among them, one anastomosis was used to test compatibility with a tensile strength testing machine without success. Therefore, the point of rupture force was analysed in 6 anastomoses and tissue elasticity was analysed in 5 by applying progressive gradual traction force. The mean MATS was 27.46 ± 5.07 N and the mean lengthening of the anastomosis was 7.76 ± 1.75 mm until rupture. During the tensile strength test, all the models ruptured at the level of the anastomosis. Physical resistance of the jejunal tissue was studied in 6 pigs. The mean maximal jejunal tensile strength was 13.48 ± 2.72 N. The mean lengthening of the jejunal tissue was 87.4 ± 38.8 mm until rupture. All these results were reported in Table 2 . Table 2 Results of physical resistance of anastomotic and jejunal tissue (MATS = maximal anastomotic tensile strength ; MJTS = maximal jejunal tensile strength; N = Newton) Pig 4 Pig 6 Pig 7 Pig 8 Pig 9 Pig 10 Mean Physical resistance of the anastomosis: - MATS (N) - Lengthening of anastomosis (mm) 36.29 NA 28.44 5.5 30.4 7 20.4 6.4 27.95 11.6 21.58 8.3 27.46 ± 5.07 7.76 ± 1.75 Physical resistance of the jejunal segment: - MJTS (N) - Lengthening of jejunal tissue (mm) 14.7 52 18.14 124 15.2 77 11.28 130 7.36 49 13.73 57 13.48 ± 2.72 87.4 ± 38.8 DISCUSSION We conducted a longitudinal porcine study to compare the outcomes of the WEST and DTOG techniques to perform EUS-GE and to evaluate the outcomes of endoscopic rescue therapy using the LAMS-in-LAMS technique. A comparison of different classical outcomes was performed. Technical success was higher in the WEST group with a shorter procedure time needing less attempts as compared to the DTOG group. Moreover, the risk of involuntary LAMS misdeployment was lower in the WEST group than in the DTOG group, illustrating that the DTOG technique using a guidewire is more difficult than the free-hand WEST technique. These results confirm the superiority of the WEST technique over the DTOG technique for the creation of EUS-GE, as recently shown in a clinical retrospective human study [ 23 ]. The WEST technique appears easier than the DTOG technique to perform EUS-GE as shown by the higher VAS score. Magahis et al. previously showed that the majority (71.4%) of EUS experts performing EUS-GE prefer the WEST technique because of its better technical feasibility and outcome [ 19 ]. Therefore, the WEST technique should be advocated as the standardized method of choice to perform EUS-GE, as shown both in animal and clinical studies. Since the risk of LAMS misdeployment is an important issue hampering the wide spread use of the EUS-GE technique, we also studied the effectiveness of salvage techniques and to evaluate the patency of the anastomosis after the LAMS-in-LAMS rescue technique. This stent-in-stent technique is suggested for the treatment of misdeployment type II [ 25 ]. However, with the stent-in-stent technique for type II misdeployment, the jejunal wall is captured between the flares of the co-axial LAMS, possibly reducing the chance of a correct fibrotic fusion of the gastric and jejunal wall. There are currently no animal or human studies on the outcomes and patency of EUS-GE after rescue therapy using this technique. Our survival porcine study clearly demonstrated the feasibility, effectiveness and safety of the LAMS-in-LAMS technique as a rescue therapy in case of stent misdeployment type II with a technical success 81.8%. The high technical rescue success rate was most likely related to the introduction of a guide wire to secure the tract before the voluntary misdeployment. The guide wire seems therefore mandatory in the event of misdeployment type II in order to maintain access through the jejunal orifice and is best inserted after the jejunal flange has been deployed. Earlier insertion of the guidewire may increase the risk of pushing away the target limb, as seen in the DTOG technique. This explains the higher rate of involuntary LAMS misdeployment in the DTOG group compared to the WEST group (100% vs 33%, p = 0.06). This idea was also reported by some experts questioned in the study of Magahis et al.[ 19 ]. Therefore, in case of doubt or difficult LAMS release, it is advocated to keep a guide wire ready to be introduced into the jejunal lumen once the jejunal flange is opened, before completion of the procedure. The guide wire can help to rescue the procedure in case of LAMS migration out of the jejunal lumen into the peritoneal cavity while applying traction onto the stent before the release of the gastric flange. In addition, the patency of the gastroenterostomy was excellent even after LAMS-in-LAMS technique during 10 weeks in all pigs, indicating that the jejunal tissue interposition between the two co-axial stents does not seem to mortgage the technical and clinical success of the rescued EUS-GE. However, after the removal of the LAMS, a mean reduction in the anastomotic diameter of 1.85 mm was noted. This progressive reduction of the diameter was also reported in 2 out 3 animals in the porcine study by Gonzalez et al. [ 41 ]. The ideal LAMS dwelling time resulting in a permanent and functional EUS-GE anastomosis is currently unknown. However, in the EUS-directed trans-gastric ERCP (EDGE) procedure, a comparable technique to create a gastrogastrostomy or jejunogastrostomy in Roux-en-Y gastric bypass, the only factor identified for persistent fistula is a long mean LAMS dwelling time (> 40 days in situ) [ 42 ]. In our study, the LAMS was kept in place for 70 days. It appears that the LAMS dwelling time is not the only factor explaining the progressive reduction of the anastomotic diameter after removal of the LAMS. The reduction of the diameter is part of the healing processes of a non-surgical anastomosis, that is activated after the removal of the LAMS. However, in view of the expansion of EUS-GE indications to treat benign gastric outlet obstruction, long term patency after removal of the LAMS is warranted. This information is of the utmost importance, and further studies should focus on this topic. The current study also focussed on the LAMS-in-LAMS rescue technique with biomechanical analysis of tensile and breaking force of the anastomosis created with the risk of tissue interposition between the two co-axial stents. It is the first study to introduce the concept of anastomotic physical resistance in EUS-GE. The mean MATS was 27,46 ± 5.07N before rupture of the anastomosis. The tensile strength appeared to be better at the level of the fibrotic anastomosis as compared to normal jejunal tissue. In the literature, the mean maximal tensile strength in surgical small bowel anastomosis was 13.5 ± 3.76 N [ 36 , 37 ]. The resistance of the EUS-GE anastomosis, even after rescue therapy, was therefore at least equivalent to that of a surgical intestinal anastomosis in terms of biomechanical properties, despite the jejunal wall interposition between the two co-axial stents. The results of our study are encouraging, showing that the EUS-GE anastomosis is of reliable biomechanical quality even after the LAMS-in-LAMS rescue technique. However, comparisons must be made with caution, as the results in the literature relate only to small intestinal anastomosis, whereas the results of our study relate to gastrointestinal anastomosis. In addition, the tensile strength measurements should be performed in a standardized uniform way. CONCLUSION The WEST technique appears to be simpler and safer than the DTOG technique to perform EUS-GE in this porcine animal model. However, in case of misdeployment type II, LAMS-in-LAMS technique over the guide wire was shown technically successful and resulted in a good patency of the anastomosis. The biomechanical results of MATS after rescue therapy even outclassed the MATS of surgical small bowel anastomosis in the literature. The current study added valuable information to the knowledge of the recently developed EUS-GE technique and how to overcome failures using the stent-in-stent rescue method. Further animal studies are needed to compare MATS of surgical and EUS-guided anastomoses. Declarations DATA AVAILABILITY The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. ACKNOWLEDGEMENTS European Society of Gastrointestinal Endoscopy (ESGE) grant 2021 Prion Medical (Belgium) and Taewoong Medical (Korea) for the free provision of HotSpaxus 16*20 mm LAMS. ERBE (Belgium) for the free provision of the electrosurgical unit. Olympus (Belgium) for the free provision of the EUS endoscope and ultrasound machine. Author’s contributions TG MOREELS, M. BARTHET, JM GONZALEZ and L MONINO concepted the study and analyzed the results. PH DEPREZ, R. EVRARD, E.BONACORSI helped to develop the concept for the soft tissue study. TG MOREELS and L MONINO performed therapeutic endoscopy. P BALDINanalyzed the histologic samples. L MONINO wrote the first draft of the manuscript. TG MOREELS adapted the first draft of the manuscript. All authors provided critical revision and correction of the manuscript and approved the final draft Ethical Approval : The study was approved by the university ethical committee for animal studies (2021/UCL/MD/072). Conflicts of interest : Laurent MONINO is a consultant for Fujifilm, COOK Medical, Boston Scientific, Prion Medical, AlphaSigma and Braun Medical and received speaker’s fees from Olympus Belgium and Olympus Europe. Jean-Michel GONZALEZ and Marc BARTHET are consultants for Boston Scientific. Pierre H. DEPREZ is a consultant for Boston Scientific and Olympus Europe. Tom G. MOREELS received speaker’s fees from Olympus Belgium and Olympus Europe. References Iqbal, U. et al. 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Nasojejunal tube-assisted endoscopic ultrasound-guided gastrojejunostomy for the management of gastric outlet obstruction is safe and effective. DEN Open. 3 , e210 (2023). Itoi, T. et al. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut 65 , 193–195 (2016). Monino, L. et al. Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stents: A retrospective multicentric comparison of wireless and over-the-wire techniques. Endoscopy 55 , 991–999 (2022). Chen, Y. I. et al. EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. Gastrointest. Endosc . 87 , 1215–1221 (2018). Ghandour, B. et al. Classification, outcomes, and management of misdeployed stents during EUS-guided gastroenterostomy. Gastrointest. Endosc . 95 , 80–89 (2022). Giri, S. et al. Adverse events with endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction—A systematic review and meta-analysis. United Eur. Gastroenterol. J. 12 , 879–890 (2024). Fabbri, C. et al. Hybrid gastroenterostomy using a lumen-apposing metal stent: a case report focusing on misdeployment and systematic review of the current literature. World J. Emerg. Surg. 17 , 6 (2022). Fuentes-Valenzuela, E. et al. Temporary EUS-guided gastrojejunostomy for gastric outlet obstruction caused by severe acute pancreatitis (with videos). Endosc Ultrasound . 12 , 164 (2023). Rizzo, G. E. M. et al. Complete intraperitoneal maldeployment of a lumen-apposing metal stent during EUS-guided gastroenteroanastomosis for malignant gastric outlet obstruction: rescue retrieval with peritoneoscopy through natural orifice transluminal endoscopic surgery. VideoGIE 8 , 310 (2023). Pandey, S. et al. Dislodged lumen-apposing metal stent (LAMS) in EUS-guided gastrojejunostomy salvaged by LAMS-in-LAMS technique. Gastrointest. Endosc . 97 , 799–800 (2023). Sondhi, A. R. & Law, R. Intraperitoneal salvage of an EUS-guided gastroenterostomy using a nested lumen-apposing metal stent. VideoGIE 5 , 415–417 (2020). Monino, L. et al. Alternative endoscopic salvage therapies using lumen-apposing metal stents for stent misdeployment during endoscopic ultrasound-directed transgastric intervention. Endoscopy 56 , E892–E893 (2024). Sif Julie, F. et al. Dynamic viscoelastic properties of porcine gastric tissue: Effects of loading frequency, region and direction. J. Biomech. 143 , 111302 (2022). Giusto, G. et al. Comparison of two different barbed suture materials for end-to-end jejuno-jejunal anastomosis in pigs. Acta Vet. Scand. 61 , 3 (2019). Tomori, K. et al. Comparison of Strength of Anastomosis Between Four Different Techniques for Colorectal Surgery. Anticancer Res. 40 , 1891–1896 (2020). Nygaard, M. S. et al. Remote ischemic postconditioning has a detrimental effect and remote ischemic preconditioning seems to have no effect on small intestinal anastomotic strength. Scand. J. Gastroenterol. 57 , 768–774 (2022). Zheng, M. Y. et al. Short cycles of remote ischemic preconditioning had no effect on tensile strength in small intestinal anastomoses: an experimental animal study. J. Gastrointest. Surg. 28 , 1777–1782 (2024). du Sert, N. P. et al. The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research. PLoS Biol ; 18. Epub ahead of print 1 July 2020. 10.1371/JOURNAL.PBIO.3000410 Stasiak, K. L. et al. Species-specific assessment of pain in laboratory animals. Contemp. Top. Lab. Anim. Sci. 42 , 13–20 (2003). Henderson, A. R. The bootstrap: a technique for data-driven statistics. Using computer-intensive analyses to explore experimental data. Clin. Chim. Acta . 359 , 1–26 (2005). Gonzalez, J. M. et al. First fully endoscopic metabolic procedure with NOTES gastrojejunostomy, controlled bypass length and duodenal exclusion: a 9-month porcine study. Sci. Rep. 12 , 21 (2022). Ghandour, B. et al. Factors predictive of persistent fistulas in EUS-directed transgastric ERCP: a multicenter matched case-control study. Gastrointest. Endosc . 97 , 260–267 (2023). Additional Declarations Competing interest reported. Laurent MONINO is a consultant for Fujifilm, COOK Medical, Boston Scientific, Prion Medical, AlphaSigma and Braun Medical and received speaker’s fees from Olympus Belgium and Olympus Europe. Jean-Michel GONZALEZ and Marc BARTHET are consultants for Boston Scientific. Pierre H. DEPREZ is a consultant for Boston Scientific and Olympus Europe. Tom G. MOREELS received speaker’s fees from Olympus Belgium and Olympus Europe. The other authors declare no conflict of interests. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6287871","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":458149818,"identity":"ad9776af-dab2-4f71-97d9-afb72858b124","order_by":0,"name":"Laurent MONINO","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+klEQVRIiWNgGAWjYJCCA0AsA2XbJICphAIGfkJaeCDMhLQEBjYQbcAg2UDAJpiWwxAtDHi06Lb3HjxcUMHAwz8j9+Hjwh/n8/jluxM/PDBgkDDHocfszLmEwzPOMPBI3Eg3Np6RcLtYso13swTQYRIyB3BouZFjcJi3DeiwG2ls0jwJtxM3HOPdANJSJ4HDYXAt8jfS2H/zJJwDadn8A2QLQS0GQFuYeRIOgLRsk8Cr5cwZg8M8ZyR4DM88Y5bmSUtOnNmWu80iwUACt5bjPcafeSps5OSOpzF+5rGxS+xnPrv55o8KG5xaoABTmoCGUTAKRsEoGAV4AQBVlFPh7t/4EQAAAABJRU5ErkJggg==","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":true,"prefix":"","firstName":"Laurent","middleName":"","lastName":"MONINO","suffix":""},{"id":458149819,"identity":"a489b4b0-2a87-45dc-8d9a-1c725fe96675","order_by":1,"name":"Jean-Michel GONZALEZ","email":"","orcid":"","institution":"Assistance Publique des Hôpitaux de Marseille","correspondingAuthor":false,"prefix":"","firstName":"Jean-Michel","middleName":"","lastName":"GONZALEZ","suffix":""},{"id":458149820,"identity":"7b60c306-c274-45ca-9b4d-bbe929ced4d8","order_by":2,"name":"Robin EVRARD","email":"","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":false,"prefix":"","firstName":"Robin","middleName":"","lastName":"EVRARD","suffix":""},{"id":458149821,"identity":"0bded1e3-0fdf-4912-940b-346a33a286d2","order_by":3,"name":"Eliano BONACORSI","email":"","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":false,"prefix":"","firstName":"Eliano","middleName":"","lastName":"BONACORSI","suffix":""},{"id":458149822,"identity":"ea525174-8d00-4d35-a029-1f6139f8c90b","order_by":4,"name":"Pamela BALDIN","email":"","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":false,"prefix":"","firstName":"Pamela","middleName":"","lastName":"BALDIN","suffix":""},{"id":458149823,"identity":"c36c6664-32e0-4460-869b-95ab11cc4bf4","order_by":5,"name":"Pierre H. DEPREZ","email":"","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":false,"prefix":"","firstName":"Pierre","middleName":"H.","lastName":"DEPREZ","suffix":""},{"id":458149824,"identity":"ea4c53fb-2bbf-4a10-8c11-ac917e4d618d","order_by":6,"name":"Marc BARTHET","email":"","orcid":"","institution":"Assistance Publique des Hôpitaux de Marseille","correspondingAuthor":false,"prefix":"","firstName":"Marc","middleName":"","lastName":"BARTHET","suffix":""},{"id":458149825,"identity":"ddc46c2c-d15a-430a-bde6-abcbff55af22","order_by":7,"name":"Tom G. MOREELS","email":"","orcid":"","institution":"Université catholique de Louvain, Cliniques universitaires Saint-Luc","correspondingAuthor":false,"prefix":"","firstName":"Tom","middleName":"G.","lastName":"MOREELS","suffix":""}],"badges":[],"createdAt":"2025-03-23 11:08:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6287871/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6287871/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41598-025-27688-1","type":"published","date":"2025-12-16T15:57:53+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":83199165,"identity":"fc33d98d-6542-456a-a944-24938aa40b30","added_by":"auto","created_at":"2025-05-21 06:07:16","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1052092,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFluoroscopic images of both EUS-GE techniques\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1a: \u003c/strong\u003eFree hand puncture of the target jejunal limb of the wireless endoscopy simplified technique (WEST)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1b: \u003c/strong\u003eNeedle puncture of the target jejunal limb of the direct technique over a guidewire (DTOG)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1c\u003c/strong\u003e: Deployment of the LAMS between the jejunal and the gastric lumen\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6287871/v1/eb5957b3d1c380587feb2808.png"},{"id":83199169,"identity":"635b288b-4a38-48b1-a0af-c2a9e21283a0","added_by":"auto","created_at":"2025-05-21 06:07:16","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1332322,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEndoscopic and fluoroscopic images of the LAMS-in-LAMS technique\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2a : \u003c/strong\u003eDeployment of the proximal flange of the co-axial LAMS through the misdeployed LAMS\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2b : \u003c/strong\u003eDeployment of the co-axial LAMS into the misdepolyed LAMS\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2c : \u003c/strong\u003eEndoscopic view of the jejunal limb after the LAMS-in-LAMS rescue technique\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6287871/v1/6dade4cf370a53ed22912a25.png"},{"id":83199162,"identity":"227a7fce-277b-47f4-ac97-adbe2547a29a","added_by":"auto","created_at":"2025-05-21 06:07:16","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1000513,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEndoscopic images of the creation of a voluntary misdeployment type II\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3a:\u003c/strong\u003e The proximal flange of the LAMS was caught with a rat tooth forceps\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3b:\u003c/strong\u003e The distal flange was pulled out into the peritoneum\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6287871/v1/3fc61c6ebe03a61a44a75216.png"},{"id":98813959,"identity":"7a1ac9ec-6223-4c25-8ab0-c9f0c8b0f77e","added_by":"auto","created_at":"2025-12-22 16:08:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4147573,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6287871/v1/02d5ce08-3305-40e1-8316-9b50675c2b55.pdf"},{"id":83201718,"identity":"abeca1c6-a2e0-4f30-a395-37b1866bb556","added_by":"auto","created_at":"2025-05-21 06:31:16","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":1745727,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementarymaterial.docx","url":"https://assets-eu.researchsquare.com/files/rs-6287871/v1/1b0ab82a933daa23685d6349.docx"}],"financialInterests":"Competing interest reported. Laurent MONINO is a consultant for Fujifilm, COOK Medical, Boston Scientific, Prion Medical, AlphaSigma and Braun Medical and received speaker’s fees from Olympus Belgium and Olympus Europe. Jean-Michel GONZALEZ and Marc BARTHET are consultants for Boston Scientific. Pierre H. DEPREZ is a consultant for Boston Scientific and Olympus Europe. Tom G. MOREELS received speaker’s fees from Olympus Belgium and Olympus Europe. \nThe other authors declare no conflict of interests.","formattedTitle":"Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stent: an animal study comparison of wireless and over-the-wire techniques","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003e EUS-guided gastroenterostomy (EUS-GE) has become one of the treatment options of gastric outlet obstruction (GOO). With a technical success rate of 90\u0026ndash;95% [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] and a high medium-term patency [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], EUS-GE has supplanted duodenal stenting in the management of GOO patients unfit for surgery [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Moreover, compared with surgical gastroenterostomy (SGE), EUS-GE has shown equivalent technical and clinical success rates with fewer complications [\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In addition, EUS-GE allows rapid restauration of oral intake. In expert hands, EUS-GE is now proposed as the first line treatment for the management of malignant or benign GOO in non-operable patients [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].The main barriers to the widespread adoption of EUS-GE are the lack of standardization of the technique [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] and the risk of misdeployment of the lumen-apposing metal stent (LAMS) [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Despite the availability in the literature of a few tips and tricks to anticipate LAMS misdeployment [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], the management of this complication requires a high level of endoscopic expertise. Moreover, in case of failure of endoscopic salvage therapy, surgical management is proposed for patients often initially deemed unsuitable for surgery.\u003c/p\u003e \u003cp\u003eSince the first clinical case-report of EUS-GE in 2015 [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], numerous variants of the EUS-GE technique have been described [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Distention of the target intestinal limb is no longer open to debate and is recommended prior to performing EUS-GE [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. To increase the visibility of the target limb, an oro-intestinal drain [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], a nasojejunal drain [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] or a double balloon occluded catheter [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] can be used. Concerning the creation of the anastomosis with the LAMS, recent data suggest that the wireless endoscopic simplified technique (WEST) is preferrable over the direct technique over a guidewire (DTOG) [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. There are little data in the literature comparing these two EUS-GE techniques [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] and standardization of the EUS-GE technique is still open to debate.\u003c/p\u003e \u003cp\u003eLAMS misdeployment is the most feared adverse events (AE) of the technique, with a risk reaching up to 10% in the literature [\u003cspan additionalcitationids=\"CR26\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Four types of LAMS misdeployment are described by the international EUS-GE study group [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Types I and II misdeployment are the most common. Type I misdeployment represents intraperitoneal deployment of the distal flange without enterotomy. In this case, endoscopic closure of the gastric orifice and redo-EUS-GE is advised [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Type II misdeployment also represents intraperitoneal deployment of the distal flange with enterotomy. In case of type II misdeployment, natural orifice transluminal endoscopic surgery (NOTES) [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e] or the stent-in-stent technique [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] seem to be better options [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. The use of NOTES may be appealing but requires a high level of endoscopic expertise. The stent-in-stent technique or LAMS-in-LAMS requires less expertise but there is few data on the outcome of the anastomosis saved by this technique [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In-depth characterisation of the mechanical properties of soft tissues is important to help predict how they will behave during and after the creation of an anastomosis [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. The concept is being explored in digestive surgery to better understand the behaviour of digestive anastomoses and the risk of anastomotic strictures or leaks. The burst pressure of the anastomosis is one of the physical parameters to be tested [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. It is used to assess resistance to intraluminal deformation. The tensile strength of the anastomosis is another measurable parameter, enabling the rupture point of the anastomosis to be assessed [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe aim of this prospective animal study was to compare the outcomes of the DTOG and WEST technique in EUS-GE and to evaluate the endoscopic salvage therapy with LAMS-in-LAMS in case of misdeployment type II.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eA 12-week prospective animal study was conducted between June 2022 and April 2023 at an academic animal research facility (Centre for surgery and transplantation research, CHEX, Brussels, Belgium). The study was approved by the university ethical committee (Ethics commission for animal experimentation Health sciences sector, Catholic University of Louvain, Brussels, Belgium) for animal studies (ref: 2021/UCL/MD/072). All applicable institutional and national guidelines for the care and use of animals were followed under approval of the Institutional Animal Care and Use Committee (IACUC). We declare that all methods, treatments and euthanasia followed the recommendations for animal care in accordance with the American veterinary Medical association. All pigs (Sus scrofa domesticus) were 3 months old females with normal health from the Rattlerow Seghers NV breeding company (Lokeren, Belgium). All pigs arrived at the university animal facility 7 days before the procedures. The study was conducted in accordance with the ARRIVE guidelines [\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eEUS-GE anastomosis\u003c/h2\u003e\n \u003cp\u003eEach animal underwent pre-procedural sedation by an intramuscular injection of hypnotic (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg). It was then installed in the supine position on the operating table. A peripheral venous line was placed in an ear vein. Next endotracheal intubation was performed and gas anaesthesia was administered (Isofurane 3% for induction and 1.5% for maintenance). An injection of intravenous analgesic (buprenorphine 0.005\u0026ndash;0.01 mg/kg) was given to ensure the animal\u0026rsquo;s comfort during the procedure and to manage post-procedural pain. All pigs received IV antibiotics (Cefazoline 2g) prior to the procedure until three days after. This anaesthesia protocol has been accepted by the local ethics committee and follows the recommendations of practice for the anaesthesia of large animals in laboratory. All EUS-GE were performed by an experienced endoscopist under fluoroscopic control. First, an oro-intestinal drain (7Fr nasal biliary drain, Cook Medical, Dublin, Ireland) was inserted into the target intestinal limb using a colonoscope or a double channel gastroscope (CF-H180 or GIF-2TH180 Olympus, Tokyo, Japan) to instil a mixture of saline with methylene blue and contrast medium. Then a therapeutic EUS endoscope (GF-UCT160, Olympus, Tokyo, Japan) was inserted into the stomach to perform the EUS-GE procedure.\u003c/p\u003e\n \u003cp\u003eRegarding the WEST technique, the EUS-GE was created using the freehand insertion of the electrocautery-enhanced LAMS (Hot Spaxus 16*20 mm, Taewoong Medical, Seoul, Korea) using electrosurgical current (electrosurgical unit VIO 300 S, ERBE, T\u0026uuml;bingen, Germany) in pure cut mode (effect 4, 120W) between the gastric lumen and the target intestinal limb (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003ea). The proximal flange of the LAMS was deployed and a guidewire (Jagwire 0.035 inch, Boston Scientific, MA, USA) was advanced into the jejunal limb. The distal flange was deployed under endoscopic and fluoroscopic view. Concerning the DTOG technique, the dilated target intestinal limb was located and punctured (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003eb) using a 19 G needle (19G EZ Shot 3, Olympus, Tokyo, Japan or a 19G Expect Slimline, Boston Scientific, MA, USA). A guidewire was inserted through the needle into the jejunal lumen under fluoroscopic control. The puncture needle was removed and the electrocautery-enhanced LAMS catheter was advanced over the guidewire into the jejunal limb in pure cut mode (effect 4, 120W). Finally, the LAMS was deployed between the jejunal and gastric lumen (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003ec). The time of the procedure, the number of attempts, the need of salvage therapy and procedure-related AEs were registered.\u003c/p\u003e\n \u003cp\u003eA questionnaire and a visual analogue scale assessing the ease of the procedure were completed by the endoscopist and the assistant at the end of the procedure. The easiness of the procedure was also assessed using a visual analogue scale (VAS): the higher the score the easier the procedure.\u003c/p\u003e\n \u003cp\u003eIn case of involuntary misdeployment type I, a second attempt was performed using the same technique. In case of involuntary misdeployment type II, a salvage therapy using the LAMS-in-LAMS technique was performed. The misdepolyed LAMS was dilated up to 15mm using a dilatation balloon catheter (CRE-Wireguided balloon dilatation catheter, Boston Scientific, MA, USA). A second co-axial LAMS was placed over the guide wire through the misdeployed LAMS(Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003ea). The proximal flange was deployed into the intestinal lumen and the jejunal limb was pulled backwards against the misdepolyed LAMS. Then, the co-axial LAMS was correctly deployed between the jejunal and gastric lumen through the misdepolyed LAMS (Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003eb and \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003ec). In case of initial success of EUS-GE, a voluntary misdeployment type II was created (Fig. \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003ea and \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003eb) by pulling the LAMS from the jejunal limb into the peritoneum using a rat tooth forceps (Rat tooth/alligator grasping forceps, Boston Scientific, MA USA). A salvage therapy using the LAMS-in-LAMS technique was then applied.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eAfter the procedure\u003c/h3\u003e\n\u003cp\u003eAll animals received IV antibiotics (Cefazoline 2g ) for three days. A pain scale for large animal was used to assess animal welfare [\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e]. A pain killer was administrated in function of the result of the pain scale results. After the procedure, the pigs had unlimited access to water. Feeding was resumed 24 hours after the procedure if there were no clinical signs of suffering.\u003c/p\u003e\n\u003ch3\u003eFollow up\u003c/h3\u003e\n\u003cp\u003eThe pigs were on a conventional cereal meal diet twice daily. Oral intake, animal wellbeing and behaviour were monitored daily per animal facility standard procedures and listed in a diary. The animals\u0026rsquo; weight was recorded once a week. A follow-up upper endoscopy was performed once a week under sedation (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg) to inspect the patency of the LAMS. Endoscopic removal of all LAMS was performed at week 10. Removed LAMS were examined for tissue interposition.\u003c/p\u003e\n\u003ch3\u003eEuthanasia and final examination\u003c/h3\u003e\n\u003cp\u003eAt week 12, a final upper endoscopy was performed to inspect the patency of the gastroenterostomy without LAMS. Next the animals were euthanized (Tiletamine/Zolazepam 6mg/kg and Xylazine 2 mg/kg associated with injection of T-61) and at necropsy, gross examination of the peritoneal cavity was performed to search for signs of inflammation, infection or abscesses. Each anastomosis was surgically resected and examined macroscopically. The diameter of each anastomosis was recorded using a ring size measure rod. Then the resected anastomosis segment was individually mounted to measure the anastomotic tensile strength and breaking point (\u003cstrong\u003esupplementary materials\u003c/strong\u003e: Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003es). The maximal anastomotic tensile strength (MATS) corresponded to the complete rupture of the anastomosis. The progressive lengthening of the anastomosis by the applied traction force was also measured. Similarly, tensile strength and breaking point of a normal jejunal segment was studied.\u003c/p\u003e\n\u003ch3\u003eStudy endpoints\u003c/h3\u003e\n\u003cp\u003ePrimary endpoints of the prospective animal study were the comparison of the technical outcomes and easiness of the WEST and DTOG EUS-GE techniques. Secondary endpoints were technical success of salvage therapy using the LAMS-in-LAMS technique, patency of the anastomosis and anastomotic tensile strength analysis.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical analysis\u003c/h2\u003e\n \u003cp\u003eCategorical variables were compared using \u0026chi;\u0026sup2; or Fisher-exact tests. Normal and non-normally distributed variables were presented as mean (SD) and median (range). They were analysed using the Student t-test, Mann-Whitney U-test or Kruskal-Wallis test accordingly. A two-sided \u003cem\u003ep-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/em\u003e was considered statistically significant. An internal validation of the VAS of the easiness of the procedure was assessed using Efron\u0026rsquo;s enhanced bootstrap method [\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e]. This method was applied to confirm the agreement between the qualitative response of the questionnaire and the score on the VAS of the easiness of the procedure. Statistical analyses were carried out using TIBO Statistica v13.3 software (University of Montpellier, research laboratory MRE-TRIS France).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 10 pigs were divided in two groups : 5 pigs randomly underwent the DTOG and 5 pigs the WEST technique.\u003c/p\u003e\n\u003ch3\u003eComparison of the outcomes of WEST and DTOG technique\u003c/h3\u003e\n\u003cp\u003e11 EUS-GE were performed with 5 in the DTOG group and 6 in the WEST group. A flow chart (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e) resumes the follow-up of the experiment. The mean time required to insert the oro-intestinal drain was 18.5 min\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6 min and the mean number of attempts was 1.4. The mean distention diameter of the target intestinal limb at the start of the EUS-GE procedure was 21.2 mm in the WEST group and 20.8 mm in the DTOG group without significant difference (p\u0026thinsp;=\u0026thinsp;0.84). Technical success to create the EUS-GE was higher in the WEST group than the DTOG group, which turned out to be more difficult to perform (100% vs 60% respectively, p\u0026thinsp;=\u0026thinsp;0.18). The rate of involuntary misdeployment was lower in the WEST group than in the DTOG group (33.3% vs 100% respectively, p\u0026thinsp;=\u0026thinsp;0.06). In the DTOG group, two pigs needed to be euthanized at the end of the procedure due to failure of endoscopic salvage therapy after spontaneous misdeployment. The mean procedure time was significantly lower in the WEST group than in the DTOG group (17\u0026thinsp;\u0026plusmn;\u0026thinsp;8 min vs 69\u0026thinsp;\u0026plusmn;\u0026thinsp;18 min respectively, p\u0026thinsp;=\u0026thinsp;0.002). The number of attempts was significantly lower in the WEST group than in the DTOG group ( 1.3 vs 6.7 respectively, p\u0026thinsp;=\u0026thinsp;0.003). Results are listed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe mean VAS score for technical easiness (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) was significantly higher in the WEST group than the DTOG group (7/10 vs 1/10 respectively, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The Efron\u0026rsquo;s enhanced boostrap method confirmed the agreement between the qualitative responses of the questionnaire and the quantitative score of the VAS (\u003cb\u003esupplementary material\u003c/b\u003e: Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003es).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eTechnical outcomes of both EUS-GE techniques\u003c/b\u003e (WEST\u0026thinsp;=\u0026thinsp;Wireless endoscopic simplified technique ; DTOG\u0026thinsp;=\u0026thinsp;Directed techniques over the guidewire ; EUS-GE\u0026thinsp;=\u0026thinsp;EUS guided gastroenterostomy ; VAS\u0026thinsp;=\u0026thinsp;Visual analogue scale)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eWEST technique\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDTOG technique\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eProbability\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical outcomes of oro-intestinal catheter\u003c/p\u003e \u003cp\u003e- Mean time (min)\u003c/p\u003e \u003cp\u003e- Mean number of attempts (n)\u003c/p\u003e \u003cp\u003e- Mean distention jejunal limb(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003cp\u003e18.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6\u003c/p\u003e \u003cp\u003e1.4\u003c/p\u003e \u003cp\u003e21\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003cp\u003e18.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.5\u003c/p\u003e \u003cp\u003e1.6\u003c/p\u003e \u003cp\u003e21.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003cp\u003e18\u0026thinsp;\u0026plusmn;\u0026thinsp;2.4\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e20.8\u0026thinsp;\u0026plusmn;\u0026thinsp;2.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNA\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.78\u003c/p\u003e \u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.02\u003c/b\u003e\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical success of EUS-GE (n\u0026nbsp;; %)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (81.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (60%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInvoluntary LAMS misdeployment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.06\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical outcomes of EUS-GE\u003c/p\u003e \u003cp\u003e- Mean number of attempts (n)\u003c/p\u003e \u003cp\u003e- Mean time (min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e34.4\u0026thinsp;\u0026plusmn;\u0026thinsp;23.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.3\u003c/p\u003e \u003cp\u003e17\u0026thinsp;\u0026plusmn;\u0026thinsp;7.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6.7\u003c/p\u003e \u003cp\u003e69.3\u0026thinsp;\u0026plusmn;\u0026thinsp;17.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.003\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.002\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluation of easiness of the procedure\u003c/p\u003e \u003cp\u003e- Mean VAS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4/10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7/10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1/10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003eP\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eEndoscopic rescue therapy with LAMS-in-LAMS\u003c/h2\u003e \u003cp\u003eA total of 9 LAMS-in-LAMS were performed in 8 living pigs. Technical success of the LAMS-in-LAMS was 81.8%. A spontaneous distal migration of the two co-axial LAMS without clinical consequence was reported in one pig one week after the initial procedure (11.1%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePatency of the anastomosis after LAMS-in-LAMS\u003c/h2\u003e \u003cp\u003eFollow-up upper endoscopy was performed every week during 10 weeks in the 8 remaining pigs, confirming the correct position and patency of the LAMS. No occlusion of the LAMS due to food impaction or tissue overgrowth was observed. All the LAMS (with a diameter of 16 mm) were endoscopically removed at week 10 using a rat tooth forceps. In all pigs, the co-axial LAMS were impacted in each other without tissue interposition (\u003cb\u003esupplementary materials\u003c/b\u003e: Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003es\u003cb\u003e).\u003c/b\u003e Endoscopic control prior to the necropsy confirmed patency of the gastroenterostomy in all pigs (8/8). Moreover the gastroenterostomy was accessible with the endoscope in 7/8 pigs (87.5%). During the necropsy, signs of peritoneal inflammation with micro-abscesses were found in one pig (1/8, 12.5%). After the necropsy, the mean diameter of the anastomosis was measured at 13.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2 mm with a mean reduction of the diameter of 1.85 mm [0 ; 9.5]. Histological examination of one anastomosis confirmed fibrotic fusion of the gastric and jejunal tissues with formation of scar tissue (\u003cb\u003esupplementary material\u003c/b\u003e: Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003es).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eAnastomotic physical resistance analyse\u003c/h2\u003e \u003cp\u003ePhysical resistance of the anastomosis was studied in 7 pigs. Among them, one anastomosis was used to test compatibility with a tensile strength testing machine without success. Therefore, the point of rupture force was analysed in 6 anastomoses and tissue elasticity was analysed in 5 by applying progressive gradual traction force. The mean MATS was 27.46\u0026thinsp;\u0026plusmn;\u0026thinsp;5.07 N and the mean lengthening of the anastomosis was 7.76\u0026thinsp;\u0026plusmn;\u0026thinsp;1.75 mm until rupture. During the tensile strength test, all the models ruptured at the level of the anastomosis. Physical resistance of the jejunal tissue was studied in 6 pigs. The mean maximal jejunal tensile strength was 13.48\u0026thinsp;\u0026plusmn;\u0026thinsp;2.72 N. The mean lengthening of the jejunal tissue was 87.4\u0026thinsp;\u0026plusmn;\u0026thinsp;38.8 mm until rupture. All these results were reported in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eResults of physical resistance of anastomotic and jejunal tissue\u003c/b\u003e (MATS\u0026thinsp;=\u0026thinsp;maximal anastomotic tensile strength ; MJTS\u0026thinsp;=\u0026thinsp;maximal jejunal tensile strength; N\u0026thinsp;=\u0026thinsp;Newton)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePig 4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePig 6\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePig 7\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePig 8\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePig 9\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePig 10\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysical resistance of the anastomosis:\u003c/p\u003e \u003cp\u003e- MATS (N)\u003c/p\u003e \u003cp\u003e- Lengthening of anastomosis (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36.29\u003c/p\u003e \u003cp\u003eNA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.44\u003c/p\u003e \u003cp\u003e5.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e30.4\u003c/p\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20.4\u003c/p\u003e \u003cp\u003e6.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27.95\u003c/p\u003e \u003cp\u003e11.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e21.58\u003c/p\u003e \u003cp\u003e8.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e27.46\u0026thinsp;\u0026plusmn;\u0026thinsp;5.07\u003c/p\u003e \u003cp\u003e7.76\u0026thinsp;\u0026plusmn;\u0026thinsp;1.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysical resistance of the jejunal segment:\u003c/p\u003e \u003cp\u003e- MJTS (N)\u003c/p\u003e \u003cp\u003e- Lengthening of jejunal tissue (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14.7\u003c/p\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.14\u003c/p\u003e \u003cp\u003e124\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.2\u003c/p\u003e \u003cp\u003e77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.28\u003c/p\u003e \u003cp\u003e130\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7.36\u003c/p\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e13.73\u003c/p\u003e \u003cp\u003e57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e13.48\u0026thinsp;\u0026plusmn;\u0026thinsp;2.72\u003c/p\u003e \u003cp\u003e87.4\u0026thinsp;\u0026plusmn;\u0026thinsp;38.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eWe conducted a longitudinal porcine study to compare the outcomes of the WEST and DTOG techniques to perform EUS-GE and to evaluate the outcomes of endoscopic rescue therapy using the LAMS-in-LAMS technique. A comparison of different classical outcomes was performed. Technical success was higher in the WEST group with a shorter procedure time needing less attempts as compared to the DTOG group. Moreover, the risk of involuntary LAMS misdeployment was lower in the WEST group than in the DTOG group, illustrating that the DTOG technique using a guidewire is more difficult than the free-hand WEST technique. These results confirm the superiority of the WEST technique over the DTOG technique for the creation of EUS-GE, as recently shown in a clinical retrospective human study [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The WEST technique appears easier than the DTOG technique to perform EUS-GE as shown by the higher VAS score. Magahis et al. previously showed that the majority (71.4%) of EUS experts performing EUS-GE prefer the WEST technique because of its better technical feasibility and outcome [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Therefore, the WEST technique should be advocated as the standardized method of choice to perform EUS-GE, as shown both in animal and clinical studies.\u003c/p\u003e \u003cp\u003eSince the risk of LAMS misdeployment is an important issue hampering the wide spread use of the EUS-GE technique, we also studied the effectiveness of salvage techniques and to evaluate the patency of the anastomosis after the LAMS-in-LAMS rescue technique. This stent-in-stent technique is suggested for the treatment of misdeployment type II [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. However, with the stent-in-stent technique for type II misdeployment, the jejunal wall is captured between the flares of the co-axial LAMS, possibly reducing the chance of a correct fibrotic fusion of the gastric and jejunal wall. There are currently no animal or human studies on the outcomes and patency of EUS-GE after rescue therapy using this technique. Our survival porcine study clearly demonstrated the feasibility, effectiveness and safety of the LAMS-in-LAMS technique as a rescue therapy in case of stent misdeployment type II with a technical success 81.8%. The high technical rescue success rate was most likely related to the introduction of a guide wire to secure the tract before the voluntary misdeployment. The guide wire seems therefore mandatory in the event of misdeployment type II in order to maintain access through the jejunal orifice and is best inserted after the jejunal flange has been deployed. Earlier insertion of the guidewire may increase the risk of pushing away the target limb, as seen in the DTOG technique. This explains the higher rate of involuntary LAMS misdeployment in the DTOG group compared to the WEST group (100% vs 33%, p\u0026thinsp;=\u0026thinsp;0.06). This idea was also reported by some experts questioned in the study of Magahis et al.[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Therefore, in case of doubt or difficult LAMS release, it is advocated to keep a guide wire ready to be introduced into the jejunal lumen once the jejunal flange is opened, before completion of the procedure. The guide wire can help to rescue the procedure in case of LAMS migration out of the jejunal lumen into the peritoneal cavity while applying traction onto the stent before the release of the gastric flange.\u003c/p\u003e \u003cp\u003eIn addition, the patency of the gastroenterostomy was excellent even after LAMS-in-LAMS technique during 10 weeks in all pigs, indicating that the jejunal tissue interposition between the two co-axial stents does not seem to mortgage the technical and clinical success of the rescued EUS-GE. However, after the removal of the LAMS, a mean reduction in the anastomotic diameter of 1.85 mm was noted. This progressive reduction of the diameter was also reported in 2 out 3 animals in the porcine study by Gonzalez et al. [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. The ideal LAMS dwelling time resulting in a permanent and functional EUS-GE anastomosis is currently unknown. However, in the EUS-directed trans-gastric ERCP (EDGE) procedure, a comparable technique to create a gastrogastrostomy or jejunogastrostomy in Roux-en-Y gastric bypass, the only factor identified for persistent fistula is a long mean LAMS dwelling time (\u0026gt;\u0026thinsp;40 days in situ) [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. In our study, the LAMS was kept in place for 70 days. It appears that the LAMS dwelling time is not the only factor explaining the progressive reduction of the anastomotic diameter after removal of the LAMS. The reduction of the diameter is part of the healing processes of a non-surgical anastomosis, that is activated after the removal of the LAMS. However, in view of the expansion of EUS-GE indications to treat benign gastric outlet obstruction, long term patency after removal of the LAMS is warranted. This information is of the utmost importance, and further studies should focus on this topic.\u003c/p\u003e \u003cp\u003eThe current study also focussed on the LAMS-in-LAMS rescue technique with biomechanical analysis of tensile and breaking force of the anastomosis created with the risk of tissue interposition between the two co-axial stents. It is the first study to introduce the concept of anastomotic physical resistance in EUS-GE. The mean MATS was 27,46\u0026thinsp;\u0026plusmn;\u0026thinsp;5.07N before rupture of the anastomosis. The tensile strength appeared to be better at the level of the fibrotic anastomosis as compared to normal jejunal tissue. In the literature, the mean maximal tensile strength in surgical small bowel anastomosis was 13.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.76 N [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. The resistance of the EUS-GE anastomosis, even after rescue therapy, was therefore at least equivalent to that of a surgical intestinal anastomosis in terms of biomechanical properties, despite the jejunal wall interposition between the two co-axial stents. The results of our study are encouraging, showing that the EUS-GE anastomosis is of reliable biomechanical quality even after the LAMS-in-LAMS rescue technique. However, comparisons must be made with caution, as the results in the literature relate only to small intestinal anastomosis, whereas the results of our study relate to gastrointestinal anastomosis. In addition, the tensile strength measurements should be performed in a standardized uniform way.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe WEST technique appears to be simpler and safer than the DTOG technique to perform EUS-GE in this porcine animal model. However, in case of misdeployment type II, LAMS-in-LAMS technique over the guide wire was shown technically successful and resulted in a good patency of the anastomosis. The biomechanical results of MATS after rescue therapy even outclassed the MATS of surgical small bowel anastomosis in the literature. The current study added valuable information to the knowledge of the recently developed EUS-GE technique and how to overcome failures using the stent-in-stent rescue method. Further animal studies are needed to compare MATS of surgical and EUS-guided anastomoses.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDATA AVAILABILITY\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study available from the corresponding author on reasonable request.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eACKNOWLEDGEMENTS\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eEuropean Society of Gastrointestinal Endoscopy (ESGE) grant 2021\u003c/li\u003e\n \u003cli\u003ePrion Medical (Belgium) and Taewoong Medical (Korea) for the free provision of HotSpaxus 16*20 mm LAMS.\u003c/li\u003e\n \u003cli\u003eERBE (Belgium) for the free provision of the electrosurgical unit.\u003c/li\u003e\n \u003cli\u003eOlympus (Belgium) for the free provision of the EUS endoscope and ultrasound machine.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor’s contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTG MOREELS, M. BARTHET, JM GONZALEZ and L MONINO concepted the study and analyzed the results.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePH DEPREZ,\u0026nbsp;R. EVRARD, E.BONACORSI helped to develop the concept for the soft tissue study.\u003c/p\u003e\n\u003cp\u003eTG MOREELS and L MONINO performed therapeutic endoscopy.\u003c/p\u003e\n\u003cp\u003eP BALDINanalyzed the histologic samples.\u003c/p\u003e\n\u003cp\u003eL MONINO wrote the first draft of the manuscript. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTG MOREELS adapted the first draft of the manuscript.\u003c/p\u003e\n\u003cp\u003eAll authors provided critical revision and correction of the manuscript and approved the final draft\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval :\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the university ethical committee for animal studies (2021/UCL/MD/072).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of interest\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLaurent MONINO is a consultant for Fujifilm, COOK Medical, Boston Scientific, Prion Medical, AlphaSigma and Braun Medical and received speaker’s fees from Olympus Belgium and Olympus Europe. Jean-Michel GONZALEZ and Marc BARTHET are consultants for Boston Scientific. \u0026nbsp; Pierre H. DEPREZ is a consultant for Boston Scientific and Olympus Europe. \u0026nbsp;Tom G. MOREELS\u0026nbsp;received speaker’s fees from Olympus Belgium and Olympus Europe.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eIqbal, U. et al. EUS-guided gastroenterostomy for the management of gastric outlet obstruction: A systematic review and meta-analysis. \u003cem\u003eEndoscopic Ultrasound\u003c/em\u003e. \u003cb\u003e9\u003c/b\u003e, 16\u0026ndash;23 (2020).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcCarty, T. R. et al. Efficacy and safety of EUS-guided gastroenterostomy for benign and malignant gastric outlet obstruction: a systematic review and meta-analysis. \u003cem\u003eEndosc Int. 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Endosc\u003c/em\u003e. \u003cb\u003e97\u003c/b\u003e, 260\u0026ndash;267 (2023).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"EUS-guided gastroenterostomy, lumen-apposing metal stent, LAMS misdeployment, animal study, tensile strength","lastPublishedDoi":"10.21203/rs.3.rs-6287871/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6287871/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e EUS-guided gastroenterostomy (EUS-GE) proved efficacy and safety for the management of gastric outlet obstruction (GOO). Nevertheless, lack of standardization and lumen-apposing metal stent (LAMS) misdeployment are limiting its spread. The aim was to compare the wireless endoscopic simplified technique (WEST) and the direct technique over a guided-wire (DTOG) and to evaluate patency and maximal anastomotic tensile strength (MATS) after LAMS-in-LAMS salvage therapy.\u003c/p\u003e \u003cp\u003eA prospective animal study was performed comparing DTOG and WEST techniques. After performing an EUS-GE, LAMS-in-LAMS was performed to treat involuntary or voluntary LAMS misdeployment. The animals were followed during 12 weeks. Primary endpoints included technical success, safety and easiness of the EUS-GE, while secondary endpoints included patency and MATS of the anastomosis.\u003c/p\u003e \u003cp\u003e11 EUS-GE were performed in 10 living pigs. The WEST had a high technical success (100% vs 60%; p\u0026thinsp;=\u0026thinsp;0.180), less voluntary misdeployment (33.3% vs 100%, p\u0026thinsp;=\u0026thinsp;0.060), significantly high easiness score (7/10 vs 1/10; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) and high technical outcomes compared to DTOG. Concerning LAMS-in-LAMS, technical success was 81.8%. At week 10 LAMS were removed and at week 12, the anastomosis diameter reduced by an average of 1.85 mm [range 0-9.5 mm]. The mean MATS was 27.46\u0026thinsp;\u0026plusmn;\u0026thinsp;5.07 N.\u003c/p\u003e \u003cp\u003eWEST resulted in higher technical success as compared to DTOG to create EUS-GE. In case of LAMS misdeployment, the LAMS-in-LAMS proofed to be a reliable rescue therapy with a good anastomotic patency and tensile strength.\u003c/p\u003e","manuscriptTitle":"Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stent: an animal study comparison of wireless and over-the-wire techniques","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-21 06:07:11","doi":"10.21203/rs.3.rs-6287871/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-08-14T13:52:25+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-14T13:05:30+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"144805868947995954334388149966993395373","date":"2025-08-14T11:45:52+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-14T09:00:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"105140425538207067560226067540157456292","date":"2025-08-14T08:11:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"174370512949052820558232643220357013311","date":"2025-08-14T07:04:28+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-28T02:09:43+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"126267990357256716249635195365752131201","date":"2025-05-16T07:22:19+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-05-16T04:59:35+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-05-16T04:55:53+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-04-18T10:49:17+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-18T06:27:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2025-03-23T11:01:31+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3d863614-ce6f-40ff-bac0-07bca487da5f","owner":[],"postedDate":"May 21st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":48680751,"name":"Health sciences/Gastroenterology"},{"id":48680752,"name":"Health sciences/Gastroenterology/Gastrointestinal models"},{"id":48680753,"name":"Health sciences/Gastroenterology/Oesophagogastroscopy"}],"tags":[],"updatedAt":"2025-12-22T16:01:47+00:00","versionOfRecord":{"articleIdentity":"rs-6287871","link":"https://doi.org/10.1038/s41598-025-27688-1","journal":{"identity":"scientific-reports","isVorOnly":false,"title":"Scientific Reports"},"publishedOn":"2025-12-16 15:57:53","publishedOnDateReadable":"December 16th, 2025"},"versionCreatedAt":"2025-05-21 06:07:11","video":"","vorDoi":"10.1038/s41598-025-27688-1","vorDoiUrl":"https://doi.org/10.1038/s41598-025-27688-1","workflowStages":[]},"version":"v1","identity":"rs-6287871","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6287871","identity":"rs-6287871","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}