Competency Curve in Sentinel Lymph Node Biopsy in Early-Stage Endometrial Cancer: Prospective Single Institute Study in a Tertiary Care Institute in North East India

Competency Curve in Sentinel Lymph Node Biopsy in Early-Stage Endometrial Cancer: Prospective Single Institute Study in a Tertiary Care Institute in North East India | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 23 September 2025 V1 Latest version Share on Competency Curve in Sentinel Lymph Node Biopsy in Early-Stage Endometrial Cancer: Prospective Single Institute Study in a Tertiary Care Institute in North East India Authors : Zoya Siddiqui [email protected] , Debabrata Barmon , Upasana Baruah , Dimpy Begum , and Shiraj Ahmed Authors Info & Affiliations https://doi.org/10.22541/au.175865416.63572405/v1 176 views 110 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: Sentinel lymph node biopsy (SLNB) has emerged as a less morbid alternative to complete lymphadenectomy for nodal staging in endometrial cancer. However, its adoption requires institutional validation and assessment of the learning curve. This study evaluated the competency curve for SLNB using CUSUM (cumulative sum) analysis in early-stage endometrial cancer at a tertiary cancer centre in North East India. Methods: A prospective cohort study was conducted between November 2023 and November 2024 including 21 patients with clinically early-stage endometrial carcinoma. SLNB was performed using indocyanine green (ICG) and near-infrared imaging, followed by pelvic lymphadenectomy in all cases as per the MSKCC algorithm. Bilateral SLN detection and confirmation of lymphoid tissue on histopathology defined successful SLN mapping. Empty packet was defined as excised tissue presumed intraoperatively to be nodal but lacking lymphoid elements on final histopathology. CUSUM analysis was used to assess the learning curve for bilateral and successful SLN detection. Results: The median age of patients was 55 years, with median BMI of 28.8 kg/m 2 . Laparotomy was performed in 76.2% of cases. At least one SLN was detected in 85.7% (18/21), bilateral SLN mapping in 52.4% (11/21), and overall successful SLN detection in 42.9% (9/21). Failed mapping occurred in 14.3% (3/21). Empty packets were noted in 9.5% (2/21), both in the para-aortic basin. False negative SLN was observed in 1 patient when analysed per patient, but none per hemipelvis. CUSUM analysis showed a significant improvement in bilateral and successful SLN detection after the 9th case (p=0.0014), with plateauing trends after 18 cases. Conclusion: SLNB in early-stage endometrial cancer demonstrates a clear learning curve, with competency improving significantly after 9 cases and plateauing after 18 cases. Empty packet rate and mapping failures highlight the importance of institutional validation. SLNB can be feasibly implemented even in low-resource settings, potentially replacing complete lymphadenectomy after adequate training and validation. Introduction Nodal staging in endometrial cancer provides critical prognostic information and guides adjuvant treatment decisions, though it offers no direct therapeutic benefit 1,2 . It is imperative for Staging and Risk stratification in endometrial cancer. In the era of precision medicine, where the goal is largely to obtain more information while minimising morbidity, Sentinel Lymph Node Biopsy (SLNB) is emerging as a less morbid alternative to complete lymphadenectomy. On the basis of the FIRES 3 trial and SENTOR trial 4 , demonstrating that sentinel lymph-node biopsy can be a surrogate marker of nodal assessment, NCCN 3 advocates for SLN mapping in apparent uterine-confined disease in patients with carcinoma endometrium in the absence of metastasis on the preoperative imaging 6 . Successful SLNB is owed to Bilateral detection of the sentinel lymph-node and the removal of lymphoid tissue in the final histopathology assessment. SLNB procedure mandates a definite Learning Curve with reported success increasing after 20 -40 7-9 cases. Each institute should validate its SLNB procedure to replace it with a comprehensive lymphadenectomy. The learning curve created with CUSUM analysis is a statistical method used to assess procedural competency that evolves. Materials and Methods A single-centre prospective cohort study was conducted in a tertiary care cancer centre between November 2023 and November 2024 at Dr Bhubaneshwar Borooah Cancer Institute, Guwahati, Assam, India. It included patients with Early-Stage Carcinoma-Endometrium (any histology) with Performance status 0/1, age 18 – 75 years and informed consent. Patients with previous hysterectomy/ uremia/ hepatic impairment, and Iodine allergy were excluded. Surgery was performed by 3 experienced gynae-oncology consultants. Using both the Laparoscopy and laparotomy approach and following the MSKCC-SLN algorithm 8 , ICG (Indocyanine Green) dye and Near Infrared Camera (NIR) were used for the dye localisation. 25mg ICG dye was diluted with 10mL of sterile water. After induction of anaesthesia, cervical injection of 2.5mg/ml ICG dye at 3o’ and 9o’ clock (0.5ml each) was administered. Depth of cervical injection was 1-3mm superficial and 1-2cm deep, using a 23-gauge spinal needle. The total ICG dye which was used is 5mg (2mL of the standard dose). The first Green afferent lymph node in an ICG-positive lymphatic channel after ICG administration under NIR was deemed as Sentinel Lymph node. The lymph nodes which are excised from each hemipelvis that didn’t take up the ICG dye were deemed as Non-Sentinel Lymph Node. SLN was first detected transperitoneally, then if not visualised, then, detection was attempted after creation of the retroperitoneal spaces (Bilateral pararectal and paravesical). Side-specific reinjection of the dye was done if there was no detection after 10minutes of ICG injection. Failure of SLN mapping was defined as the inability to identify SLN even after reinjection. SLNB followed by comprehensive pelvic-lymphadenectomy was done in all the patients. Frozen section of SLN was not done. Each patient served as their own control. Successful SLN mapping, was described as detection rate of Bilateral ICG-positive + confirmation of lymphoid tissue on final histopathological examination were assessed. Empty packet was described as apparent nodal tissue which was thought to be nodal tissue but lacking lymphoid elements on final histopathological examination. Competency curve for the successful SLN and bilateral SLN detection was charted. All SLN were subjected to ultrastaging and non-SLN were stained with traditional haematoxylin and eosin staining only. For Ultrastaging the nodes were sectioned in 2mm intervals in bread-loaf fashion then fixed in formalin. 3 sections 50µm apart were made from each paraffin embedded cut. 1 st and 3 rd section underwent hematoxylin and eosin staining and 2 nd section was evaluated by immunohistochemistry- pancytokeratin AE1/AE3. If Hematoxylin and eosin staining of any of the two section revealed malignancy then immunohistochemistry in that particular cut was omitted. Final staging was done as per FIGO 2023 staging for carcinoma endometrium. CUSUM chart was used to assess detection of bilateral and successful SLN detection and the Wilcoxon rank sum test was used to compare success rate before and after cutoff. Fischer’s exact probability test was used for Odds ratio calculation. P value of Results 21 patients were included in the study (Table1). The median age of the cohort was 55 years, and median BMI was 28.8kg/m 2 (range 25-38.7). The surgical approach was Laparotomy in the majority i.e. 76.2% due to shared laparoscopic system with other surgical teams and scheduling conflicts and thereby leading to higher use of the abovementioned route. Low risk histology, Endometrioid adenocarcinoma Grade 1 or 2 comprised of majority of the patients i.e. 71.4%, and, 28.6% of the patients had high risk histology. Amongst the apparent uterine confined disease, only 1 patient was diagnosed as stage IVB disease due to presence of omental metastasis. The most prevalent stage in final histopathological report was stage IA2. Myometrial invasion in outer half was noted in 33.33% whereas, majority (66.66%) had less than or equal to 50% invasion. The intraoperative average blood loss was 266ml (100-700ml). Post operative complication, graded according to Clavien Dindo, was 20% patients had grade 1, 25 % grade 3 and 5% had grade 1. The mean SLN which were detected was 1.38 per patient, range being 0-4. The pelvic lymphadenectomy harvested a mean nodal count of 19.4 nodes per patient, range of 5-30 pelvic lymph-nodes. Only 1 patient had less than 10 pelvic lymph-nodes removed, rest all had 10 or more pelvic lymph-nodes excised. Table 1 Clinicopathological factors Age -Median (range, years) 55 (35-74) Histology % (number) Endometrioid adenocarcinoma Grade1 57.16 (12) Endometrioid adenocarcinoma Grade2 14.3 (3) Endometrioid adenocarcinoma Grade3 4.76 (1) Serous 19 (4) Carcinosarcoma 4.76 (1) Approach % (number) Laparoscopy 23.8 (5) Laparotomy 76.19 (16) Final FIGO 2023 stage number (%) IA1 2 (9.52) IA2 8 (38.09) IA3 1 (4.76) IB 1 (4.76) IIA 1 (4.76) IIB 1 (4.76) IIC 2 (9.52) IIIB1 1 (4.76) IIIC1 2 (9.52) IIIC2 1 (4.76) IV B 1 (4.76) Mean Nodal count (per patient) Pelvic 19.4 Para-aortic 2.2 Mean Sentinel Lymph-Node count (per patient) Pelvic 1.38 Para-aortic 0.19 Sentinel lymph-node mapping was unilateral in 7 cases,i.e. 33.33% and bilateral in 52.38% (11 patients). At least one SLN was detected in 18 cases,i.e. 85.71%. Failed mapping even after dye reinjection occurred in 3 cases(14.28%)- Case 7,11 and 12 (Table2). Case7 had pelvic lymph-node metastasis, and Case 11 had para aortic and pelvic lymph-node metastasis. Involvement of lymph node leading to obstruction might have caused failed mapping. Case 10 had parametrial invasion which might have disrupted lymphatic channels and thus leading to Failed mapping. No patient had ICG-induced toxicity. False negative SLN was seen in 1 patient, considering patient as the unit of analysis. However, considering hemipelvis as the unit of analysis, there were no false negatives. This patient had unilateral SLN detection on the right hemipelvis, which did not reveal malignancy in the SLN and non SLN of the right pelvic nodes. However, she had contralateral non SLN positive for malignancy, in the side where SLN was not detected, i.e. failed mapping on the left hemipelvis. There were 3 patients with nodal disease, 2 cases of stage IIIC1 and 1 case of stage IIIC2. Nodal positivity rate was 14.2% in the study cohort. Out of 2 patients of Stage IIIC1,one had detection of the contralateral SLN. Involved nodal metastasis was the reason of non-detection of SLN in the metastatic side. The patient had undergone four prior open abdominal surgeries, and at the current operation the hemipelvis harboring the metastatic lymph node was obscured by dense adhesions resulting from her surgical history. Similarly, in another case, there was a failed mapping even after reinjection of the dye. In the third case there were positive pelvic and para aortic lymph-node without any detection of SLN after dye reinjection. Table 2 Sentinel Lymph node mapping results Patients who underwent SLN procedure 21 At least one SLN detected,%(number) 85.71 (18) Bilateral SLN detected,%(number) 52.4 (11) Successful SLN detected,%(number) 42.85 (9) False Negative SLN, patient as unit of analysis 1 False Negative SLN, hemipelvis as unit of analysis 0 Failed SLN mapping 3, Case number 7,10,11 Dye reinjection 3, Case number 7, 10,11 Empty Packet 2, Case 5 and 15 Cumulative probability of bilateral SLN detection (Figure 1) started at around 33.33% by 3 rd case and remained constant through the 9 th case. A notable increase occurred between the 9th and 12th cases, with the probability rising to approximately 41.7% which indicated a steep increase of 8.4 percentage points. Further increase was noted at the 15th and 18th cases, where the cumulative probability reached 40% and 50%, respectively. The increase of cumulative probability between 15 th and 18 th case represented a significant 10 percentage point rise, which was the steepest observed in bilateral SLN detection. By 20 th case, the cumulative probability had reached the 50% mark. By the 21st case, the cumulative probability was 52.4%, suggesting improved bilateral detection outcomes if we kept increasing the number of cases. Figure 1 Bilateral SLN The Odds Ratio for decrease in the rate of Empty packets was 0.970 (95%CI 0.735-1.25, p= 0.807). It indicates a small but non-significant decrease in odds of empty packet occurrence as the number of case progresses. Each additional case decreased the incidence of Empty packet by 3%. Successful SLN was seen in only 9 patients owing to 11 patients with bilateral detection but with 2 of these patients having an empty packet (Figure 2). Both the patients who had empty packets, the concerned SLN was detected in the para-aortic basin, which did not reveal any lymphoid tissue in the final histopathological examination. However, both of these patients had Bilateral pelvic SLN detection which were not empty packets (true nodes on final histopathological examination), i.e. they had Successful Pelvic SLN detection but not overall successful SLN detection considering empty packet in para-aortic Lymph nodes. For successful SLN detection, the cumulative probability started at 0% and remains at this level through the 6th case. A slight increase to 11.1% is observed at the 9th case, and a more pronounced increase to 25% occurred by the 12 th case. This interval (9 to 12 cases) saw an increase of 13.9 percentage points, representing one of the steepest increases in the successful SLN detection. Subsequent increase was seen at the 15th case (26.7%) and at the 18th case (38.9%), with an additional 12.2 percentage point rise from 15 to 18 cases. By the 21st case, the cumulative probability reached 42.9% which indicated a slower but steady improvement in successful SLN detection, though it remains below 50% by the conclusion of the observed cases. The odds ratio for successful SLN detection was 1.07 (95% CI: 0.924-1.25, p=0.388). Each additional case had 7% increase in odds of Successful SLN detection (p =0.38), however it is not statistically significant. Figure 2 Successful SLN These charts reveal that Bilateral SLN Detection consistently showed a higher cumulative probability compared to Successful SLN Detection across all intervals. Bilateral detection reached over 50% by the 21st case which indicates a relatively higher likelihood of achieving bilateral detection success as the cumulative cases increase. In contrast, the cumulative probability of successful SLN detection progressed at a slower rate, peaking at around 42.9% by the final interval. The steepest increases in both the detections occurred around the middle intervals which is 9 to 18 cases. This observation underscores that these stages constitute critical transition points in the learning process, influencing the likelihood of achieving optimal SLN detection outcomes. Cumulative Bilateral SLN detection was 52.4%, with steep increase between 9 th and 12 th case, with maximum increase after 15 cases, being reciprocated in successful SLN also. After applying Wilcoxon’s rank sum test, it was seen that significant increase in Bilateral and successful SLN detection was seen after 9 th case (p= 0.0014). Discussion Our study aimed to assess the competency curve in SLNB in carcinoma endometrium, focusing on CUSUM analysis, Successful SLN detection and rate of empty packets. Our bilateral detection rate at the time of study completion was 52.4% comparable with the other randomised controlled trials validating SLNB in endometrial cancer. Bilateral SLN detection was 50% in the SENTI-ENDO study, 51% in the MSKCC study, 52% FIRES trial and 58% in the study which was conducted by Solimon et al 3,10-12 . Our study also emphasised on the concept of Successful SLN, defined as Bilateral SLN detection with removal of the lymph node, i.e. not an empty packet. Notably, para-aortic nodes were more likely to result in an empty packet. Nodal positivity was noted in 14.2% of patients, comparable to established literature. In all node-positive patients, either SLN was not detected or mapping failed, highlighting a critical limitation of SLNB—metastatic nodal disease itself may hinder dye uptake and SLN visualisation. Also, previous operative procedures may affect SLN detection. Therefore, caution must be exercised in interpreting negative SLNs in technically difficult or incomplete mapping scenarios. Kim et al in their study have demonstrated that for achieving proficiency in SLN mapping (bilateral SLN), a surgeon should have operated at least 27-28 cases. In their study they have also used the CUSUM analysis and 80 cases were taken. However, the study population was mixed that is it included endometrial as well as cervical cancer and was a retrospective analysis, rather than a prospective one 6 . Our prospective study noted that after the 18 th case, the CUSUM curve started to plateau for both bilateral SLN and successful SLN. The study cohort was homogeneous, consisting exclusively of clinically apparent stage I and II endometrial carcinoma cases, with all procedures performed at a single institution. Katherine Tucker et al attempted to define the learning curve and assessed the impact of the surgeon’s experience. They enrolled 317 patients with endometrial cancer retrospectively and found that plateau was observed after 40 cases to achieve a successful bilateral mapping rate. They found that every additional subsequent 10 cases had a 5% increase in chances of successful Sentinel lymph-node mapping with an 11% increase of a tissue removal bearing lymph node 7 . Our study had noted the bar as low as 18 cases to achieve comparable bilateral SLN detection. Also being a prospective study in a tertiary care centre with an experienced gynae-oncologist, we demonstrated a more real-time observation of successful SLN. Its chances improved by 7% after each additional case and the empty packet rate decreased by 3% after each case. Prospective study in literature done by Khoury Collado et al found that after 30 cases, the chances of detection rate of SLN increased to 94%, taking a 90% cutoff. The higher rate observed in their study compared to ours may be attributable to differences in procedure- i.e., dual dye injection along with cervical and fundal injection of the dye 13 . Our study also demonstrated feasibility of SLB in endometrial cancer in a low-resource setting , where laparotomy was the predominant surgical approach (76.2%) , primarily due to shared laparoscopic systems and infrastructural limitations . Despite this, acceptable bilateral and overall SLN detection rates were achieved. This highlights that, with adherence to protocol and structured surgical training, SLNB can be successfully implemented even in resource-constrained environments. Our experience underscores that high-cost infrastructure is not an absolute prerequisite for accurate nodal staging using SLNB in endometrial cancer. The occurrence of empty packets is increasingly being recognised as a potential quality indicator in SLNB for endometrial cancer. While not universally standardised, an empty packet rate below 5–10% is generally considered acceptable in centres with validated SLNB protocols. In our study, two patients (9.5%) had para-aortic SLNs that yielded empty packets. Both cases occurred early in the series and coincided with technically challenging dissections in the para-aortic region. These findings do align with observations that para-aortic mapping is associated with a higher likelihood of empty packets due to deeper anatomical location and difficulty in distinguishing fluorescence in adipose tissue. During institutional validation—where SLNB is followed by comprehensive lymphadenectomy—the empty packet rate, along with bilateral detection rate, sensitivity and false-negative rate, should be used as an intraoperative quality indicator. Limitation - Our study’s limitations included a small sample size. As most of the cases underwent laparotomy, it might affect the generalizability of the results when minimally invasive surgery is the norm. Conclusion: SLN detection in endometrial cancer shows a clear learning curve, with significant competency achieved after 9 cases and plateauing after 18 cases. With structured training and institutional validation, SLNB can be a feasible alternative to complete lymphadenectomy, even in low-resource settings. Reference- 1. Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Crocè C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25. 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Improving sentinel lymph node detection rates in endometrial cancer: how many cases are needed? Gynecol Oncol. 2009 Dec;115(3):453-5. doi: 10.1016/j.ygyno.2009.08.026. Epub 2009 Sep 19. PMID: 19767064. Supplementary Material File (image1.emf) Download 127.71 KB File (image2.emf) Download 133.33 KB Information & Authors Information Version history V1 Version 1 23 September 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords carcinoma of the endometrium: surgery developing countries: obstetrics and gynaecology gynaecological oncology gynaecological surgery: laparoscopy pathology: gynaecological Authors Affiliations Zoya Siddiqui [email protected] Dr Bhubaneswar Borooah Cancer Institute View all articles by this author Debabrata Barmon Dr Bhubaneswar Borooah Cancer Institute View all articles by this author Upasana Baruah Dr Bhubaneswar Borooah Cancer Institute View all articles by this author Dimpy Begum Dr Bhubaneswar Borooah Cancer Institute View all articles by this author Shiraj Ahmed Dr Bhubaneswar Borooah Cancer Institute View all articles by this author Metrics & Citations Metrics Article Usage 176 views 110 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Zoya Siddiqui, Debabrata Barmon, Upasana Baruah, et al. Competency Curve in Sentinel Lymph Node Biopsy in Early-Stage Endometrial Cancer: Prospective Single Institute Study in a Tertiary Care Institute in North East India. Authorea . 23 September 2025. DOI: https://doi.org/10.22541/au.175865416.63572405/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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