Stepwise Pressure Release Reduces Bleeding Complications after Endoscopic Papillary Balloon Dilation: A Retrospective Cohort Study

Stepwise Pressure Release Reduces Bleeding Complications after Endoscopic Papillary Balloon Dilation: A Retrospective Cohort Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Stepwise Pressure Release Reduces Bleeding Complications after Endoscopic Papillary Balloon Dilation: A Retrospective Cohort Study Xianrong Liu, Xiaojun Zhou, Qiong Yan, Juan Yin, Jianfeng Cao, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9186039/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective The objective of this study was to investigate whether a stepwise pressure release technique reduces the risk of intraoperative and postoperative bleeding complications after Endoscopic Papillary Balloon Dilation (EPBD). Methods This retrospective cohort study included patients with common bile duct stones who underwent ERCP accompanied by EST and EPBD at Nanhua University Affiliated Nanhua Hospital. The observation group (stepwise pressure release, n = 757) consisted of patients treated between April 1, 2022 and October 31, 2025, and the control group (conventional one‑time release, n = 784) comprised those treated between January 1, 2020 and February 28, 2022. Following EPBD, balloon pressure in the observation group was released in four steps (25% per step at 60‑second intervals), whereas the control group underwent conventional immediate deflation. Outcome measures included intraoperative bleeding severity grade, postoperative reduction in hemoglobin level, incidence of hematemesis and melena, and other complications. Results The baseline characteristics were balanced between the two groups (P > 0.05). The distribution of intraoperative bleeding severity differed significantly (P < 0.001): the observation group had predominantly Grade 0 (52.18%) and Grade 1 (32.63%) bleeding, while the control group had mainly Grade 1 (43.49%) and Grade 2 (28.06%). The postoperative hemoglobin drop was lower in the observation group (10.57 ± 6.65 g/L) than in the control group (13.62 ± 7.86 g/L, P < 0.0001). The incidence of melena was also lower in the observation group (12.95%) compared to the control group (22.45%, P 0.05). Conclusion The stepwise pressure release technique after EPBD significantly reduces intraoperative bleeding severity, minimizes postoperative hemoglobin drop and melena occurrence, without increasing the risk of other complications. It represents a safe and effective technical modification. EPBD Stepwise pressure release Bleeding ERCP Complication prevention Figures Figure 1 INTRODUCTION Endoscopic Papillary Balloon Dilation (EPBD) is a standard procedure in ERCP and endoscopic bile duct stone extraction. To minimize trauma to the Oddi sphincter, preserve its function, and achieve the goals of stone clearance or improvement of bile outflow, endoscopists often adopt the technique of minor duodenal papilla incision combined with EPBD-performing a limited sphincterotomy followed by dilation of the narrowed area using a larger balloon. Particularly in the extraction of larger bile duct stones (diameter > 10 mm), EPBD is often indispensable. To preserve the function of the Oddi sphincter, several ERCP-related practice guidelines recommend the use of graded dilation during EPBD procedures [ 1 , 2 ] . However, after balloon dilation is completed, the pressure inside the balloon is typically released all at once. Following the release of pressure, the duodenal papilla often exhibits varying degrees of bleeding at the wound site. However, whether a stepwise release of the balloon pressure can mitigate this bleeding has not been formally investigated. In recent years, researchers have adopted the method of gradually releasing the balloon pressure after EPBD to observe whether it can reduce the occurrence of hemorrhagic complications. METHODS Study Participants This was a retrospective cohort study. This study used a non-concurrent (historical) control design. The observation group consisted of patients with common bile duct stones treated with ERCP, EST, and EPBD between April 1, 2022, and October 31, 2025. The control group was drawn from a separate, earlier time period (January 1, 2020, to February 28, 2022) and underwent the same treatment regimen. All patients were from the same department (Department of Hepatobiliary Surgery, Nanhua University Affiliated Nanhua Hospital). Inclusion criteria: (1) Patients diagnosed with common bile duct stones based on imaging and laboratory examinations; (2) Age ≥ 18 years; (3) Informed consent and ability to cooperate with postoperative follow-up. Exclusion criteria: (1) Patients with severe coagulation dysfunction; (2) Patients with other diseases causing biliary obstruction (e.g., ampullary malignancies). This study was conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all patients after a thorough discussion of the surgical procedure and its potential risks; the study protocol was approved by the Ethics Review Committee of Affiliated Nanhua Hospital, University of South China (Approval No.: Y250724). Endoscopic Procedure Control Group The patient was placed in the prone position. A duodenoscope (FUJIFILM ED-580T, Japan) was inserted orally and advanced through the esophagus to the descending duodenum. At the major duodenal papilla, a sphincterotome (Olympus, Japan) with a guidewire (Olympus, Japan) was used for selective cannulation of the bile duct. After injecting contrast medium into the bile duct, X-ray fluoroscopy was employed to observe the biliary structure, diameter, and the location and size of stones. Based on the cholangiogram findings, endoscopic sphincterotomy (EST) was performed first, followed by selection of an appropriately sized dilation balloon (Boston Scientific, USA). A medical balloon pressure pump (Changzhou Jiuhong Medical Equipment Co., Ltd., China) was used to inflate the balloon gradually. After maintaining the target pressure for 30 seconds, the pressure was released in a single, rapid deflation. Immediate bleeding was then observed and scored. Subsequent therapeutic procedures, such as stone extraction or stent placement, were performed. Postoperatively, the patient's vital signs and abdominal symptoms/signs were routinely monitored to prevent and promptly manage potential complications. Observation Group The ERCP and EPBD procedures were identical to those in the control group. Following EPBD, the pressure from the inflation pump was released in a stepwise manner, divided into four stages. At each stage, 25% of the total inflation pressure was released, with a 60-second interval between each stage of pressure release. All other procedural steps and postoperative management were the same as in the control group. Observation Parameters The following were compared between the two groups: baseline patient characteristics, intraoperative bleeding severity score (see Table 1 ), incidence of postoperative gastrointestinal bleeding (hematemesis and melena), reduction in hemoglobin level, incidence of acute cholangitis, and incidence of post-ERCP pancreatitis. Table 1 Intraoperative Bleeding Severity Score Grade Endoscopic Findings Score Grade 0 The operative field is clean, with no signs of active bleeding or oozing. 0 Grade 1 Mild, slow oozing is observed from the wound. 1 Grade 2 Distinct active bleeding, such as flowing blood or pulsatile bleeding from a small arteriole, with a moderate rate of hemorrhage. 2 Grade 3 Active, rapid arterial spurting or extensive, flowing hemorrhage. 3 Grade 4 Life-threatening massive hemorrhage. The endoscopic field is completely obscured by blood, making anatomical structures unrecognizable. 4 Quality Control (1) The Department of Hepatobiliary Surgery at Affiliated Nanhua Hospital, University of South China is a provincial-level key clinical specialty in Hunan Province. The medical and nursing team members have undergone rigorous training and possess extensive experience in ERCP procedures and perioperative management. (2) Case selection strictly adhered to the inclusion and exclusion criteria. The research process was standardized, transparent, and fully safeguarded patients' rights to informed consent and other relevant interests. (3) All observation indicators were objective. Patient data were collected using standardized methods to ensure completeness, accuracy, and consistency of the data. Statistics Statistical analysis was performed using SPSS software (version 23.0). Normally distributed continuous data (e.g., age) are presented as mean ± standard deviation (SD) and were compared between groups using the independent samples *t*-test. Non-normally distributed continuous data are presented as median (interquartile range) and were compared between groups using the Mann-Whitney U test. Categorical data are presented as frequency (percentage) and were compared between groups using the chi-square test or Fisher's exact probability test. A two-sided P < 0.05 was considered statistically significant. RESULTS Baseline Clinical Characteristics A total of 784 patients in the control group and 757 patients in the observation group were enrolled according to the inclusion and exclusion criteria. No statistically significant differences were observed between the two groups in terms of age, gender, or preoperative bilirubin levels. The baseline clinical characteristics of the patients in both groups are presented in Table 2 . Table 2 Comparison of Baseline Characteristics Between the Two Groups (Mean ± SD) Characteristic Observation Group (n = 757) Control Group (n = 784) p-value Age, years (Mean ± SD) 61.23 ± 8.59 60.78 ± 8.67 0.306 Gender, n (%) 0.849 Male 368 (48.6) 391 (49.9) Female 389 (51.4) 393 (50.1) Maximum diameter of bile duct stones (mm) 9.07 ± 2.44 9.11 ± 2.59 0.761 Dilation diameter of EPBD (mm) 10.13 ± 0.92 10.09 ± 0.94 0.728 Total Bilirubin Level (µmol/L) 36.18 ± 10.51 35.76 ± 11.72 0.457 APTT,s(Mean ± SD) 29.07 ± 2.88 28.89 ± 3.02 0.233 Intraoperative Bleeding Immediate grading after EPBD showed that in the observation group, Grade 0 and Grade 1 bleeding accounted for the highest proportions, at 52.18% and 32.63%, respectively. In the control group, Grade 1 and Grade 2 bleeding were most prevalent, accounting for 43.49% and 28.06%, respectively, with 33 cases (4.21%) classified as Grade 3. Comparison between the two groups revealed a highly statistically significant difference in the distribution of endoscopic bleeding grades (P < 0.001). In terms of percentage distribution and effect size, the overall bleeding severity in the observation group was lower than that in the control group (the observation group had a higher proportion of Grade 0 bleeding and a lower proportion of high-grade bleeding). Table 3 Endoscopic Bleeding Grade Between the Two Groups Endoscopic Bleeding Grade Observation Group, n (%) Control Group, n (%) Grade 0 395(52.18) 187(23.85) Grade 1 247(32.63) 341(43.49) Grade 2 106(14.00) 220(28.06) Grade 3 7(0.92) 33(4.21) Grade 4 2(0.27) 3(0.81) Postoperative Hemoglobin Decline Patients underwent a complete blood count review at 24 hours postoperatively to compare the decline in hemoglobin levels between the two groups. As shown in Fig. 1 ,The results showed a decline in hemoglobin in both groups, with the control group exhibiting a decrease of 13.62 ± 7.86 g/L and the observation group a decrease of 10.57 ± 6.65 g/L. The hemoglobin decline in the observation group was significantly less than that in the control group, with a statistically significant difference (t = -7.56, P < 0.0001). Incidence of Postoperative Hematemesis and Melena The incidence of hematemesis and melena within 72 hours postoperatively was observed. The results showed that no cases of hematemesis occurred in the observation group, while 98 cases (12.95%) experienced melena. In the control group, 4 cases (0.51%) had hematemesis and 176 cases (22.45%) had melena. The incidence of both hematemesis and melena was lower in the observation group compared to the control group, with a statistically significant difference in melena incidence between the two groups (P < 0.01). Incidence of Postoperative Non-hemorrhagic Complications The occurrence of complications such as ERCP-related pancreatitis, acute cholangitis, and intestinal or biliary perforation within 72 hours postoperatively was observed in both groups. The results indicated no statistically significant difference in the incidence of these complications between the two groups. Table 4 Comparison of Postoperative Complications Between the Two Groups Group Hematemesis, n (%) Melena, n (%) Post-ERCP Pancreatitis,n (%) Acute Cholangitis, n (%) Intestinal or Biliary Perforation, n (%) Observation Group(n = 757) 0(0) 98(12.95) 131(17.31) 54(7.13) 3(0.40) Control Group(n = 784) 4(0.51) 176(22.45) 140(17.86) 65(8.29) 2(0.25) χ²-value N/A 23.85 0.07 0.73 N/A p - value 0.125 0.001 0.791 0.394 0.681 Note : The dash (N/A) indicates that Fisher’s exact test was employed because the expected cell count was < 5; thus, the χ² value was not calculated. DISCUSSION The duodenal papilla is highly vascularized—an anatomical feature that, while essential, makes it particularly prone to bleeding during endoscopic procedures. As a result, minimizing hemorrhagic complications during and after EPBD and stone extraction remains a critical concern for endoscopists. This concern becomes even more pronounced in complex cases. Several studies have shown that patients with large bile duct stones (diameter > 10 mm) or impacted ampullary stones often require a more extensive sphincterotomy and greater balloon dilation during EST and EPBD. These maneuvers inevitably increase mechanical trauma to the surrounding biliary tissues and raise the risk of postoperative bleeding [ 3 – 6 ] . Although combining EST with EPBD may offer advantages over either technique alone for managing common bile duct stones [ 7 ] , it does not eliminate the inherent bleeding risk associated with tissue disruption. In conventional EPBD, regardless of whether a graded inflation technique is used, balloon pressure is typically released all at once immediately after dilation. This abrupt decompression can trigger sudden hemodynamic changes in the compressed microvasculature of the papillary wound, frequently leading to immediate bleeding. In our experience, such bleeding is commonly observed upon balloon removal. While minor oozing may stop spontaneously, more severe cases often require endoscopic hemostasis-using electrocoagulation, local injection of vasoactive agents (e.g., diluted epinephrine), or hemoclips. Although effective, these interventions prolong procedure time and can cause additional tissue injury. Moreover, once post-ERCP bleeding develops, management becomes particularly demanding. Patients may require intensive monitoring, repeat endoscopic procedures, surgical salvage, or blood transfusions—all of which place a substantial burden on both the individual and the healthcare system. Given these challenges, exploring simple technical modifications that can reduce bleeding risk has clear clinical value. In recent clinical observations at our center, we noted that varying degrees of wound bleeding occurred in the majority of patients (76.15%) following EST and EPBD. Although hemostasis was successfully achieved in most cases through the application of local hemostatic agents (e.g., norepinephrine, biological hemostatic powders) or hemostatic clips, the incidence of postoperative melena reached 22.45%, accompanied by varying degrees of hemoglobin decline, indicating a persistent risk of delayed bleeding. By modifying the EPBD technique to incorporate stepwise balloon pressure release, we observed a significant reduction in wound bleeding under endoscopy, thereby lowering the risk of delayed postoperative hemorrhage, without a significant increase in complications such as ERCP-related pancreatitis, acute cholangitis, or intestinal/biliary perforation. Our findings demonstrate that stepwise balloon pressure release significantly reduced immediate bleeding upon balloon removal and lowered the incidence of postoperative hemorrhagic complications. We believe this effect can be attributed to several interrelated mechanisms. First, gradual pressure release allows the compressed arterioles, venules, and capillaries within the duodenal papilla to reperfuse progressively, rather than suddenly. This controlled reperfusion provides sufficient time for the coagulation cascade to become fully activated at sites of vascular injury, enabling timely formation of local microthrombi before hemodynamic forces can dislodge them. Second, by avoiding abrupt reperfusion, stepwise decompression minimizes the shear stress of blood flow on freshly severed vessel ends, thereby reducing blood extravasation. Third, this technique may promote contraction of vascular smooth muscle, which further helps to curb bleeding. Finally, the gradual reduction in Oddi sphincter tension allows for more complete recovery of sphincter fiber contractile function, potentially compressing the local vascular bed and contributing to hemostasis. Together, these mechanisms suggest that stepwise pressure release creates a more favorable hemodynamic and hemostatic environment during the critical moments following balloon deflation. In conclusion, this study demonstrates that stepwise pressure release following EPBD significantly reduces intraoperative bleeding severity, attenuates postoperative hemoglobin decline, and lowers the incidence of melena, without increasing the risk of other complications. These findings suggest that this modified technique is both safe and effective in clinical practice. However, as a single-center study focused exclusively on patients with biliary stones, our results may carry inherent selection bias and may not be generalizable to other biliary conditions. Future multicenter collaborations and prospective studies are warranted to validate these findings and to explore the applicability of this technique in a broader spectrum of biliary disorders. Abbreviations EPBD : Endoscopic Papillary Balloon Dilation ERCP : Endoscopic Retrograde Cholangiopancreatography EST : Endoscopic Sphincterotomy Declarations Ethics approval and consent to participate This study was conducted in accordance with the ethical principles of the Declaration of Helsinki. As this is a retrospective study utilizing anonymized clinical data, the requirement for individual informed consent was waived by the Ethics Review Committee of Affiliated Nanhua Hospital, University of South China. The study protocol was reviewed and approved by the same committee (Approval No.: Y250724). Consent for publication Not applicable. Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This study was funded by the Medical-Health Joint Program of the Hunan Provincial Natural Science Foundation (Grant No. 2025JJ81076) and Scientific Research Project of Hunan Provincial Department of Education - Outstanding Youth Project（Grant No. 22B0414）. Disclosures Drs. Liu Xianrong, Zhou Xiaojun, Yan Qiong, Yin Juan, Cao Jianfeng, Duan Shijiao, Long Jianwu, and Lu Xianzhou have no conflicts of interest or financial ties to disclose. Acknowledgements The authors thank the medical and nursing teams of the Department of Hepatobiliary Surgery, Affiliated Nanhua Hospital, University of South China, for their clinical support and collaboration. Author Contribution Author ContributionsConceptualization: X.Liu.Methodology & Investigation: X.Liu, J.Long.Data Curation & Formal Analysis: X.Liu, J.Long, Q.Yan, J.Yin, J.Cao, S.Duan.Writing – Original Draft: X.Liu.Writing – Review & Editing: X.Lu, X.Zhou.Supervision: X.Lu, X.Zhou.All authors read and approved the final manuscript. References Li Peng, Wang Yongjun, Wang Wenhai. Guidelines for the Diagnosis and Treatment of ERCP (2018 Edition) [J]. Chinese Journal of Practical Internal Medicine, 2018, 38(11): 1041–1072. DOI: 10.19538/j.nk2018110167 . Dumonceau JM, Kapral C, Aabakken L, et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020;52(2):127–149. doi: 10.1055/a-1075-4080 . Epub 2019 Dec 20. PMID: 31863440. Parras Castañera E, Rodríguez López P, Álvarez A, et al. Predictive factors for post-ERCP bleeding. Influence of direct oral anticoagulants. Rev Esp Enferm Dig. 2021;113(8):591–596. doi: 10.17235/reed.2020.7547/2020 . PMID: 33371701. Altunpak B, Aydin H, Cebi F, et al. Post-ERCP Pancreatitis Risk Factors: Is Post-Sphincterotomy Bleeding Another Risk Factor? Surg Laparosc Endosc Percutan Tech. 2024;34(1):69–73. doi: 10.1097/SLE.0000000000001251. PMID: 38063573. Barakat M, Saumoy M, Forbes N, et al. Complications of Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2025;169(2):230–243.e8. doi: 10.1053/j.gastro.2025.03.009 . Epub 2025 Mar 20. PMID: 40120770. Yu Z, He J, Cao R, et al. Proton pump inhibitor has no effect in the prevention of post-endoscopic sphincterotomy delayed bleeding: a prospective randomized controlled trial. Front Med (Lausanne). 2023;10:1179512. doi: 10.3389/fmed.2023.1179512 . PMID: 37332745; PMCID: PMC10272718. Ooi JS, Ikhwan SM, Azem Fathi MA, et al. Endoscopic sphincterotomy with balloon dilatation versus sphincterotomy alone for common bile duct stones removal: a randomised controlled trial. Med J Malaysia. 2024;79(2):133–140. PMID: 38553916. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-9186039","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":613164476,"identity":"68cc3842-6401-4f52-875e-2c5a2b06896f","order_by":0,"name":"Xianrong Liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2UlEQVRIiWNgGAWjYBACPhiDn7354AMGAyK0sMEYkj3Hkg1I02Iww0dNgiiHsbH3Hn5dUXHHboMED1vlj4I78gzsh49uwKuF51ya5Zkzz5K3S/ceu81j8MywgSct7QZeLRI5ZoaNbYeTLeecS7vNYHCYsUGCx4w4LQY3cswKfxgctidGi/FDoBY7kBYGHoPDiYS18JwxY2w4czgBFMjSQC3JbYT8ws/eY/yxoeKwPSgqP/74c9i2n/3wMbxawG4DEokNcC4B5SDA/AFI2BOhcBSMglEwCkYqAACNqUyAjQR/TQAAAABJRU5ErkJggg==","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":true,"prefix":"","firstName":"Xianrong","middleName":"","lastName":"Liu","suffix":""},{"id":613164477,"identity":"19a30eb9-7d44-4f2e-9468-f20f619a5ee9","order_by":1,"name":"Xiaojun Zhou","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Xiaojun","middleName":"","lastName":"Zhou","suffix":""},{"id":613164478,"identity":"cde0dd10-f193-44a4-b9e8-0b5d7b7884c9","order_by":2,"name":"Qiong Yan","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Qiong","middleName":"","lastName":"Yan","suffix":""},{"id":613164479,"identity":"23df4c3e-a7b5-4da0-937e-6b2720902505","order_by":3,"name":"Juan Yin","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Juan","middleName":"","lastName":"Yin","suffix":""},{"id":613164480,"identity":"23053cf6-0e79-4966-88e1-bcbfcac947e3","order_by":4,"name":"Jianfeng Cao","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Jianfeng","middleName":"","lastName":"Cao","suffix":""},{"id":613164481,"identity":"faddc0d9-39b2-44a0-a0cc-b5324e111aa7","order_by":5,"name":"Shijiao Duan","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Shijiao","middleName":"","lastName":"Duan","suffix":""},{"id":613164482,"identity":"83effaaa-8cdc-41aa-9ba5-472e62b58826","order_by":6,"name":"Jianwu Long","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Jianwu","middleName":"","lastName":"Long","suffix":""},{"id":613164483,"identity":"f1c8e00a-f436-482a-87a0-0bb98b008683","order_by":7,"name":"Xianzhou Lu","email":"","orcid":"","institution":"Affiliated Nanhua Hospital, University of South China","correspondingAuthor":false,"prefix":"","firstName":"Xianzhou","middleName":"","lastName":"Lu","suffix":""}],"badges":[],"createdAt":"2026-03-21 13:23:45","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9186039/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9186039/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105786673,"identity":"c144daef-a2cc-47fa-8afe-77c2ac23b1a6","added_by":"auto","created_at":"2026-03-31 06:48:40","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":114690,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePostoperative hemoglobin decline in two groups of patients\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-9186039/v1/b0438a7997660363f1739e65.png"},{"id":108976344,"identity":"861f7358-912f-4a60-bc85-0f1e743ebb9c","added_by":"auto","created_at":"2026-05-11 11:05:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":314899,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9186039/v1/b93870ca-9148-4946-b89e-90282678149a.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Stepwise Pressure Release Reduces Bleeding Complications after Endoscopic Papillary Balloon Dilation: A Retrospective Cohort Study","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eEndoscopic Papillary Balloon Dilation (EPBD) is a standard procedure in ERCP and endoscopic bile duct stone extraction. To minimize trauma to the Oddi sphincter, preserve its function, and achieve the goals of stone clearance or improvement of bile outflow, endoscopists often adopt the technique of minor duodenal papilla incision combined with EPBD-performing a limited sphincterotomy followed by dilation of the narrowed area using a larger balloon. Particularly in the extraction of larger bile duct stones (diameter\u0026thinsp;\u0026gt;\u0026thinsp;10 mm), EPBD is often indispensable.\u003c/p\u003e \u003cp\u003eTo preserve the function of the Oddi sphincter, several ERCP-related practice guidelines recommend the use of graded dilation during EPBD procedures \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. However, after balloon dilation is completed, the pressure inside the balloon is typically released all at once. Following the release of pressure, the duodenal papilla often exhibits varying degrees of bleeding at the wound site. However, whether a stepwise release of the balloon pressure can mitigate this bleeding has not been formally investigated. In recent years, researchers have adopted the method of gradually releasing the balloon pressure after EPBD to observe whether it can reduce the occurrence of hemorrhagic complications.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Participants\u003c/h2\u003e \u003cp\u003eThis was a retrospective cohort study. This study used a non-concurrent (historical) control design. The observation group consisted of patients with common bile duct stones treated with ERCP, EST, and EPBD between April 1, 2022, and October 31, 2025. The control group was drawn from a separate, earlier time period (January 1, 2020, to February 28, 2022) and underwent the same treatment regimen. All patients were from the same department (Department of Hepatobiliary Surgery, Nanhua University Affiliated Nanhua Hospital).\u003c/p\u003e \u003cp\u003eInclusion criteria: (1) Patients diagnosed with common bile duct stones based on imaging and laboratory examinations; (2) Age\u0026thinsp;\u0026ge;\u0026thinsp;18 years; (3) Informed consent and ability to cooperate with postoperative follow-up.\u003c/p\u003e \u003cp\u003eExclusion criteria: (1) Patients with severe coagulation dysfunction; (2) Patients with other diseases causing biliary obstruction (e.g., ampullary malignancies).\u003c/p\u003e \u003cp\u003e This study was conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all patients after a thorough discussion of the surgical procedure and its potential risks; the study protocol was approved by the Ethics Review Committee of Affiliated Nanhua Hospital, University of South China (Approval No.: Y250724).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eEndoscopic Procedure\u003c/h3\u003e\n\u003cp\u003eControl Group\u003c/p\u003e \u003cp\u003eThe patient was placed in the prone position. A duodenoscope (FUJIFILM ED-580T, Japan) was inserted orally and advanced through the esophagus to the descending duodenum. At the major duodenal papilla, a sphincterotome (Olympus, Japan) with a guidewire (Olympus, Japan) was used for selective cannulation of the bile duct. After injecting contrast medium into the bile duct, X-ray fluoroscopy was employed to observe the biliary structure, diameter, and the location and size of stones. Based on the cholangiogram findings, endoscopic sphincterotomy (EST) was performed first, followed by selection of an appropriately sized dilation balloon (Boston Scientific, USA). A medical balloon pressure pump (Changzhou Jiuhong Medical Equipment Co., Ltd., China) was used to inflate the balloon gradually. After maintaining the target pressure for 30 seconds, the pressure was released in a single, rapid deflation. Immediate bleeding was then observed and scored. Subsequent therapeutic procedures, such as stone extraction or stent placement, were performed. Postoperatively, the patient's vital signs and abdominal symptoms/signs were routinely monitored to prevent and promptly manage potential complications.\u003c/p\u003e \u003cp\u003eObservation Group\u003c/p\u003e \u003cp\u003eThe ERCP and EPBD procedures were identical to those in the control group. Following EPBD, the pressure from the inflation pump was released in a stepwise manner, divided into four stages. At each stage, 25% of the total inflation pressure was released, with a 60-second interval between each stage of pressure release. All other procedural steps and postoperative management were the same as in the control group.\u003c/p\u003e \u003cp\u003eObservation Parameters\u003c/p\u003e \u003cp\u003eThe following were compared between the two groups: baseline patient characteristics, intraoperative bleeding severity score (see Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), incidence of postoperative gastrointestinal bleeding (hematemesis and melena), reduction in hemoglobin level, incidence of acute cholangitis, and incidence of post-ERCP pancreatitis.\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\u003eIntraoperative Bleeding Severity Score\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEndoscopic Findings\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eScore\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe operative field is clean, with no signs of active bleeding or oozing.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMild, slow oozing is observed from the wound.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDistinct active bleeding, such as flowing blood or pulsatile bleeding from a small arteriole, with a moderate rate of hemorrhage.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eActive, rapid arterial spurting or extensive, flowing hemorrhage.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLife-threatening massive hemorrhage. The endoscopic field is completely obscured by blood, making anatomical structures unrecognizable.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eQuality Control\u003c/h3\u003e\n\u003cp\u003e(1) The Department of Hepatobiliary Surgery at Affiliated Nanhua Hospital, University of South China is a provincial-level key clinical specialty in Hunan Province. The medical and nursing team members have undergone rigorous training and possess extensive experience in ERCP procedures and perioperative management.\u003c/p\u003e \u003cp\u003e(2) Case selection strictly adhered to the inclusion and exclusion criteria. The research process was standardized, transparent, and fully safeguarded patients' rights to informed consent and other relevant interests.\u003c/p\u003e \u003cp\u003e(3) All observation indicators were objective. Patient data were collected using standardized methods to ensure completeness, accuracy, and consistency of the data.\u003c/p\u003e\n\u003ch3\u003eStatistics\u003c/h3\u003e\n\u003cp\u003eStatistical analysis was performed using SPSS software (version 23.0). Normally distributed continuous data (e.g., age) are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) and were compared between groups using the independent samples *t*-test. Non-normally distributed continuous data are presented as median (interquartile range) and were compared between groups using the Mann-Whitney U test. Categorical data are presented as frequency (percentage) and were compared between groups using the chi-square test or Fisher's exact probability test. A two-sided P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eBaseline Clinical Characteristics\u003c/h2\u003e \u003cp\u003eA total of 784 patients in the control group and 757 patients in the observation group were enrolled according to the inclusion and exclusion criteria. No statistically significant differences were observed between the two groups in terms of age, gender, or preoperative bilirubin levels. The baseline clinical characteristics of the patients in both groups are presented 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\u003eComparison of Baseline Characteristics Between the Two Groups (Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eObservation Group (n\u0026thinsp;=\u0026thinsp;757)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eControl Group (n\u0026thinsp;=\u0026thinsp;784)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years (Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e61.23\u0026thinsp;\u0026plusmn;\u0026thinsp;8.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60.78\u0026thinsp;\u0026plusmn;\u0026thinsp;8.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.306\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.849\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e368 (48.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e391 (49.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e389 (51.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e393 (50.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaximum diameter of bile duct stones (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.07\u0026thinsp;\u0026plusmn;\u0026thinsp;2.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.11\u0026thinsp;\u0026plusmn;\u0026thinsp;2.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.761\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDilation diameter of EPBD (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.13\u0026thinsp;\u0026plusmn;\u0026thinsp;0.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.09\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.728\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal Bilirubin Level (\u0026micro;mol/L)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36.18\u0026thinsp;\u0026plusmn;\u0026thinsp;10.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.76\u0026thinsp;\u0026plusmn;\u0026thinsp;11.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.457\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAPTT,s(Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29.07\u0026thinsp;\u0026plusmn;\u0026thinsp;2.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.89\u0026thinsp;\u0026plusmn;\u0026thinsp;3.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.233\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\n\u003ch3\u003eIntraoperative Bleeding\u003c/h3\u003e\n\u003cp\u003eImmediate grading after EPBD showed that in the observation group, Grade 0 and Grade 1 bleeding accounted for the highest proportions, at 52.18% and 32.63%, respectively. In the control group, Grade 1 and Grade 2 bleeding were most prevalent, accounting for 43.49% and 28.06%, respectively, with 33 cases (4.21%) classified as Grade 3. Comparison between the two groups revealed a highly statistically significant difference in the distribution of endoscopic bleeding grades (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). In terms of percentage distribution and effect size, the overall bleeding severity in the observation group was lower than that in the control group (the observation group had a higher proportion of Grade 0 bleeding and a lower proportion of high-grade bleeding).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEndoscopic Bleeding Grade Between the Two Groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndoscopic Bleeding Grade\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eObservation Group, n (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eControl Group, n (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e395(52.18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e187(23.85)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e247(32.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e341(43.49)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e106(14.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e220(28.06)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e7(0.92)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e33(4.21)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2(0.27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3(0.81)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003ePostoperative Hemoglobin Decline\u003c/h3\u003e\n\u003cp\u003ePatients underwent a complete blood count review at 24 hours postoperatively to compare the decline in hemoglobin levels between the two groups. As shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e,The results showed a decline in hemoglobin in both groups, with the control group exhibiting a decrease of 13.62\u0026thinsp;\u0026plusmn;\u0026thinsp;7.86 g/L and the observation group a decrease of 10.57\u0026thinsp;\u0026plusmn;\u0026thinsp;6.65 g/L. The hemoglobin decline in the observation group was significantly less than that in the control group, with a statistically significant difference (t = -7.56, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eIncidence of Postoperative Hematemesis and Melena\u003c/h2\u003e \u003cp\u003eThe incidence of hematemesis and melena within 72 hours postoperatively was observed. The results showed that no cases of hematemesis occurred in the observation group, while 98 cases (12.95%) experienced melena. In the control group, 4 cases (0.51%) had hematemesis and 176 cases (22.45%) had melena. The incidence of both hematemesis and melena was lower in the observation group compared to the control group, with a statistically significant difference in melena incidence between the two groups (P\u0026thinsp;\u0026lt;\u0026thinsp;0.01).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eIncidence of Postoperative Non-hemorrhagic Complications\u003c/h2\u003e \u003cp\u003eThe occurrence of complications such as ERCP-related pancreatitis, acute cholangitis, and intestinal or biliary perforation within 72 hours postoperatively was observed in both groups. The results indicated no statistically significant difference in the incidence of these complications between the two groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of Postoperative Complications Between the Two Groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHematemesis,\u003c/p\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMelena,\u003c/p\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePost-ERCP Pancreatitis,n (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAcute Cholangitis,\u003c/p\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eIntestinal or Biliary Perforation,\u003c/p\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eObservation Group(n\u0026thinsp;=\u0026thinsp;757)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e98(12.95)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e131(17.31)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e54(7.13)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3(0.40)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eControl Group(n\u0026thinsp;=\u0026thinsp;784)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(0.51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e176(22.45)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e140(17.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e65(8.29)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2(0.25)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eχ\u0026sup2;-value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e23.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.73\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ep\u003cem\u003e-\u003c/em\u003evalue\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.125\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.791\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.394\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.681\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003cb\u003eNote\u003c/b\u003e: The dash (N/A) indicates that Fisher\u0026rsquo;s exact test was employed because the expected cell count was \u0026lt;\u0026thinsp;5; thus, the χ\u0026sup2; value was not calculated.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe duodenal papilla is highly vascularized\u0026mdash;an anatomical feature that, while essential, makes it particularly prone to bleeding during endoscopic procedures. As a result, minimizing hemorrhagic complications during and after EPBD and stone extraction remains a critical concern for endoscopists. This concern becomes even more pronounced in complex cases. Several studies have shown that patients with large bile duct stones (diameter\u0026thinsp;\u0026gt;\u0026thinsp;10 mm) or impacted ampullary stones often require a more extensive sphincterotomy and greater balloon dilation during EST and EPBD. These maneuvers inevitably increase mechanical trauma to the surrounding biliary tissues and raise the risk of postoperative bleeding \u003csup\u003e[\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Although combining EST with EPBD may offer advantages over either technique alone for managing common bile duct stones \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e, it does not eliminate the inherent bleeding risk associated with tissue disruption.\u003c/p\u003e \u003cp\u003eIn conventional EPBD, regardless of whether a graded inflation technique is used, balloon pressure is typically released all at once immediately after dilation. This abrupt decompression can trigger sudden hemodynamic changes in the compressed microvasculature of the papillary wound, frequently leading to immediate bleeding. In our experience, such bleeding is commonly observed upon balloon removal. While minor oozing may stop spontaneously, more severe cases often require endoscopic hemostasis-using electrocoagulation, local injection of vasoactive agents (e.g., diluted epinephrine), or hemoclips. Although effective, these interventions prolong procedure time and can cause additional tissue injury. Moreover, once post-ERCP bleeding develops, management becomes particularly demanding. Patients may require intensive monitoring, repeat endoscopic procedures, surgical salvage, or blood transfusions\u0026mdash;all of which place a substantial burden on both the individual and the healthcare system. Given these challenges, exploring simple technical modifications that can reduce bleeding risk has clear clinical value.\u003c/p\u003e \u003cp\u003eIn recent clinical observations at our center, we noted that varying degrees of wound bleeding occurred in the majority of patients (76.15%) following EST and EPBD. Although hemostasis was successfully achieved in most cases through the application of local hemostatic agents (e.g., norepinephrine, biological hemostatic powders) or hemostatic clips, the incidence of postoperative melena reached 22.45%, accompanied by varying degrees of hemoglobin decline, indicating a persistent risk of delayed bleeding. By modifying the EPBD technique to incorporate stepwise balloon pressure release, we observed a significant reduction in wound bleeding under endoscopy, thereby lowering the risk of delayed postoperative hemorrhage, without a significant increase in complications such as ERCP-related pancreatitis, acute cholangitis, or intestinal/biliary perforation.\u003c/p\u003e \u003cp\u003eOur findings demonstrate that stepwise balloon pressure release significantly reduced immediate bleeding upon balloon removal and lowered the incidence of postoperative hemorrhagic complications. We believe this effect can be attributed to several interrelated mechanisms. First, gradual pressure release allows the compressed arterioles, venules, and capillaries within the duodenal papilla to reperfuse progressively, rather than suddenly. This controlled reperfusion provides sufficient time for the coagulation cascade to become fully activated at sites of vascular injury, enabling timely formation of local microthrombi before hemodynamic forces can dislodge them. Second, by avoiding abrupt reperfusion, stepwise decompression minimizes the shear stress of blood flow on freshly severed vessel ends, thereby reducing blood extravasation. Third, this technique may promote contraction of vascular smooth muscle, which further helps to curb bleeding. Finally, the gradual reduction in Oddi sphincter tension allows for more complete recovery of sphincter fiber contractile function, potentially compressing the local vascular bed and contributing to hemostasis. Together, these mechanisms suggest that stepwise pressure release creates a more favorable hemodynamic and hemostatic environment during the critical moments following balloon deflation.\u003c/p\u003e \u003cp\u003eIn conclusion, this study demonstrates that stepwise pressure release following EPBD significantly reduces intraoperative bleeding severity, attenuates postoperative hemoglobin decline, and lowers the incidence of melena, without increasing the risk of other complications. These findings suggest that this modified technique is both safe and effective in clinical practice. However, as a single-center study focused exclusively on patients with biliary stones, our results may carry inherent selection bias and may not be generalizable to other biliary conditions. Future multicenter collaborations and prospective studies are warranted to validate these findings and to explore the applicability of this technique in a broader spectrum of biliary disorders.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003eEPBD\u003c/strong\u003e: Endoscopic Papillary Balloon Dilation\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eERCP\u003c/strong\u003e: Endoscopic Retrograde Cholangiopancreatography\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEST\u003c/strong\u003e: Endoscopic Sphincterotomy\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the ethical principles of the Declaration of Helsinki. As this is a retrospective study utilizing anonymized clinical data, the requirement for individual informed consent was waived by the Ethics Review Committee of Affiliated Nanhua Hospital, University of South China. The study protocol was reviewed and approved by the same committee (Approval No.: Y250724).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by the Medical-Health Joint Program of the Hunan Provincial Natural Science Foundation (Grant No. 2025JJ81076) and Scientific Research Project of Hunan Provincial Department of Education - Outstanding Youth Project（Grant No. 22B0414）.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDrs. Liu Xianrong, Zhou Xiaojun, Yan Qiong, Yin Juan, Cao Jianfeng, Duan Shijiao, Long Jianwu, and Lu Xianzhou have no conflicts of interest or financial ties to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the medical and nursing teams of the Department of Hepatobiliary Surgery, Affiliated Nanhua Hospital, University of South China, for their clinical support and collaboration.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAuthor ContributionsConceptualization: X.Liu.Methodology \u0026amp; Investigation: X.Liu, J.Long.Data Curation \u0026amp; Formal Analysis: X.Liu, J.Long, Q.Yan, J.Yin, J.Cao, S.Duan.Writing \u0026ndash; Original Draft: X.Liu.Writing \u0026ndash; Review \u0026amp; Editing: X.Lu, X.Zhou.Supervision: X.Lu, X.Zhou.All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLi Peng, Wang Yongjun, Wang Wenhai. Guidelines for the Diagnosis and Treatment of ERCP (2018 Edition) [J]. Chinese Journal of Practical Internal Medicine, 2018, 38(11): 1041\u0026ndash;1072. DOI:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.19538/j.nk2018110167\u003c/span\u003e\u003cspan address=\"10.19538/j.nk2018110167\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDumonceau JM, Kapral C, Aabakken L, et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020;52(2):127\u0026ndash;149. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1055/a-1075-4080\u003c/span\u003e\u003cspan address=\"10.1055/a-1075-4080\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub 2019 Dec 20. PMID: 31863440.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eParras Casta\u0026ntilde;era E, Rodr\u0026iacute;guez L\u0026oacute;pez P, \u0026Aacute;lvarez A, et al. Predictive factors for post-ERCP bleeding. Influence of direct oral anticoagulants. Rev Esp Enferm Dig. 2021;113(8):591\u0026ndash;596. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.17235/reed.2020.7547/2020\u003c/span\u003e\u003cspan address=\"10.17235/reed.2020.7547/2020\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 33371701.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAltunpak B, Aydin H, Cebi F, et al. Post-ERCP Pancreatitis Risk Factors: Is Post-Sphincterotomy Bleeding Another Risk Factor? Surg Laparosc Endosc Percutan Tech. 2024;34(1):69\u0026ndash;73. doi: 10.1097/SLE.0000000000001251. PMID: 38063573.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarakat M, Saumoy M, Forbes N, et al. Complications of Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2025;169(2):230\u0026ndash;243.e8. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1053/j.gastro.2025.03.009\u003c/span\u003e\u003cspan address=\"10.1053/j.gastro.2025.03.009\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub 2025 Mar 20. PMID: 40120770.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu Z, He J, Cao R, et al. Proton pump inhibitor has no effect in the prevention of post-endoscopic sphincterotomy delayed bleeding: a prospective randomized controlled trial. Front Med (Lausanne). 2023;10:1179512. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fmed.2023.1179512\u003c/span\u003e\u003cspan address=\"10.3389/fmed.2023.1179512\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 37332745; PMCID: PMC10272718.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOoi JS, Ikhwan SM, Azem Fathi MA, et al. Endoscopic sphincterotomy with balloon dilatation versus sphincterotomy alone for common bile duct stones removal: a randomised controlled trial. Med J Malaysia. 2024;79(2):133\u0026ndash;140. PMID: 38553916.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"EPBD, Stepwise pressure release, Bleeding, ERCP, Complication prevention","lastPublishedDoi":"10.21203/rs.3.rs-9186039/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9186039/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThe objective of this study was to investigate whether a stepwise pressure release technique reduces the risk of intraoperative and postoperative bleeding complications after Endoscopic Papillary Balloon Dilation (EPBD).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis retrospective cohort study included patients with common bile duct stones who underwent ERCP accompanied by EST and EPBD at Nanhua University Affiliated Nanhua Hospital. The observation group (stepwise pressure release, n\u0026thinsp;=\u0026thinsp;757) consisted of patients treated between April 1, 2022 and October 31, 2025, and the control group (conventional one‑time release, n\u0026thinsp;=\u0026thinsp;784) comprised those treated between January 1, 2020 and February 28, 2022. Following EPBD, balloon pressure in the observation group was released in four steps (25% per step at 60‑second intervals), whereas the control group underwent conventional immediate deflation. Outcome measures included intraoperative bleeding severity grade, postoperative reduction in hemoglobin level, incidence of hematemesis and melena, and other complications.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe baseline characteristics were balanced between the two groups (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). The distribution of intraoperative bleeding severity differed significantly (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001): the observation group had predominantly Grade 0 (52.18%) and Grade 1 (32.63%) bleeding, while the control group had mainly Grade 1 (43.49%) and Grade 2 (28.06%). The postoperative hemoglobin drop was lower in the observation group (10.57\u0026thinsp;\u0026plusmn;\u0026thinsp;6.65 g/L) than in the control group (13.62\u0026thinsp;\u0026plusmn;\u0026thinsp;7.86 g/L, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). The incidence of melena was also lower in the observation group (12.95%) compared to the control group (22.45%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.01). No significant differences were found between the groups in the incidence of non-bleeding complications such as post-ERCP pancreatitis and acute cholangitis (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe stepwise pressure release technique after EPBD significantly reduces intraoperative bleeding severity, minimizes postoperative hemoglobin drop and melena occurrence, without increasing the risk of other complications. It represents a safe and effective technical modification.\u003c/p\u003e","manuscriptTitle":"Stepwise Pressure Release Reduces Bleeding Complications after Endoscopic Papillary Balloon Dilation: A Retrospective Cohort Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-31 06:48:36","doi":"10.21203/rs.3.rs-9186039/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"87d3f2f7-e8f3-4271-9bb0-c14fce9e7ef0","owner":[],"postedDate":"March 31st, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-21T13:57:28+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-31 06:48:36","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9186039","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9186039","identity":"rs-9186039","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}