A Randomized Controlled Trial Comparing Antegrade Sphincterotomy Dovbenko (ASD) With Conventional Pull-Type Sphincterotomy in Patients Undergoing ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,521
- 试验地点
- 1
- 主要终点
- Composite incidence of major procedure-related adverse events
研究概览
简要总结
This study compares endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD) with conventional pull-type endoscopic sphincterotomy (EST) in patients undergoing transpapillary interventions for various indications, including biliary stone disease, major duodenal papilla stenosis, choledocholithiasis, and other conditions requiring access to the biliary and/or pancreatic ducts. The ASD technique is performed using a dedicated sphincterotome designed by Dr. Dovbenko. Both the technique and the device are patented in Ukraine (Patent No. UA 117987C2, 2019). This instrument enables selective incision of only the circular muscle layer of the sphincter of Oddi, thereby preserving its sphincteric function and minimizing trauma to the duodenal wall. The primary objective of the study is to evaluate the relative risk of procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and the need for cholecystectomy.
详细描述
Anatomical studies confirm that the sphincter of Oddi comprises an inner circular muscle layer, functionally and structurally distinct from the duodenum, and an outer longitudinal layer derived from the duodenal wall. Preservation of this architecture is critical to maintaining sphincteric function. Standard pull-type sphincterotomy frequently disrupts both layers and adjacent duodenal tissue, contributing to procedure-related complications in up to 23% of ERCPs, including bleeding (≤3%), perforation (≤1%), and post-sphincterotomy reflux complications.
Antegrade Sphincterotomy Dovbenko (ASD) was developed to address these limitations. Using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019), ASD enables selective incision of the circular layer while sparing the longitudinal layer and duodenal integrity.
This prospective, randomized, parallel-group trial (NCT04406961) enrolled 1,521 patients requiring transpapillary intervention for biliary or pancreatic indications. Patients were assigned to ASD (n=761) or conventional EST (n=760).
In the ASD group, a trend toward reduced major complications was observed (RR 0.55; 95% CI 0.18-1.67); however, this difference did not reach statistical significance, likely due to the low absolute number of events. Notably, cholecystectomy was avoided in 71.2% of ASD patients with gallstone disease, compared to approximately 10% in the EST group. Temporary stenting (5-10 days) was used selectively to manage post-procedural edema. ASD should be performed exclusively by endoscopists with advanced transpapillary expertise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
盲法说明
Due to the nature of the endoscopic surgical interventions, neither participants nor investigators (including endoscopists and treating physicians) could be blinded to treatment allocation. All outcomes were assessed using standardized, objective criteria as defined in the European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline on post-ERCP complications (2023) and the ESGE Technical Guideline on endoscopic sphincterotomy (2020).
入排标准
- 年龄范围
- 18 Years 至 102 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach and duodenum for the introduction of a duodenoscope to the major duodenal papilla.
排除标准
- •The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.
结局指标
主要结局
Composite incidence of major procedure-related adverse events
时间窗: Up to 30 days after the procedure.
Proportion of participants experiencing at least one of the following within 30 days: (1) post-ERCP pancreatitis (serum lipase ≥3× upper limit of normal plus abdominal pain persisting ≥24 hours requiring prolonged or unplanned hospitalization); (2) clinically significant bleeding (hemoglobin drop ≥2 g/dL and/or need for endoscopic, radiological, or surgical intervention); (3) duodenal or biliary perforation confirmed by imaging or surgery.
次要结局
- Incidence of papillary restenosis requiring re-intervention(From 6 months to 5 years after the procedure)
- Incidence of post-ERCP pancreatitis.(Within 72 hours after the procedure)
- Incidence of duodenal or biliary perforation.(From the start of the procedure up to 30 days after.)
- Incidence of clinically significant post-sphincterotomy bleeding(From the start of the procedure up to 30 days after)
- Rate of cholecystectomy within 12 months(From the date of the procedure up to 12 months)
- Technical success: complete bile duct stone clearance(During the procedure)
- Need for repeat ERCP within 30 days(From the date of the index procedure up to 30 days after)
研究者
Oleg Dovbenko, MD
Head of the Department of Endoscopic Surgery, Military Medical Clinical Center of the Southern Region
Military Medical Clinical Center of the Southern Region, Ukraine