Trials / Completed

CompletedNCT04406961

Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy

A Randomized Controlled Trial Comparing Antegrade Sphincterotomy Dovbenko (ASD) With Conventional Pull-Type Sphincterotomy in Patients Undergoing ERCP

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 1,521 (actual)

Sponsor: Military Medical Clinical Center of the Southern Region, Ukraine · Academic / Other
Sex: All
Age: 18 Years – 102 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.	Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla.
DEVICE	The antegrade sphincterotome developed by Dr. Dovbenko.	A device is represented by a teflon catheter in the distal part of which a double tube of variable shape is created. The proximal part of the ASD sphincterotome consists of a handle, and a metal wire is located inside the teflon catheter for connection to an electrosurgical unit. On the distal part, the teflon catheter is formed of a double tube length is 10 to 35 mm. The metal wire exits the catheter at a distance 10 to 35 mm from the tip and enters into the tip the second teflon tube. The distal part of the knife is formed shape a hook. A metal cutting wire is located between two tubes. Moving the handle the metal wire is shifted. Pushing the metal wire or approaching in the distal part the second tube sets the depth of cut. The incision is made by moving on guidewire in bile duct. The power settings vary.
PROCEDURE	Endoscopic sphincterotomy.	Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct.
DEVICE	The standard sphincterotome.	The standard sphincterotome, the Erlangen "pull-type" model, consists of a catheter containing a cautery wire exposed 15 to 25 mm near the tip of the instrument. The leading tip distal to the wire, the "nose," is 5 to 10 mm in diameter. After deep bile duct cannulation, the sphincterotome is retracted slowly, until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made by lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary.

Timeline

Start date: 2020-01-01
Primary completion: 2024-12-21
Completion: 2025-12-21
First posted: 2020-05-29
Last updated: 2026-01-07

Locations

1 site across 1 country: Ukraine

Source: ClinicalTrials.gov record NCT04406961. Inclusion in this directory is not an endorsement.