Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy (ASD)

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

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.

Study Overview

• Status: Completed
• Conditions: Choledocholithiasis; Malignant Biliary Obstruction; Biliary Obstruction; Gallstone Disease; Benign Biliary Strictures With Current or Prior Biliary Obstruction; Papillary Stenosis; External Biliary Fistula
• Intervention / Treatment: Procedure: Endoscopic sphincterotomy.; Device: The standard sphincterotome.; Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.; Device: The antegrade sphincterotome developed by Dr. Dovbenko.

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.

• Study Type: Interventional
• Enrollment (Actual): 1521
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Odesa Oblast
    • Odesa, Odesa Oblast, Ukraine, 65044
      • Oleg Dovbenko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 102 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard sphincterotomy.; Patients in this group underwent conventional retrograde endoscopic sphincterotomy using a standard Erlangen-type "pull" sphincterotome. Following deep biliary cannulation, the sphincterotome was used to perform a standard pull-type incision across the major duodenal papilla. In 20% of cases, a needle-knife precut papillotomy was performed to facilitate biliary access. A total of 760 patients were enrolled in this arm. Procedure-related complications were prospectively recorded, including: post-ERCP pancreatitis, bleeding, perforation, cholangitis, acute cholecystitis, recurrent choledocholithiasis, and papillary restenosis.	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.; Other Names: "pull-type" model, the Erlangen.
Experimental: Antegrade Sphincterotomy Dovbenko (ASD); Patients underwent endoscopic transpapillary antegrade sphincterotomy (Antegrade Sphincterotomy Dovbenko, ASD) using a dedicated sphincterotome designed by Dr. Dovbenko (Ukrainian Patent No. UA 117987C2, 2019). Following deep biliary cannulation, the sphincterotome was advanced transpapillary and used to perform an antegrade incision selectively targeting only the circular muscle layer of the sphincter of Oddi, with preservation of the longitudinal layer and duodenal integrity. In 20% of cases, needle-knife precut papillotomy was performed to facilitate initial biliary cannulation.	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.; Other Names: ASD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite incidence of major procedure-related adverse events	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.	Up to 30 days after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of papillary restenosis requiring re-intervention	Papillary restenosis is defined as recurrent biliary obstruction confirmed by imaging (CT, MRI, or cholangiography), characterized by: common bile duct diameter >11 mm, and; total bilirubin >60 µmol/L (≈3.5 mg/dL) in the absence of other causes of obstruction. Only cases requiring endoscopic, radiological, or surgical re-intervention are counted as events.	From 6 months to 5 years after the procedure
Incidence of post-ERCP pancreatitis.	Post-ERCP pancreatitis is defined as new-onset abdominal pain persisting for at least 24 hours plus serum lipase level at least 3 times the upper limit of normal, requiring prolonged or unplanned hospitalization for pain management and monitoring.	Within 72 hours after the procedure
Incidence of duodenal or biliary perforation.	Perforation is defined as a full-thickness defect of the duodenal or bile duct wall, confirmed by: (1) extraluminal contrast on cholangiography or fluoroscopy, (2) free air on abdominal X-ray or CT scan, or (3) intraoperative diagnosis. Perforations are classified as periampullary, duodenal, or biliary.	From the start of the procedure up to 30 days after.
Incidence of clinically significant post-sphincterotomy bleeding	Clinically significant bleeding is defined as: (1) a decrease in hemoglobin level of ≥2 g/dL from pre-procedure baseline, and/or (2) requirement for endoscopic, radiological, or surgical intervention to achieve hemostasis. Minor oozing not requiring intervention is not counted as an event.	From the start of the procedure up to 30 days after
Rate of cholecystectomy within 12 months	Proportion of participants with concomitant gallstone disease who undergo cholecystectomy within 12 months following the index ERCP procedure, regardless of symptoms. Only elective or urgent cholecystectomies performed for biliary pathology are included; procedures for unrelated indications are excluded.	From the date of the procedure up to 12 months
Technical success: complete bile duct stone clearance	Defined as the absence of residual filling defects in the common bile duct on post-procedure cholangiography (intraoperative or fluoroscopic). Clearance is confirmed before the end of the index ERCP session.	During the procedure
Need for repeat ERCP within 30 days	Proportion of participants requiring a repeat endoscopic retrograde cholangiopancreatography (ERCP) within 30 days after the index procedure due to: (1) incomplete stone clearance, (2) recurrent biliary obstruction, (3) post-procedure complications (e.g., cholangitis, bleeding, or stent dysfunction), or (4) other biliary or pancreatic indications directly related to the initial intervention. Elective ERCP for unrelated reasons is excluded.	From the date of the index procedure up to 30 days after

Collaborators and Investigators

• Sponsor: Military Medical Clinical Center of the Southern Region, Ukraine

Publications and helpful links

General Publications

• Dovbenko O, Herasymenko O. Endoscopic management of hepaticojejunal anastomosis fistula after Whipple's resection. Endoscopy. 2024 Dec;56(S 01):E72-E73. doi: 10.1055/a-2226-0276. Epub 2024 Jan 23. No abstract available.

Helpful Links

• Endoscopic transpapillary antegrade sphincterotomy (ASD): preliminary results. Endoscopy 2019;51(S 04):S192. Abstract presented at ESGE Days 2019, Prague.
• Diathermic knife and method of endoscopic transpapillary antegrade sphincterotomy developed by Dr. O.V. Dovbenko. Ukrainian Patent UA117987C2, issued 2018

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 21, 2024
• Study Completion (Actual): December 21, 2025

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: endoscopic transpapillary antegrade sphincterotomy (ASD); antegrade sphincterotome; preservation of the function of the sph. of Oddi; avoid cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Choledocholithiasis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Digestive System Surgical Procedures; Biliary Tract Surgical Procedures; Myotomy; Sphincterotomy; Sphincterotomy, Endoscopic
• Other Study ID Numbers: Protocol-273; 273 (Other Identifier: Bioethics Committee of the National Academy of Sciences of Ukraine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) collected during the trial, including de-identified baseline characteristics, procedural details, outcomes, and adverse events, will be available.
• IPD Sharing Time Frame: IPD and supporting documents will be available beginning 3 months after publication of the primary results manuscript and will remain accessible for 5 years.
• IPD Sharing Access Criteria: Researchers may request access to de-identified IPD for non-commercial, scientifically valid research purposes. Requests must be submitted in writing to the Principal Investigator and will be reviewed by the Data Access Committee. Approved researchers will sign a data use agreement ensuring confidentiality and prohibiting re-identification.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No