Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy

NCT04406961 | Completed

• 2 other identifiers: Protocol-273273
• Study Type: interventional
• Target: 1,521
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Papillary Stenosis; Biliary Obstruction; Gallstone Disease; External Biliary Fistula; Malignant Biliary Obstruction; Benign Biliary Strictures With Current or Prior Biliary Obstruction; Choledocholithiasis

Keywords

endoscopic transpapillary antegrade sphincterotomy (ASD); antegrade sphincterotome; preservation of the function of the sph. of Oddi; avoid cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Standard sphincterotomy.

ACTIVE COMPARATOR

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.; Device: The standard sphincterotome.

Antegrade Sphincterotomy Dovbenko (ASD)

EXPERIMENTAL

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.; Device: The antegrade sphincterotome developed by Dr. Dovbenko.

Interventions

Endoscopic sphincterotomy. PROCEDURE

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.

Standard sphincterotomy.

Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko. PROCEDURE

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.

Also known as: ASD

Antegrade Sphincterotomy Dovbenko (ASD)

The antegrade sphincterotome developed by Dr. Dovbenko. DEVICE

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.

Antegrade Sphincterotomy Dovbenko (ASD)

The standard sphincterotome. DEVICE

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.

Also known as: "pull-type" model, the Erlangen.

Standard sphincterotomy.

Eligibility Criteria

• Age: 18 Years - 102 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Oleg Dovbenko

Odesa, Odesa Oblast, 65044, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 38262462 DERIVED

Related 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

MeSH Terms

Conditions

Choledocholithiasis; Cholelithiasis

Interventions

Sphincterotomy, Endoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Minimally Invasive Surgical Procedures; Sphincterotomy; Myotomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Endoscopic Surgery, Military Medical Clinical Center of the Southern Region

Model Details: This parallel-group, randomized controlled trial compares two endoscopic sphincterotomy techniques in patients undergoing transpapillary interventions: (1) conventional pull-type endoscopic sphincterotomy (EST), and (2) antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD), which selectively incises only the circular muscle layer of the sphincter of Oddi using a dedicated sphincterotome (Ukrainian Patent No. UA 117987C2, 2019). The primary analysis evaluates the relative risk and 95% confidence interval for procedure-related complications, including bleeding, perforation, post-ERCP pancreatitis, and need for cholecystectomy.

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 29, 2020
• Study Start: January 1, 2020
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

UA (1)