Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy

Military Medical Clinical Center of the Southern Region, Ukraine

Status: Completed

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

Treatments: Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.; Procedure: Endoscopic sphincterotomy.; Device: The standard sphincterotome.; Device: The antegrade sphincterotome developed by Dr. Dovbenko.

Study type: Interventional

Funder types: Other

Identifiers

NCT04406961

273

Protocol-273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,521 patients

Sex: All

Ages: 18 to 102 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,521 participants in 2 patient groups

Standard sphincterotomy.

Active Comparator group

Description:

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.

Treatment:

Device: The standard sphincterotome.

Procedure: Endoscopic sphincterotomy.

Antegrade Sphincterotomy Dovbenko (ASD)

Experimental group

Description:

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.

Treatment:

Device: The antegrade sphincterotome developed by Dr. Dovbenko.

Procedure: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.