Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Assiut University

Status: Not yet enrolling

Conditions: Common Bile Duct Calculi

Treatments: Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05746832

CBD stones managment by ERCP

Details and patient eligibility

About

Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Full description

Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.

Enrollment: 3 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. All cases of difficult common bile duct stones leading to variable occlusion.
2. Patients fit for intervention.
3. Patients informed consent for study.

Exclusion criteria

1. Surgically unfit cases according to ASA
2. Locally advanced irresectable cases.
3. Patients refuse consent to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

One session application of (ERCP) in the management of common bile duct stones.

Active Comparator group

Description:

One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Treatment:

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Two sessions application of (ERCP) in the management of common bile duct stones.

Active Comparator group

Description:

Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Treatment:

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)