Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

NCT ID: NCT05746832

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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.

Conditions

Common Bile Duct Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Intervention Type: PROCEDURE

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.

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

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Intervention Type: PROCEDURE

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.

Interventions

Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Zyad Osama Harith

Zyad Osama Harith Abulatif (General surgery resident)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisham Ali Ryad, Prof.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut universty Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

Zyad Osama Harith, resident

Role: CONTACT

zyadosama200000@gmail.com

01149863511

Mostafa Mahmoud Mohammed Sayed, ass prof

Role: CONTACT

mostafa.sayed@aun.edu.eg

+201271207839

Other Identifiers

CBD stones managment by ERCP

Identifier Type: -

Identifier Source: org_study_id