Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Not Applicable

Not yet recruiting

• Conditions: Common Bile Duct Calculi
• Interventions: Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

• Registration Number: NCT05746832
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Study Start: 2024-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two sessions application of (ERCP) in the management of common bile duct stones.	Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)	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.
One session application of (ERCP) in the management of common bile duct stones.	Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)	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.

Primary Outcome Measures

Name	Time	Method
Width of CBD.	Baseline.	This is measured in millimeters.
Degree of stone clearance and complications.	Baseline.	Those are determined by close monitoring of patients whether after ERCP or surgery.
Postoperative morbidity and mortality.	Baseline.	Those are measures in percentage of patients in the study.
Time of procedure.	On the day of determined procedure.	This is measured in hours.
Rate of stone size reduction.	Baseline.	This is measured in millimeters.

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay.	Baseline.	This is measured in days.
Postoperative hemorrhage.	Baseline.	This is measured in milliliters.
Blood loss during the procedure.	Baseline.	This is measured in milliliters.
Postoperative wound infection.	Baseline.	This is measured in percentage of patients in the study.
Postoperative 30 day mortality rate.	Baseline.	This is measured in percentage of patients in the study.

Trial Locations

Locations (1)

Assiut universty Hospital; 🇪🇬 Assiut, Egypt