Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746832

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Calculi	Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Active Comparator: 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.

Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 hospital stay. [Baseline.]
This is measured in days.
Postoperative hemorrhage. [Baseline.]
This is measured in milliliters.
Postoperative 30 day mortality rate. [Baseline.]
This is measured in percentage of patients in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut universty Hospital	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Hisham Ali Ryad, Prof., Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zyad Osama Harith, Zyad Osama Harith Abulatif (General surgery resident), Assiut University

ClinicalTrials.gov Identifier:

NCT05746832

Other Study ID Numbers:

CBD stones managment by ERCP

First Posted:

Feb 28, 2023

Last Update Posted:

Feb 28, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gallstones

Calculi

Study Results

No Results Posted as of Feb 28, 2023