Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05746832
• Other study ID #: CBD stones managment by ERCP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Zyad Osama Harith, resident
• Phone: 01149863511
• Email: zyadosama200000[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Calculi
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut universty Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of procedure.	This is measured in hours.	On the day of determined procedure.
Primary	Rate of stone size reduction.	This is measured in millimeters.	Baseline.
Primary	Width of CBD.	This is measured in millimeters.	Baseline.
Primary	Degree of stone clearance and complications.	Those are determined by close monitoring of patients whether after ERCP or surgery.	Baseline.
Primary	Postoperative morbidity and mortality.	Those are measures in percentage of patients in the study.	Baseline.
Secondary	Blood loss during the procedure.	This is measured in milliliters.	Baseline.
Secondary	Postoperative wound infection.	This is measured in percentage of patients in the study.	Baseline.
Secondary	Postoperative hospital stay.	This is measured in days.	Baseline.
Secondary	Postoperative hemorrhage.	This is measured in milliliters.	Baseline.
Secondary	Postoperative 30 day mortality rate.	This is measured in percentage of patients in the study.	Baseline.