NCT05746832

Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-02-28
• Last updated: 2024-01-31

Locations

1 site across 1 country: Egypt