Viewing Study NCT05746832



Ignite Creation Date: 2024-05-06 @ 6:41 PM
Last Modification Date: 2024-10-26 @ 2:52 PM
Study NCT ID: NCT05746832
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-01-31
First Post: 2021-11-01

Brief Title: Failed Retrograde Cholangiopancreatography ERCP Stone Extraction Surgical Interference
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Failed Retrograde Cholangiopancreatography ERCP Stone Extraction Surgical Interference Versus Follow up on Stent
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None