Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758923
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-02-17
First Post:
2020-09-20
Brief Title:
Management for Concomitant Gallstones and Common Bile Duct Stones
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Single-stage Versus Two-staged Management for Concomitant Gallstones and Common Bile Duct Stones
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
NOT_YET_RECRUITING
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:
Choledocholithiasis is identified in approximately 3-10 of patients with cholelithiasis 1-3 While laparoscopic cholecystectomy LC is considered the treatment of choice in patients with gall bladder stones there is a debate about the management of common bile duct CBD stones 4 and this has led to a range of therapeutic strategies for the management of concomitant gallstones and CBD stones patients Two-stage endoscopic management using endoscopic retrograde cholangiopancreatography ERCP followed by laparoscopic cholecystectomy is a common approach although single-stage management by laparoscopic cholecystectomy with surgical exploration of the CBD is an alternative with the single-stage approach more common in the open surgery era Currently it is unclear whether two-stage management is better than or at least equivalent to the single-stage surgical approach to choledocholithiasis To address this we undertook this study to compare these two approaches The aim of this prospective randomized trial was to determine the best technique for the management of patients with concomitant gallstones and common bile duct stones by comparing the success rate complication rates and longer-term follow-up outcomes
Detailed Description:
Single stage approach Under General anaesthesia a5 trocar method will be used to access the abdominal cavity Aconventional approach to laparoscopic cholecystectomy will be first udertaken with dissection of calots triangle The cystic duct will be pulled laterally to facilitate exposure of the anterior wall of the CBDand the CBD will be opened longitudinally for adistance of approximately 1to15 cm using laparoscopic scissors A5mm flexible choledoscope will be used to identify the CBD stones which will be removed by flushing sterile saline passingastone basket or electrohydraulic lithotrpsy as necessary to clear the CBD A T-tube will be inserted into the CBD via the choledochotomy which will be closed by interrupted resorbable sutures before completing the cholecystectomy Cholangiography throuh T-tube be performed 14 14 days later and the T-tube will be removed immediately after Cholangiography if no residual CBD stones is identified If residual stones are found then will be removed through the T-tube track using A choledoscope Two-stage approach The treatment process commenced with intial endoscopic treatment phase This will be udertaken Under General anaesthesia and entailed ERCP and endoscopic sphincterectomy The CBD stones will be removed using a basket or ballon with lithotrpsy added if necessary An endoscopic nasobiliary drainge will be inserted and kept in place until after laparoscopic cholecystectomy which perfermed 2 to 5 days later depending on the patients s condition Surgery will be delsyed if urine amylase is elevated or significant abdominal pain is present 2 to 5 days after the operation Cholangiography will be performed via endoscopic nasobiliary drainge tube And the endoscopic nasobiliary drainge tube wii be removed if no residual CBD stones are seen
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