Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04758923 |
| Other study ID # |
Assuit university hospital.. |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
February 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 calot's 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 1to1.5 cm using laparoscopic scissors. A5mm flexible
choledoscope will be used to identify the CBD stone(s) 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.
