Viewing Study NCT06601387



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06601387
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-06

Brief Title: Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Paients with Choledocholithiasis Indicated for Shunt
Sponsor: None
Organization: None

Study Overview

Official Title: Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients with Choledocholithiasis Indicated for Shunt
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A biliary-enteric anastomosis can be needed for a number of indications including malignant or pre-malignant biliary diseases benign biliary stenosis bile duct injury and complex choledocholithiasis Choledochoduodenostomy is the most simple form of biliary-digestive anastomosis with only minimal alteration to the normal anatomy Due to the reported specific complications of choledochoduodenostomy such as sump syndrome and gastritis caused by biliary reflux creation of a HJ was preferred in the past decades A Roux-en-Y hepaticojejunostomy HJ does not cause sump syndrome and only rarely reflux gastritis but the procedure is more extensive requiring an additional jejuno-jejunostomy Especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections the creation of a Roux-en-Y limb might pose a problem Some recent publications have concluded that CD leads to acceptable surgical outcome with low reported incidences of sump syndrome and reflux gastritis However these studies do not make a direct comparison between CD and HJ Especially comparisons of long-term outcomes between CD and HJ are lacking
Detailed Description: There are 2 options are available Choledochoduodonostomy or Roux-en-Y choledochojejunostomy Both can be accomplished via a laparoscopic approach however thereis no consensus to which is best due to a paucity of data comparing the techniques

Choice of operation is largely left up to the individual surgeon Athough performed infrequently for benign biliary disease biliary bypass operations are fundamental for any surgeon and are considered a core operation by the American College of Surgeons for any general surgery resident In our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis

Study Oversight

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