Clinical trial NCT06601387: Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Paients with Choledocholithiasis Indicated for Shunt.
Official title: Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients with Choledocholithiasis Indicated for Shunt .
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recurrent Common Bile Duct Stones
Keywords: Choledochoduodonostomy
Hepaticojejunostomy
Choledocholithiasis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative prospective study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

residual stones. recurrent stones, failed ERCP due to imacted large stone, Multiple CBD calculi with distal narrowing (Funnel syndrome), Papillary stenosis; impacted calculi, Biliary sludge-symptomatic, Sphincter of Oddi dysfunction/stenosis, Primary CBD stones; previous choledochotomy and Marked CBD dilatation.

Exclusion Criteria:

surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.

Primary outcomes:
measure: primary outcome measure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut university
Study officials:
References:
citation: Park CY, Choi SH, Kwon CI, Cho JH, Jang SI, Lee TH, Han JH, Jeong S, Ko KH. What is the better surgical treatment option for recurrent common bile duct stones? Ann Surg Treat Res. 2020 Dec;99(6):329-336. doi: 10.4174/astr.2020.99.6.329. Epub 2020 Nov 26.
citation: Xia H, Zhang H, Xin X, Liang B, Yang T, Liu Y, Wang J, Meng X. Surgical Management of Recurrence of Primary Intrahepatic Bile Duct Stones. Can J Gastroenterol Hepatol. 2023 Jan 23;2023:5158580. doi: 10.1155/2023/5158580. eCollection 2023.