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Not yet recruiting NCT06601387

Evaluation of Choledochoduodonostomy vs Hepaticojejunostomy in Paients With Choledocholithiasis Indicated for Shunt.

No phase Interventional Recurrent Common Bile Duct Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: choledochoduodonostomy, hepaticojejunostomy.
Who it may be relevant to
Registry conditions: Recurrent Common Bile Duct Stones. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients With Choledocholithiasis Indicated for Shunt .

Overview

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.

Interventions

  • Procedure choledochoduodonostomy
    surgical drainage procedures
  • Procedure hepaticojejunostomy
    surgical intervention

Primary outcome measures

  • primary outcome measure [Time frame: one year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of medicine Assiut university — Asyut

Publications

  • 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. PMID 33304860
  • 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. PMID 36726399

Identifiers

NCT: NCT06601387 · Surgery for common bile duct

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗