Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Paients with Choledocholithiasis Indicated for Shunt.

NCT06601387 | Not Yet Recruiting DMC

• 1 other identifier: Surgery for common bile duct
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Common Bile Duct Stones

Keywords

Choledochoduodonostomy; Hepaticojejunostomy; Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• primary outcome measure

  Abd pain according to pain score from 1 to 10. total billirubin more than 1.2 mg/dl. Fever (temperature more than 38° c)

  one year

Study Arms (2)

group 1 of patients

OTHER

recurrent CBD Stones.

Procedure: choledochoduodonostomy

group 2 of patients

OTHER

recurrent CBD stones

Procedure: hepaticojejunostomy

Interventions

choledochoduodonostomy PROCEDURE

surgical drainage procedures

group 1 of patients

hepaticojejunostomy PROCEDURE

surgical intervention

group 2 of patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mohamed Ahmed Hassan Aly: lead

Study Sites (1)

Faculty of medicine Assiut university

Asyut, Egypt

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Central Study Contacts

Mohamed Ahmed Hassan, assistant lecturer

CONTACT

+201023858185; mouhmed.ahmed@gmail.com

Ahmed Mohamed Taha, assistant professor

CONTACT

+201015972104; ahmed_taha@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer general surgery department

Model Details: comparative prospective study

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 10, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)