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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Common Bile Duct Stones
• Intervention / Treatment: Procedure: choledochoduodonostomy; Procedure: hepaticojejunostomy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ahmed Hassan, assistant lecturer; Phone Number: +201023858185; Email: mouhmed.ahmed@gmail.com
• Study Contact Backup: Name: Ahmed Mohamed Taha, assistant professor; Phone Number: +201015972104; Email: ahmed_taha@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1 of patients; recurrent CBD Stones.	Procedure: choledochoduodonostomy; surgical drainage procedures
Other: group 2 of patients; recurrent CBD stones	Procedure: hepaticojejunostomy; surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mohamed Ahmed Hassan Aly

Publications and helpful links

General 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Choledocholithiasis; Hepaticojejunostomy; Choledochoduodonostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Choledocholithiasis
• Other Study ID Numbers: Surgery for common bile duct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No