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

NCT ID: NCT06601387

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Recurrent Common Bile Duct Stones

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

comparative prospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1 of patients

recurrent CBD Stones.

Group Type OTHER

choledochoduodonostomy

Intervention Type PROCEDURE

surgical drainage procedures

group 2 of patients

recurrent CBD stones

Group Type OTHER

hepaticojejunostomy

Intervention Type PROCEDURE

surgical intervention

Interventions

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choledochoduodonostomy

surgical drainage procedures

Intervention Type PROCEDURE

hepaticojejunostomy

surgical intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Ahmed Hassan Aly

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Hassan Aly

Assistant lecturer general surgery department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of medicine Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed Ahmed Hassan, assistant lecturer

Role: CONTACT

+201023858185

Ahmed Mohamed Taha, assistant professor

Role: CONTACT

+201015972104

References

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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.

Reference Type BACKGROUND
PMID: 33304860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36726399 (View on PubMed)

Related Links

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Other Identifiers

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Surgery for common bile duct

Identifier Type: -

Identifier Source: org_study_id