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Status unknownNCT06601387Updated Dec 3, 2024

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

An interventional study of choledochoduodonostomy and hepaticojejunostomy in Recurrent Common Bile Duct Stones, sponsored by Mohamed Ahmed Hassan Aly. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Mohamed Ahmed Hassan Aly · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Common Bile Duct Stones

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Keywords

  • Choledochoduodonostomy
  • Hepaticojejunostomy
  • Choledocholithiasis
03

In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

This is the only study on the registry with Mohamed Ahmed Hassan Aly as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    group 1 of patients

    recurrent CBD Stones.

    Procedure: choledochoduodonostomy

  • Other
    group 2 of patients

    recurrent CBD stones

    Procedure: hepaticojejunostomy

Interventions

  • Procedurecholedochoduodonostomy

    surgical drainage procedures

  • Procedurehepaticojejunostomy

    surgical intervention

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What researchers measure

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)

    Time frame: one year

07

Study locations

1 site
  • Faculty of medicine Assiut university
    Asyut, Egypt
08

References and documents

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. PubMed 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. PubMed 36726399 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06601387
Lead sponsor
Mohamed Ahmed Hassan Aly
Responsible party
Mohamed Ahmed Hassan Aly (Assistant lecturer general surgery department, Assiut University) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Dec 10, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Dec 3, 2024

Study contacts

Mohamed Ahmed Hassan, assistant lecturer
Contact
mouhmed.ahmed@gmail.com
+201023858185
Ahmed Mohamed Taha, assistant professor
Contact
ahmed_taha@aun.edu.eg
+201015972104

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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