Laparoscopic Cholodochotomy in Management of CBD Stones

NCT ID: NCT06514911

Last Updated: 2025-06-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-06-25

Brief Summary

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The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.

Detailed Description

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Conditions

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Management of CBD Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary closure following Laparoscopic cholodochotomy in management of CBD stones

Group Type ACTIVE_COMPARATOR

primary closure following Laparoscopic cholodochotomy in management of CBD stones

Intervention Type PROCEDURE

primary closure of cholodochotomy incision in laparoscopic CBD exploration avoiding T-tube insertion

T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones

Group Type ACTIVE_COMPARATOR

T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones

Intervention Type PROCEDURE

drainage of bile by T-tube insertion in laparpscopic CBD exploration

Interventions

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primary closure following Laparoscopic cholodochotomy in management of CBD stones

primary closure of cholodochotomy incision in laparoscopic CBD exploration avoiding T-tube insertion

Intervention Type PROCEDURE

T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones

drainage of bile by T-tube insertion in laparpscopic CBD exploration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. patients with a definitive preoperative diagnosed with CBD stones.
2. a CBD diameter of ≥1 cm.
3. patients are fit for surgery

Exclusion Criteria

1. patients with liver cirrhosis.
2. a CBD diameter of \<1 cm
3. malignancy in the biliary tract or CBD stricture .
4. patients are not fit for surgery.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Islam Khalaf Mohamed

Resident, Department of General Surgery, Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eslam K Mohamed, Resident

Role: CONTACT

01004085866

alaa el-din H Mohamed, Professor

Role: CONTACT

01069227827

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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Cianci P, Restini E. Management of cholelithiasis with choledocholithiasis: Endoscopic and surgical approaches. World J Gastroenterol. 2021 Jul 28;27(28):4536-4554. doi: 10.3748/wjg.v27.i28.4536.

Reference Type BACKGROUND
PMID: 34366622 (View on PubMed)

Tan D, Zhang Y. Differences in Outcome and Comparison of Stress and Immune Status in Patients with Recurrent Common Bile Duct Stones after Biliary Tract Surgery Choosing Three Procedures (ERCP, OCBDE, and LCBDE) for Treatment. Comput Math Methods Med. 2022 Jan 5;2022:9197990. doi: 10.1155/2022/9197990. eCollection 2022.

Reference Type BACKGROUND
PMID: 35035527 (View on PubMed)

Hua J, Lin S, Qian D, He Z, Zhang T, Song Z. Primary closure and rate of bile leak following laparoscopic common bile duct exploration via choledochotomy. Dig Surg. 2015;32(1):1-8. doi: 10.1159/000368326. Epub 2015 Jan 22.

Reference Type BACKGROUND
PMID: 25613528 (View on PubMed)

Other Identifiers

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Soh-Med-24-06-25MS

Identifier Type: -

Identifier Source: org_study_id

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