Management of CBD StonesNCT06514911
Laparoscopic Cholodochotomy in Management of CBD Stones
A study testing primary closure following Laparoscopic cholodochotomy in management of CBD stones and T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones in people with Management of CBD Stones, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Management of CBD Stones
- What is being tested?
- primary closure following Laparoscopic cholodochotomy in management of CBD stones and T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a definitive preoperative diagnosed with CBD stones.
- a CBD diameter of ≥1 cm.
- patients are fit for surgery
Who cannot join
- patients with liver cirrhosis.
- a CBD diameter of <1 cm
- malignancy in the biliary tract or CBD stricture .
- patients are not fit for surgery.
Trial locations and contacts
1 site in 1 country.
alaa el-din H Mohamed, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Primary Closure Versus T-tube Drainage Following Laparoscopic Cholodochotomy in Management of CBD Stones
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.
- Conditions
- Management of CBD Stones
- Being tested
- primary closure following Laparoscopic cholodochotomy in management of CBD stones, T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary closure following Laparoscopic cholodochotomy in management of CBD stonesProcedure or surgery
primary closure of cholodochotomy incision in laparoscopic CBD exploration avoiding T-tube insertion
T-tube drainage following Laparoscopic cholodochotomy in management of CBD stonesProcedure or surgery
drainage of bile by T-tube insertion in laparpscopic CBD exploration
| Study group | Role | What they receive |
|---|---|---|
| primary closure following Laparoscopic cholodochotomy in management of CBD stones | Active comparator | Not described Receives: Procedure: primary closure following Laparoscopic cholodochotomy in management of CBD stones |
| T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones | Active comparator | Not described Receives: Procedure: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary leakage in the management of CBD stones
peritoneal collection of bile after common bile duct exploration
Measured: 3 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start10 Jun 2024
- Primary completion25 Jun 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Management of CBD StonesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Khalaf Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514911
- Sponsor's protocol ID
- Soh-Med-24-06-25MS
- Status last verified
- Jun 2024
- First submitted
- 17 Jul 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34366622Tan 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.
PubMed 35035527Hua 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.
PubMed 25613528
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Closure Versus T-tube Drainage Following Laparoscopic Cholodochotomy in Management of CBD Stones
- ClinicalTrials.gov ID
- NCT06514911
- Acronym / sponsor ID
- Soh-Med-24-06-25MS
- Conditions
- Management of CBD Stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary closure following Laparoscopic cholodochotomy in management of CBD stones | Active comparator | Procedure: primary closure following Laparoscopic cholodochotomy in management of CBD stones |
| T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones | Active comparator | Procedure: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a definitive preoperative diagnosed with CBD stones.
- a CBD diameter of ≥1 cm.
- patients are fit for surgery
Key exclusion criteria (4 listed)
- patients with liver cirrhosis.
- a CBD diameter of <1 cm
- malignancy in the biliary tract or CBD stricture .
- patients are not fit for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary closure following Laparoscopic cholodochotomy in management of CBD stonesprimary closure of cholodochotomy incision in laparoscopic CBD exploration avoiding T-tube insertion | Procedure or surgery | primary closure following Laparoscopic cholodochotomy in management of CBD stones |
| T-tube drainage following Laparoscopic cholodochotomy in management of CBD stonesdrainage of bile by T-tube insertion in laparpscopic CBD exploration | Procedure or surgery | T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones |
Primary outcome
biliary leakage in the management of CBD stones
Time frame: 3 days after the operation
peritoneal collection of bile after common bile duct exploration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 34366622Cianci 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.
- Background: PubMed 35035527Tan 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.
- Background: PubMed 25613528Hua 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alaa el-din H Mohamed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary closure following Laparoscopic cholodochotomy in management of CBD stones and T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones in people with Management of CBD Stones, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam K Mohamed, Resident (01004085866, eslamdahab330@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biliary leakage in the management of CBD stones (time frame: 3 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.