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CBD Repair Over T-tube or Primary Repair

NCT ID: NCT04108780

Last Updated: 2019-09-30

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2022-07-30

Brief Summary

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the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Detailed Description

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Common Bile Duct Exploration is a surgery that involves opening the main bile duct that drains from liver and gallbladder into the first part of the small intestine (the duodenum). This is needed when a gallstone drops out of the gallbladder into the duct and partially or completely blocks up the duct. This can cause jaundice , fever and chills, severe abdominal pain due to infection / inflammation of the bile duct, gallbladder or pancreas. This most often involves admission to the hospital and urgent intervention. Most commonly, a procedure called an ERCP is used to clear out the stones from the bile duct. If gallbladder will have to be removed soon to prevent this potentially serious condition from occurring again.

During the operation the investigators remove gallbladder then a duct exploration is performed. This involves opening the duct directly and removing the stones.

Prior to Common Bile Duct Exploration surgery, patient will be asked not to eat anything after midnight prior to the surgery. patient will be given specific instructions from the surgeon or anesthesiologist about which medications he should or should not take prior to the surgery. patient should not take any blood thinning medications at least 5 days prior to your operation. This should be discussed with the surgeon at the preop visit.

Conditions

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CBD Exploration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CBD exploration with T-tube

repair of CBD after CBD exploration over T-tube

T-tube

Intervention Type DEVICE

T shaped tube used as stent after CBD exploration

CBD exploration with primary repair

primary repair of CBD after CBD exploration

T-tube

Intervention Type DEVICE

T shaped tube used as stent after CBD exploration

Interventions

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T-tube

T shaped tube used as stent after CBD exploration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergo common bile duct exploration

Exclusion Criteria

* patients who has failed ERCP for management of common bile duct exploration
* CBD diameter 2 cm or more
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Aboelhassan Mohamed Hassanein

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mhamed Abo Elhassan, Master

Role: CONTACT

Phone: +201001311044

Email: [email protected]

References

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Wu X, Huang ZJ, Zhong JY, Ran YH, Ma ML, Zhang HW. Laparoscopic common bile duct exploration with primary closure is safe for management of choledocholithiasis in elderly patients. Hepatobiliary Pancreat Dis Int. 2019 Dec;18(6):557-561. doi: 10.1016/j.hbpd.2019.07.005. Epub 2019 Jul 25.

Reference Type BACKGROUND
PMID: 31474445 (View on PubMed)

Guan H, Jiang G, Mao X. Primary duct closure combined with transcystic drainage versus T-tube drainage after laparoscopic choledochotomy. ANZ J Surg. 2019 Jul;89(7-8):885-888. doi: 10.1111/ans.15163. Epub 2019 May 8.

Reference Type BACKGROUND
PMID: 31067598 (View on PubMed)

Jiang C, Zhao X, Cheng S. T-Tube Use After Laparoscopic Common Bile Duct Exploration. JSLS. 2019 Jan-Mar;23(1):e2018.00077. doi: 10.4293/JSLS.2018.00077.

Reference Type BACKGROUND
PMID: 30675097 (View on PubMed)

Other Identifiers

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CBD exploration

Identifier Type: -

Identifier Source: org_study_id