CClinicalTrials.gg
Status unknownNCT04108780Updated Sep 30, 2019

CBD Repair Over T-tube or Primary Repair

An observational study in CBD Exploration, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • CBD Exploration
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patient who will undergo CBD exploration for management of CBD stone

Inclusion criteria

  • Patients who will undergo common bile duct exploration

Exclusion criteria

Exclusion Criteria:

  • patients who has failed ERCP for management of common bile duct exploration
  • CBD diameter 2 cm or more
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • CBD exploration with T-tube

    repair of CBD after CBD exploration over T-tube

    Device: T-tube

  • CBD exploration with primary repair

    primary repair of CBD after CBD exploration

    Device: T-tube

Interventions

  • DeviceT-tube

    T shaped tube used as stent after CBD exploration

06

What researchers measure

Primary outcomes

  1. bile leak from common bile duct

    Assessment which type of repair (with T-tube or primary repair) bile leak will occurs more

    Time frame: baseline

Secondary outcomes

  1. hospital stay length

    Assessment which type of repair (with T-tube or primary repair) patient will stay in the hospital more after CBD exploration

    Time frame: base line

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31474445 ↗
  • 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. PubMed 31067598 ↗
  • 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. PubMed 30675097 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04108780
Lead sponsor
Assiut University
Responsible party
Mohamed Aboelhassan Mohamed Hassanein (doctor, Assiut University) — Principal investigator
First posted
Sep 30, 2019
Start date
Sep 25, 2019 (estimated)
Primary completion
Mar 30, 2022 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Sep 30, 2019

Study contacts

Mhamed Abo Elhassan, Master
Contact
doctor_200799@yahoo.com
+201001311044

Oversight

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 2019. You cannot join it, but the record below documents what was studied.

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