Clinical trial NCT04108780: CBD Repair Over T-tube or Primary Repair
Official title: Comparative Study : Repair of Common Bile Duct After CBD Exploration Over T-tube or Primary Repair Without Tube
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CBD Exploration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient who will undergo CBD exploration for management of CBD stone

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: bile leak from common bile duct
timeFrame: baseline
Secondary outcomes:
measure: hospital stay length
timeFrame: base line
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.