Clinical trial NCT05639816: Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Official title: Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Calculi
Keywords: endoscopic retrograde cholangiopancreatography
endoscopic ultrasound
cholangitis
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2022-12-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Included patients are randomized to two group, study group and control group an followed up parallelly.
Primary purpose: TREATMENT

Brief summary: Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.

Detailed description: This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. One arm received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as control. Both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.

Eligibility criteria: Inclusion Criteria:

* Patients with common bile duct stone
* Complete stone removal by endoscopy as seen in occluded cholangiogram

Exclusion Criteria:

* unstable vital sign
* failed complete stone remval
* assciated biliary malignancy or history of bile duct surgery
* associated bile duct stricture or choledochal cyst
* Toxic cholangitis
* pregnancy or unable to give informed consent

Primary outcomes:
measure: prevalence of residual CBD stone
timeFrame: 1 day
Secondary outcomes:
measure: factors associated with retained CBD stone
timeFrame: 1 day
measure: Complicaion and clinical outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
citation: Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.
citation: Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.