Clinical trial NCT03937037: Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Official title: Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stone - Biliary
Keywords: ERCP
Common bile duct stone
Cholangitis
Residual stone
Irrigation
Recurrence
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

Detailed description: In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.

The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.

Eligibility criteria: Inclusion Criteria:

* With ERCP indications
* With mechanical lithotripsy during operation

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Unstable vital signs
* Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock
* Biliary-duodenal fistula confirmed during ERCP
* Pregnant women or breastfeeding

Primary outcomes:
measure: Number of Participants with Recurrence of CBD Stones
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants with Cholangitis
timeFrame: 3 years
measure: Number of Participants with Pancreatitis
timeFrame: 3 years
measure: Number of Participants with Bleeding
timeFrame: 1 month
measure: Number of Participants with Perforation
timeFrame: 1 month
measure: Procedure time of each case
timeFrame: 7 days
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.