Clinical trial NCT03701009: Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stone Clearance
Keywords: ERCP
Common bile duct stone
Cholangitis
Residual stone
Irrigation
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

Detailed description: In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(\>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.

Eligibility criteria: Inclusion Criteria:

* ERCP common bile duct stone patients were able to provide written informed consent;
* Size of stone large than 1.2 cm.

Exclusion Criteria:

* Unwillingness or inability to consent for the study;
* Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count (\<50×10\^9 / L) or using anti-coagulation drugs;
* Previous ERCP;
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, 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;
* Presence of intrahepatic duct stone;
* Malignancy.

Primary outcomes:
measure: Stone fragments clearance
timeFrame: 3 months
Secondary outcomes:
measure: Post-ERCP cholangitis
timeFrame: 3 months
measure: Bleeding
timeFrame: 3 months
measure: Post-ERCP pancreatitis
timeFrame: 3 months
measure: Perforation
timeFrame: 3 months
measure: The procedure time
timeFrame: 3 months
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: Xun Li, MD,PhD
role: STUDY_DIRECTOR
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: Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.