Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Not Applicable

Completed

• Conditions: Stone Clearance
• Interventions: Procedure: CBD stone removal via lithotripsy; Procedure: Saline 50ml; Procedure: Saline +50ml

• Registration Number: NCT03701009
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Timeline

• Study First Submitted: 2018-10-06
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Study Start: 2018-10-10
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stone removal (Saline 50ml each time)	CBD stone removal via lithotripsy	After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.
Stone removal (Saline 50ml each time)	Saline 50ml	After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.
Stone removal (Saline 50ml each time)	Saline +50ml	After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.

Primary Outcome Measures

Name	Time	Method
Stone fragments clearance	3 months	Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.

Secondary Outcome Measures

Name	Time	Method
Bleeding	3 months	Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level \>2 g/dl.
Post-ERCP cholangitis	3 months	Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections.
Perforation	3 months	Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
Post-ERCP pancreatitis	3 months	Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure.
The procedure time	3 months	Was defined as the sum of times of all processes of endoscopic procedure.

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China