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

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Stone Clearance

Treatments: Procedure: Saline 50ml; Procedure: Saline +50ml; Procedure: CBD stone removal via lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03701009

Saline irrigation in ERCP

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Stone removal (Saline 50ml each time)

Other group

Description:

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.

Treatment:

Procedure: Saline 50ml

Procedure: CBD stone removal via lithotripsy

Procedure: Saline +50ml