Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Stone fragments clearance
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Stone fragments clearance
Time Frame: 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 Outcomes
- Bleeding(3 months)
- Post-ERCP cholangitis(3 months)
- Perforation(3 months)
- Post-ERCP pancreatitis(3 months)
- The procedure time(3 months)