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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2020-07-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stone Clearance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stone removal (Saline 50ml each time)

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.

Group Type OTHER

CBD stone removal via lithotripsy

Intervention Type PROCEDURE

Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.

Saline 50ml

Intervention Type PROCEDURE

If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.

Saline +50ml

Intervention Type PROCEDURE

If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.

Interventions

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CBD stone removal via lithotripsy

Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.

Intervention Type PROCEDURE

Saline 50ml

If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.

Intervention Type PROCEDURE

Saline +50ml

If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No