Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After 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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2022-12-31

Brief Summary

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In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

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Detailed Description

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In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.

The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.

Conditions

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Stone - Biliary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Saline irrigation

CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.

Group Type EXPERIMENTAL

Saline irrigation

Intervention Type PROCEDURE

100ml saline irrigation after CBD stone removal with routine ERCP procedure

None saline irrigation

CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Saline irrigation

100ml saline irrigation after CBD stone removal with routine ERCP procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* With ERCP indications
* With mechanical lithotripsy during operation

Exclusion Criteria

* Unwillingness or inability to consent for the study
* Unstable vital signs
* Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No