Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)

Overall Status

Recruiting

CT.gov ID

NCT03937037

Collaborator

(none)

180

Enrollment

Location

Arms

43.7

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stone - Biliary	Procedure: Saline irrigation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Actual Study Start Date :

May 10, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Saline irrigation CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.	Procedure: Saline irrigation 100ml saline irrigation after CBD stone removal with routine ERCP procedure
No Intervention: None saline irrigation CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.

Arm

Intervention/Treatment

Experimental: Saline irrigation

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

Procedure: Saline irrigation

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

No Intervention: None saline irrigation

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

Outcome Measures

Primary Outcome Measures

Number of Participants with Recurrence of CBD Stones [3 years]
Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not

Secondary Outcome Measures

Number of Participants with Cholangitis [3 years]
Temperature should be more than 38 ℃, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal
Number of Participants with Pancreatitis [3 years]
Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after surgery, and there are also radiographic evidence suggesting the shape of pancreas has changed
Number of Participants with Bleeding [1 month]
Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl
Number of Participants with Perforation [1 month]
Was defined as the presence of air or contrast in the retroperitoneal space
Procedure time of each case [7 days]
From the moment the endoscope entered, to the moment withdraw the scope

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 /

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