Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Completed

Conditions

Stone - Biliary

Treatments

Procedure: Saline irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT03937037

Saline irrigation follow-up

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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 / 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