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Completed

NCT Number: NCT03937037

Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline irrigation

Procedure

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

Primary outcomes

  1. Number of Participants with Recurrence of CBD Stones

    Time frame: 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 outcomes

  1. Number of Participants with Cholangitis

    Time frame: 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

  2. Number of Participants with Pancreatitis

    Time frame: 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

  3. Number of Participants with Bleeding

    Time frame: 1 month

    Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl

  4. Number of Participants with Perforation

    Time frame: 1 month

    Was defined as the presence of air or contrast in the retroperitoneal space

  5. Procedure time of each case

    Time frame: 7 days

    From the moment the endoscope entered, to the moment withdraw the scope

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 3, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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