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Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

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ClinicalTrials.gov Identifier: NCT03937037
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937037


Contacts
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Contact: Wenbo Meng, MD,PhD +8613919177177 mengwb@lzu.edu.cn
Contact: Yudong Wang, MD +8613669335218 wangyd17@lzu.edu.cn

Locations
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China, Gansu
Hepatopancreatobiliary Surgery Institute of Gansu Province Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wenbo Meng, MD,PhD    +8613919177177    mengwb@lzu.edu.cn   
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
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Principal Investigator: Wenbo Meng, MD,PhD Hepatopancreatobiliary Surgery Institute of Gansu Province
More Information
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Publications:

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Responsible Party: Wenbo Meng, M.D., Ph. D, Direct of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT03937037    
Other Study ID Numbers: Saline irrigation follow-up
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province:
ERCP
Common bile duct stone
Cholangitis
 Residual stone
Irrigation
Recurrence
Additional relevant MeSH terms:
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Choledocholithiasis
Recurrence
Disease Attributes
Pathologic Processes
Common Bile Duct Diseases
 Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis