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出境医 / 临床实验 / Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

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 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
Layout table for study information
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
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.
Outcome Measures
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

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Wenbo Meng, MD,PhD Hepatopancreatobiliary Surgery Institute of Gansu Province
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		Recurrence of CBD Stones [ Time Frame: 3 years ]
Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • 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
  • 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
  • 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
  • Number of Participants with Perforation [ Time Frame: 1 month ]
    Was defined as the presence of air or contrast in the retroperitoneal space
  • Procedure time of each case [ Time Frame: 7 days ]
    From the moment the endoscope entered, to the moment withdraw the scope
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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
  • 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
  • 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
  • Perforation [ Time Frame: 1 month ]
    Was defined as the presence of air or contrast in the retroperitoneal space
  • Procedure time [ Time Frame: 7 days ]
    From the moment the endoscope entered, to the moment withdraw the scope
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Official Title  ICMJE Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Stone - Biliary
Intervention  ICMJE Procedure: Saline irrigation
100ml saline irrigation after CBD stone removal with routine ERCP procedure
Study Arms  ICMJE
  • Experimental: Saline irrigation
    CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.
    Intervention: Procedure: Saline irrigation
  • No Intervention: None saline irrigation
    CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.
Publications *
  • Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.
  • Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2020) 		180
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		162
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenbo Meng, MD,PhD +8613919177177 mengwb@lzu.edu.cn
Contact: Yudong Wang, MD +8613669335218 wangyd17@lzu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937037
Other Study ID Numbers  ICMJE Saline irrigation follow-up
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
Study Sponsor  ICMJE Hepatopancreatobiliary Surgery Institute of Gansu Province
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wenbo Meng, MD,PhD Hepatopancreatobiliary Surgery Institute of Gansu Province
PRS Account Hepatopancreatobiliary Surgery Institute of Gansu Province
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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