Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Primary Purpose
Stone - Biliary
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Saline irrigation
Sponsored by
About this trial
This is an interventional prevention trial for Stone - Biliary focused on measuring ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation, Recurrence
Eligibility 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
Sites / Locations
- Hepatopancreatobiliary Surgery Institute of Gansu Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Saline irrigation
None saline irrigation
Arm Description
CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.
CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.
Outcomes
Primary Outcome Measures
Number of Participants with Recurrence of CBD Stones
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
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
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
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
Was defined as the presence of air or contrast in the retroperitoneal space
Procedure time of each case
From the moment the endoscope entered, to the moment withdraw the scope
Full Information
NCT ID
NCT03937037
First Posted
May 1, 2019
Last Updated
January 20, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
1. Study Identification
Unique Protocol Identification Number
NCT03937037
Brief Title
Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Official Title
Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone - Biliary
Keywords
ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation, Recurrence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline irrigation
Arm Type
Experimental
Arm Description
CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.
Arm Title
None saline irrigation
Arm Type
No Intervention
Arm Description
CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.
Intervention Type
Procedure
Intervention Name(s)
Saline irrigation
Intervention Description
100ml saline irrigation after CBD stone removal with routine ERCP procedure
Primary Outcome Measure Information:
Title
Number of Participants with Recurrence of CBD Stones
Description
Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of Participants with Cholangitis
Description
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
Time Frame
3 years
Title
Number of Participants with Pancreatitis
Description
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
Time Frame
3 years
Title
Number of Participants with Bleeding
Description
Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl
Time Frame
1 month
Title
Number of Participants with Perforation
Description
Was defined as the presence of air or contrast in the retroperitoneal space
Time Frame
1 month
Title
Procedure time of each case
Description
From the moment the endoscope entered, to the moment withdraw the scope
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, MD,PhD
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatopancreatobiliary Surgery Institute of Gansu Province
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29610513
Citation
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.
Results Reference
background
PubMed Identifier
19249039
Citation
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.
Results Reference
background
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Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
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