Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Primary Purpose
Stone Clearance
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CBD stone removal via lithotripsy
Saline 50ml
Saline +50ml
Sponsored by
About this trial
This is an interventional treatment trial for Stone Clearance focused on measuring ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation
Eligibility Criteria
Inclusion Criteria:
- ERCP common bile duct stone patients were able to provide written informed consent;
- Size of stone large than 1.2 cm.
Exclusion Criteria:
- Unwillingness or inability to consent for the study;
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;
- Previous ERCP;
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, 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;
- Presence of intrahepatic duct stone;
- Malignancy.
Sites / Locations
- Hepatopancreatobiliary Surgery Institute of Gansu Province
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stone removal (Saline 50ml each time)
Arm Description
After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.
Outcomes
Primary Outcome Measures
Stone fragments clearance
Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
Secondary Outcome Measures
Post-ERCP cholangitis
Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections.
Bleeding
Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl.
Post-ERCP pancreatitis
Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure.
Perforation
Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
The procedure time
Was defined as the sum of times of all processes of endoscopic procedure.
Full Information
NCT ID
NCT03701009
First Posted
October 6, 2018
Last Updated
July 12, 2020
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
1. Study Identification
Unique Protocol Identification Number
NCT03701009
Brief Title
Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title
Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
Detailed Description
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone Clearance
Keywords
ERCP, Common bile duct stone, Cholangitis, Residual stone, Irrigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stone removal (Saline 50ml each time)
Arm Type
Other
Arm Description
After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.
Intervention Type
Procedure
Intervention Name(s)
CBD stone removal via lithotripsy
Intervention Description
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
Intervention Type
Procedure
Intervention Name(s)
Saline 50ml
Intervention Description
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
Intervention Type
Procedure
Intervention Name(s)
Saline +50ml
Intervention Description
If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.
Primary Outcome Measure Information:
Title
Stone fragments clearance
Description
Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Post-ERCP cholangitis
Description
Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections.
Time Frame
3 months
Title
Bleeding
Description
Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl.
Time Frame
3 months
Title
Post-ERCP pancreatitis
Description
Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure.
Time Frame
3 months
Title
Perforation
Description
Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
Time Frame
3 months
Title
The procedure time
Description
Was defined as the sum of times of all processes of endoscopic procedure.
Time Frame
3 months
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:
ERCP common bile duct stone patients were able to provide written informed consent;
Size of stone large than 1.2 cm.
Exclusion Criteria:
Unwillingness or inability to consent for the study;
Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;
Previous ERCP;
Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, 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;
Presence of intrahepatic duct stone;
Malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Li, MD,PhD
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Study Director
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
21737076
Citation
Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.
Results Reference
background
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Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
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