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Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)

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ClinicalTrials.gov Identifier: NCT03701009
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary:
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

Condition or disease Intervention/treatment Phase
Stone Clearance Procedure: CBD stone removal via lithotripsy Procedure: Saline 50ml Procedure: Saline +50ml Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Stone removal (Saline 50ml each time)
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.
Procedure: CBD stone removal via lithotripsy
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.

Procedure: Saline 50ml
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.

Procedure: Saline +50ml
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 Measures :
  1. Stone fragments clearance [ Time Frame: 3 months ]
    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 :
  1. Post-ERCP cholangitis [ Time Frame: 3 months ]
    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.

  2. Bleeding [ Time Frame: 3 months ]
    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.

  3. Post-ERCP pancreatitis [ Time Frame: 3 months ]
    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.

  4. Perforation [ Time Frame: 3 months ]
    Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.

  5. The procedure time [ Time Frame: 3 months ]
    Was defined as the sum of times of all processes of endoscopic procedure.



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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:

  • 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.

Information from the National Library of Medicine

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): NCT03701009


Locations
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China, Gansu
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, China, 730000
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
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Study Director: Xun Li, MD,PhD Hepatopancreatobiliary Surgery Institute of Gansu Province
Publications:
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Responsible Party: Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT03701009    
Other Study ID Numbers: Saline irrigation in ERCP
First Posted: October 9, 2018    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 Hepatopancreatobiliary Surgery Institute of Gansu Province:
ERCP
Common bile duct stone
Cholangitis
Residual stone
Irrigation
Additional relevant MeSH terms:
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Calculi
Pathological Conditions, Anatomical