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The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis (ERCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754491
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.

Condition or disease Intervention/treatment Phase
Cholangitis; Choledocholithiasis Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis Not Applicable

Detailed Description:
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: One stage stone removal in mild cholangitis
one-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history
Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis
one stage of stone removal in mild or moderate cholangitis.

Experimental: One stage stone removal in moderate cholangitis
one-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history
Behavioral: One stage treatment for mild and moderate cholangitis with choledocholithiasis
one stage of stone removal in mild or moderate cholangitis.




Primary Outcome Measures :
  1. Post ERCP pancreatitis [ Time Frame: After ERCP, an average of 7 days ]
    Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain

  2. Bowel perforation [ Time Frame: After ERCP, an average of 7 days ]
    Participants with sign of bowel perforation after ERCP

  3. Papillary bleeding [ Time Frame: After ERCP, an average of 7 days ]
    Participants with papillary bleeding after ERCP

  4. Success rate of stone removal [ Time Frame: an average of 14 days. ]
    Complete bile duct stone clearance

  5. Cost of hospitalization [ Time Frame: From emergent department to the timing of being discharged, and an average of 30 days ]
    Total cost in two individual groups in hospitalization.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: an average of 30 days ]
    Mortality during and after discharged



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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:

  • naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.

Exclusion Criteria:

  • procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
  • stenosis of the pyloric ring ;
  • tumor-related obstruction;
  • failure to locate the papilla ;
  • active peptic ulcer bleeding ;
  • intolerance due to inadequate sedation
  • CBD sludge;
  • non-naïve papilla in ERCP

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): NCT03754491


Contacts
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Contact: CHIH-MING LIANG, MD +886975056294 gimy54861439@gmail.com

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Chih-Ming Liang, MD    +886-975056294    gimy54861439@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: CHIH-MING LIANG, MD Chang Gung Memorial Hospital
Publications of Results:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03754491    
Other Study ID Numbers: gimy54861439
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: January 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 Chang Gung Memorial Hospital:
Acute cholangitis
choledocholithiasis
ERCP
One-stage treatment
Additional relevant MeSH terms:
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Cholangitis
Choledocholithiasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Common Bile Duct Diseases
Cholelithiasis