Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (Indomethacin)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002650
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : May 27, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Brief Summary:
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Drug: Pre-ERCP rectal Indomethacin Drug: Post-operational Rectal Indomethacin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Pre-ERCP group
Pre-ERCP rectal Indomethacin in all patients.
Drug: Pre-ERCP rectal Indomethacin
Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Active Comparator: Post-ERCP group
Post-ERCP rectal Indomethacin in high-risk patients.
Drug: Post-operational Rectal Indomethacin
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.




Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 30 days ]
    Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.


Secondary Outcome Measures :
  1. Moderate-to-severe Pancreatitis [ Time Frame: 30 days ]
    Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing diagnostic or therapeutic ERCP.

Exclusion Criteria:

  • Unwillingness or inability to consent for the study;
  • Age < 18 years old;
  • Intrauterine pregnancy;
  • Breastfeeding mother;
  • Standard contraindications to ERCP;
  • Allergy to NSAIDs;
  • Received NSAIDs in prior 7 days;
  • Renal failure (Cr >1.4mg/dl=120umol/l);
  • Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
  • Acute pancreatitis within 72 hours;
  • Known pancreatic head mass;
  • Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
  • ERCP for biliary stent removal or exchange without anticipated pancreatogram;
  • Known active cardiovascular or cerebrovascular disease.
  • Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

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): NCT02002650


Locations
Layout table for location information
China, Gansu
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
China, Ningxia
General Hospital of NingXia Medical University
Yinchuan, Ningxia, China, 750004
China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
No. 451 Hospital
Xi'an, Shaanxi, China, 710054
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
China, Xinjiang
Urumqi General Hospital of Lanzhou Military Region
Urumqi, Xinjiang, China, 830002
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Layout table for investigator information
Study Director: Yanglin Pan, M.D. Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02002650    
Other Study ID Numbers: 20131106-7
20131106-7 ( Other Identifier: Ethics committee of Xijing Hospital )
First Posted: December 6, 2013    Key Record Dates
Results First Posted: May 27, 2016
Last Update Posted: June 29, 2016
Last Verified: May 2016
Keywords provided by Yanglin Pan, Fourth Military Medical University:
Indomethacin, pancreatitis, ERCP
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action