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COX-2 Inhibitor to Prevent Post-ERCP Pancreatitis

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: NCT02964403
Recruitment Status : Unknown
Verified November 2016 by Wang zheng, First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Wang zheng, First Affiliated Hospital Xi'an Jiaotong 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. The mechanism of indomethacin is dependent on COX-2 inhibitor.

According to data, we design the project. The purpose of this study is to determine whether COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.


Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Drug: Cox-2 Drug: Indomethacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect Observation Study of COX-2 Inhibitor to Prevent Post-ERCP Pancreatitis
Study Start Date : December 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Cox-2
Cox-2 inhibitor ParecoxibNa 40mg pre-ERCP injection
Drug: Cox-2
Other Name: ParecoxibNa

Active Comparator: Indomethacin
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Drug: Indomethacin
Other Name: NSAID




Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Moderate-to-severe Pancreatitis [ Time Frame: 30 days ]


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.


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Ages Eligible for Study:   18 Years to 80 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
  • Renal failure (Cr >1.4mg/dl=120umol/l)
  • 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): NCT02964403


Contacts
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Contact: Zheng Wang, MD 0086-15902993665 wangzheng0923@126.com
Contact: Jun Lv xjyfyllh@163.com xjyfyllh@163.com

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
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Responsible Party: Wang zheng, Vice chief of department of HPB Surgery, First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02964403    
Other Study ID Numbers: XJTU1AFCT-2016-008
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Wang zheng, First Affiliated Hospital Xi'an Jiaotong University:
COX-2
ERCP
Pancreatitis
Additional relevant MeSH terms:
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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