Trial record 21 of 352 for:    pancreatitis

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT02002650
First received: December 1, 2013
Last updated: June 5, 2015
Last verified: June 2015
  Purpose

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. A number of trials have evaluated that rectal NSAIDs (non-steroidal anti-inflammatory drug) can prevent post-ERCP pancreatitis (PEP) in high risk patients. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk factor patients, may preventing the PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional regimen.


Condition Intervention
Post-ERCP Acute Pancreatitis
Drug: Pre-operational rectal Indomethacin
Drug: Post-operational Rectal Indomethacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Controlled Trial of Pre-operational Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in Average-risk Patients.

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Post-ERCP Pancreatitis [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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:
  • Severity of pancreatitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-operational group
Pre-operational rectal Indomethacin for all patients.
Drug: Pre-operational rectal Indomethacin
Rectal Indomethacin was administrated 30min to 60min before ERCP for all patients.
Active Comparator: Post-operational group
Post-operational rectal Indomethacin for high-risk patients.
Drug: Post-operational Rectal Indomethacin
Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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 chronic calcific pancreatitis, pancreatic divisum or 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002650

Contacts
Contact: Yanglin Pan, M.D. 86-29-84771536 panyl@fmmu.edu.cn
Contact: Hui Luo, M.D. 86-29-84771536 fmmulh@163.com

Locations
China, Gansu
The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wence Zhou, M.D.       zhouwc129@163.com   
Principal Investigator: Wence Zhou, M.D.         
China, Ningxia
General Hospital of NingXia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Qi Wang, M.D.    8613895098592    wq-6562@163.com   
Contact: Ming Li, M.D.    8613519216501    nyfygdwk@163.com   
Principal Investigator: Ming Li, M.D         
China, Shaanxi
No. 451 Hospital Recruiting
Xi'an, Shaanxi, China, 710054
Contact: Yi Zhou, M.D.    8613399289251    Zhouyi02192005@aliyun.com   
Principal Investigator: Yi Zhou, M.D.         
The First Affiliated Hospital Of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Hao Sun, M.D.    862985323905    Sunhaoxjyf@126.com   
Principal Investigator: Hao Sun, M.D.         
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yanglin Pan, M.D.    86-29-84771536    panyl@fmmu.edu.cn   
Contact: Hui Luo, M.D.    86-29-84771536    fmmulh@163.com   
Principal Investigator: Hui Luo, M.D.         
China, Xinjiang
Urumqi General Hospital of Lanzhou Military Region Recruiting
Urumqi, Xinjiang, China, 830002
Contact: Zhan Guo, M.D.    8613999116558    niezg@vip.sina.com   
Contact: Ting Lei, M.D.    8618999838871    lting.xj@163.com   
Principal Investigator: Ting Lei, M.D.         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Study Director: Yanglin Pan, M.D. Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
  More Information

Publications:
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02002650     History of Changes
Other Study ID Numbers: 20131106-7, 20131106-7
Study First Received: December 1, 2013
Last Updated: June 5, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
Indomethacin, pancreatitis, ERCP

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on August 02, 2015