Trial record 49 of 78 for:    gastroenterology | Recruiting | Exclude Unknown | United States

A Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in High Risk Patients (INDIEH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Johns Hopkins University
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Asian Institute of Gastroenterology, India
Postgraduate Institute of Medical Education and Research
Apollo Gleneagles Hospitals, Kolkata
Information provided by (Responsible Party):
Vikesh Singh, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02116309
First received: April 14, 2014
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

Condition Intervention
Post-ERCP Acute Pancreatitis
Drug: Rectal Indomethacin
Drug: Epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Incidence of post-ERCP pancreatitis [ Time Frame: 24 hours after ERCP ] [ Designated as safety issue: No ]
    The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days.


Secondary Outcome Measures:
  • Severity of post-ERCP pancreatitis [ Time Frame: up to 30 days after ERCP ] [ Designated as safety issue: No ]
    Severity of post-ERCP pancreatitis (PEP) will be defined using the modified Atlanta criteria as mild PEP if there is no organ failure and no local / systemic complications; moderate PEP if there is organ failure that resolves within 48 hours (transient organ failure) and/ or local or systemic complications without persistent organ failure; severe PEP if there is persistent (>48 hours) single or multiple organ failure. Severity of PEP will also be defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for > 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention.


Estimated Enrollment: 948
Study Start Date: August 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rectal Indomethacin only
Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.
Drug: Rectal Indomethacin
Other Names:
  • Indocin
  • NSAIDs
Active Comparator: Rectal Indomethacin plus papillary spray of Epinephrine
Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.
Drug: Rectal Indomethacin
Other Names:
  • Indocin
  • NSAIDs
Drug: Epinephrine
Other Name: Adrenaline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major inclusion criteria (If patients meet at least 1 of the criteria):

    1. History of PEP
    2. Pancreatic sphincterotomy
    3. Pre-cut sphincterotomy
    4. Difficult cannulation (>5 attempts / 10 minutes to cannulate)
    5. Failed cannulation
    6. Pneumatic dilation of an intact sphincter
    7. Sphincter of Oddi dysfunction of Type I or Type II
  • Minor inclusion criteria (If patients meet at least 2 of the criteria):

    1. Age < 50 & Female gender
    2. History of acute pancreatitis (at least 2 episodes)
    3. >/= 3 pancreatic injections (with at least 1 injection in tail)
    4. Pancreatic acinarization
    5. Pancreatic Brush Cytology

Exclusion Criteria:

  1. Unwillingness or inability to consent for the study
  2. Age < 18 years
  3. Intrauterine pregnancy
  4. Breastfeeding mother
  5. Standard contraindications to ERCP
  6. Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine
  7. Chronic renal disease (Cr > 1.4)
  8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
  9. Acute pancreatitis (lipase peak) within 72 hours
  10. Known chronic calcific pancreatitis
  11. Pancreatic head mass
  12. Receiving pancreatic duct stent placement for any indication
  13. Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum
  14. ERCP for pancreatic/biliary stent removal or exchange without anticipated pancreatogram
  15. Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  16. Anticipated inability to follow protocol
  17. Sphincter of Oddi dysfunction of Type III
  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: NCT02116309

Contacts
Contact: Ayesha Kamal, M.B.B.S 4438050487 akamal3@jhmi.edu
Contact: Venkata S Akshintala, M.B.B.S 4106246955 vakshin1@jhu.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ayesha Kamal, M.B.B.S    443-805-0487    akamal3@jhmi.edu   
Principal Investigator: Vikesh k singh, M.D., M.Sc         
Sub-Investigator: Venkata S Akshintala, M.D.         
India
Asian Institute of gastroenterology Recruiting
Hyderabad, Andhra Pradesh, India, 500082
Contact: Nageshwar Reddy Duvvuru         
Contact: Rupjyoti Talukdar         
Principal Investigator: Nageshwar R Duvvuru, M.D., D.M         
Principal Investigator: Rupjyoti Talukdar, M.D., D.N.B         
Apollo Gleneagles Hospitals Recruiting
Kolkata, West Bengal, India, 700054
Contact: Mahesh K Goenka, M.D., D.M.         
Principal Investigator: Mahesh K Goenka, M.D., D.M.         
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Rakesh Kochhar, M.D., D.M.         
Principal Investigator: Rakesh Kochhar, M.D., D.M.         
Sponsors and Collaborators
Johns Hopkins University
American Society for Gastrointestinal Endoscopy
Asian Institute of Gastroenterology, India
Postgraduate Institute of Medical Education and Research
Apollo Gleneagles Hospitals, Kolkata
Investigators
Principal Investigator: Vikesh K Singh, M.D., M.Sc. Johns Hopkins University
  More Information

Publications:
Responsible Party: Vikesh Singh, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02116309     History of Changes
Other Study ID Numbers: IRB00034715  IRB00034715 
Study First Received: April 14, 2014
Last Updated: February 1, 2016
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Indomethacin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents

ClinicalTrials.gov processed this record on August 23, 2016