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Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

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ClinicalTrials.gov Identifier: NCT03708458
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
PAVEL LAURA, Grigore T. Popa University of Medicine and Pharmacy

Brief Summary:
The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.

Condition or disease Intervention/treatment Phase
Post-ERCP Pancreatitis Drug: indomethacin suppository Drug: N-acetylcysteine (NAC) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: Control group
Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP
Drug: indomethacin suppository
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Active Comparator: Group A
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
Drug: indomethacin suppository
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Drug: N-acetylcysteine (NAC)
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Active Comparator: Group B
Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP
Drug: indomethacin suppository
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens




Primary Outcome Measures :
  1. Number of patients who develop post ERCP pancreatitis [ Time Frame: 24 hours post ERCP ]
    Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years and older
  • diagnosis of choledocholithiasis
  • indication for ERCP procedures
  • willingness to participate in the study
  • the ability to sign the informed consent

Exclusion Criteria:

  • presence of acute pancreatitis or other inflammatory diseases at admission
  • pregnancy
  • contraindication for NSAID administration
  • recent episode of upper digestive bleeding (less than one month)
  • hypersensibility to antioxidants hypersensibility to antioxidants
  • the necessity of a prophylactic pancreatic stent insertion
  • patients' disapproval to take part in the study

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): NCT03708458


Contacts
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Contact: LAURA PAVEL, PhD Student +40751129600 laura_pavel_88@yahoo.com
Contact: GABRIELA STEFANESCU, PhD, Lecturer +40744244266 gabriela.stefanescu@gmail.com

Locations
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Romania
Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași Recruiting
Iași, Romania, cod 700111
Contact: GHEORGHE BALAN, PROFESSOR    +40732402845    drbalanumfiasi@yahoo.com   
Sponsors and Collaborators
Grigore T. Popa University of Medicine and Pharmacy
Investigators
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Study Director: GHEORGHE BALAN, PhD, Professor "GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAŞI

Publications:

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Responsible Party: PAVEL LAURA, Principal Investigator, PhD Student, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03708458     History of Changes
Other Study ID Numbers: PEP_2017
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 PAVEL LAURA, Grigore T. Popa University of Medicine and Pharmacy:
endoscopic retrograde cholangiopancreatography (ERCP)
post-ERCP pancreatitis (PEP)
Nonsteroidal anti-inflammatory drugs (NSAID's)
acetylcysteine (ACC)
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Acetylcysteine
Indomethacin
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors