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Indomethacin Decreases Post-ERCP Pancreatitis (Indomethacin)

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ClinicalTrials.gov Identifier: NCT02110810
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

Brief Summary:
Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.

Condition or disease Intervention/treatment Phase
Post ERCP Acute Pancreatitis Drug: Indomethacin Drug: 2.6-g suppository of glycerin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rectal Indomethacin Decreases the Incidence of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography in High-risk Patients
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Indomethacin
100 mg of Indomethacin suppository immediately afterwards while still under sedation
Drug: Indomethacin
Indomethacin suppository of 100 mg immediately afterwards while still under sedation

Placebo Comparator: 2.6-g suppository of glycerin
suppository of 2.4 g of glycerin immediately afterwards while still under sedation
Drug: 2.6-g suppository of glycerin
to receive a 2.4 g of glycerin suppository immediately afterwards while still under sedation
Other Name: glycerin suppository




Primary Outcome Measures :
  1. Post ERCP Acute Pancreatitis [ Time Frame: 48 hours after the procedure. ]
    Defined as the development of new or increased abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal until 24 h after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights.


Secondary Outcome Measures :
  1. Severity of post-ERCP pancreatitis [ Time Frame: 48 hours after procedure. ]
    was determined according to consensus guidelines, with mild post-ERCP pancreatitis resulting in hospitalization of < 3 days, and moderate post-ERCP pancreatitis resulting in hospitalization of 4-10 days

  2. Acute Pancreatitis [ Time Frame: During 30 days after hospital discharge. ]
    Patients who developed Acute Pancreatitis after hospital discharge with presence of abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase >3 times the upper limit of normal.

  3. Asymptomatic hyperamylasemia [ Time Frame: 48 hours after procedue. ]
    any amylase level at least three times above the normal serum level in the absence of abdominal pain.

  4. Measurement of serum amylase [ Time Frame: 2 hours post-ERCP ]
    measured in all patients right after procedure and during surveillance (3 hours).

  5. Routine laboratory examinations [ Time Frame: 2 hours after procedure and daily until hospital discharge, an expected average of 10 days. ]
    All laboratory exams were performed when acute pancreatitis of any etiology was established



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • If they met one or more of the following criteria:

    • a clinical suspicion of SOD dysfunction;
    • or a history of post-ERCP pancreatitis, pancreatic
    • or precut sphincterotomy,
    • more than eight cannulation attempts,
    • pneumatic dilatation of an intact biliary sphincter,
    • or ampullectomy
  • Patients were also eligible for inclusion if they met two of the following criteria:

    • aged 50 years or younger and female gender
    • or a history of recurrent pancreatitis (>2 episodes),
    • three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas,
    • excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,
    • or the need for acquisition of a cytology specimen from the pancreatic duct with the use of a tissue-sampling brush.

Exclusion Criteria:

  • unwillingness or inability to consent for the study
  • pregnancy
  • breast feeding
  • standard contraindications for ERCP
  • hypersensitivity to aspirin or NSAIDs
  • previous use of NSAIDs within 1 week
  • renal failure (creatinine clearance rate >1.4 mg/dL)
  • active or recent (< 4 weeks) gastrointestinal hemorrhage
  • chronic calcified pancreatitis
  • pancreatic head malignancy
  • any procedure performed on the major papilla/ventral pancreatic duct in patients with a pancreatic divisum
  • previous ERCP for biliary stent removal or exchange without an anticipated pancreatogram
  • subjects with prior biliary sphincterotomy and scheduled for repeat biliary therapy without an anticipated pancreatogram
  • or anticipated inability to follow our protocol

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): NCT02110810


Locations
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Mexico
Department of Gastrointestinal Endoscopy and Department of Gastroenterology of the Specialties Hospital of the Western Medical Center of the Mexican Institute of Social Security.
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: González-Ojeda Alejandro, Ph.D., M.D. Instituto Mexicano del Seguro Social

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandro Gonzalez-Ojeda, PhD. MD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02110810     History of Changes
Other Study ID Numbers: Indomethacin-2014-02
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social:
post-ERCP Acute Pancreatitis
Indomethacin
NSAIDs
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Glycerol
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
Cryoprotective Agents
Protective Agents