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Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in 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. Identifier: NCT01946984
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):
Yasser Abu-Safieh, Specialized Arab Hospital

Brief Summary:
  1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
  2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
  3. The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
  4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis. Procedure: ERCP Drug: Diclofenac hydroxyethylpyrrolidine Drug: Normal Saline Phase 1

Detailed Description:
  • All patients signed informed consents for the procedure, and the participation in the study.
  • Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
  • Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
  • A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
  • Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:

    1. the total time of the procedure,
    2. the number of attempts at cannulation,
    3. the number of pancreatic duct cannulation,
    4. the final diagnosis by ERCP,
    5. whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.
  • Serum amylase was determined 12 hours after ERCP.

    • If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
    • Acute pancreatitis was defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
  • Statistical analysis:

    1. Randomization was done by the GI nurse, concealed envelop
    2. Data were summarized by descriptive statistics.
    3. The Chi square was used to compare categorical patient data.
    4. The Student's t test was used to compare continuous variables.
    5. Two-tailed P < 0.05 was considered to indicate significance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Intramuscular Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, In Post ERCP Pancreatitis.
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: Diclofenac,75 mg, 3 ml,
patients were given Diclofenac IM before ERCP.
Procedure: ERCP
endoscopy, retrograde cholangio-pancreaticography.

Drug: Diclofenac hydroxyethylpyrrolidine
Placebo Comparator: Normal Saline, 3ml, IM
patients were given normal saline 3 ml before ERCP
Procedure: ERCP
endoscopy, retrograde cholangio-pancreaticography.

Drug: Normal Saline

Primary Outcome Measures :
  1. prevention of pancreatitis, [ Time Frame: within a week after procedure ]
    1. Patients with epigastric pain, back pain, and epigastric tenderness,
    2. And all had serum amylase measured after the procedure, if elevated more than 3 folds of normal, the patient was diagnosed to have post ERCP pancreatitis,

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • any patient above the age of 16, referred for ERCP

Exclusion Criteria:

  • 1.could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula 2. ERCP done recently 3. Stent replacement 4. Congestive Heart Failure(CHF) 5. Asthma

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 identifier (NCT number): NCT01946984

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Palestinian Territories, Occupied
SAH hospital
Nablus, West Bank, Palestinian Territories, Occupied, 970
Sponsors and Collaborators
Specialized Arab Hospital
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Principal Investigator: Yasser Abu-Safieh, MD, AGAF Specialized Arab Hospital

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Responsible Party: Yasser Abu-Safieh, Associate Prof, MD, AGAF, Specialized Arab Hospital Identifier: NCT01946984     History of Changes
Other Study ID Numbers: Specialized Arab Hospital
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013
Keywords provided by Yasser Abu-Safieh, Specialized Arab Hospital:
diclofenac, ERCP and pancreatitis
Additional relevant MeSH terms:
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Diclofenac hydroxyethylpyrrolidine
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action