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Trial record 1 of 1 for:    "NCT00419549"
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Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)

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: NCT00419549
Recruitment Status : Terminated (Because one of the drugs Valdecoxib was withdrawn due to safety concerns.)
First Posted : January 8, 2007
Last Update Posted : January 29, 2009
Information provided by:
All India Institute of Medical Sciences, New Delhi

Brief Summary:

ERCP is a diagnostic and therapeutic procedure that is required in patients with suspected common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may occur as a complication of this procedure after about 5-10% of the ERCP procedures. This complication manifests as persisting pain 24 hours or more after ERCP, along with raised levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence of this complication is unpredictable. There have been a number of attempts to prevent this complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin, steroids, etc. However, these have not been successful. Recently, a study showed that application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors may also be effective.

The investigators want to study whether transdermal patch of glyceryl trinitrate or administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent post-ERCP pancreatitis in our patients who undergo an ERCP.

Condition or disease Intervention/treatment Phase
ERCP Pancreatitis Drug: Glyceryl - trinitrate Drug: Valdecoxib Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Transdermal Glyceryl-Trinitrate and Parecoxib (Valdecoxib) for the Prevention of Post -ERCP Pancreatitis
Study Start Date : October 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: 1
Drug: Valdecoxib
Single parenteral administration

Active Comparator: 2 Drug: Glyceryl - trinitrate
Transdermal Patch once only

No Intervention: 3

Primary Outcome Measures :
  1. Frequency of acute pancreatitis after ERCP [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Frequency of pain [ Time Frame: 24 hours ]
  2. Degree of hyper-amylasemia [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • All patients aged 18 years and above undergoing first ERCP procedure

Exclusion Criteria:

  • Active acute pancreatitis,
  • Lower end malignant bile duct block,
  • Patients undergoing repeat procedures,including those with previous sphincterotomy
  • Ongoing therapy with nitrates, calcium channel blockers, somatostatin or octreotide
  • Patients with bleeding diathesis.
  • Patients with chronic pancreatitis
  • Patients with cardiac comorbidity

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): NCT00419549

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All India Institute of Medical Sciences
New Delhi, India
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
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Study Director: Pramod K Garg, M.D., D.M. All India Institute of Medical Sciences, New Delhi
Principal Investigator: Vikram Bhatia, M.D., D.M. All India Institute of Medical Sciences, New Delhi

Additional Information:
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Responsible Party: Pramod Kumar Garg, All India Institute of Medical Sciences Identifier: NCT00419549     History of Changes
Other Study ID Numbers: GE-ERCP-AP/2006
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Vasodilator Agents