Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
ERCP Pancreatitis |
Drug: Glyceryl - trinitrate Drug: Valdecoxib |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of Transdermal Glyceryl-Trinitrate and Parecoxib (Valdecoxib) for the Prevention of Post -ERCP Pancreatitis |
- Frequency of acute pancreatitis after ERCP [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Frequency of pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Degree of hyper-amylasemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 371 |
| Study Start Date: | October 2003 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Valdecoxib
|
Drug: Valdecoxib
Single parenteral administration
|
| Active Comparator: 2 |
Drug: Glyceryl - trinitrate
Transdermal Patch once only
|
| No Intervention: 3 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| India | |
| All India Institute of Medical Sciences | |
| New Delhi, India | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Pramod Kumar Garg, All India Institute of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00419549 History of Changes |
| Other Study ID Numbers: | GE-ERCP-AP/2006 |
| Study First Received: | January 5, 2007 |
| Last Updated: | January 28, 2009 |
| Health Authority: | India: Ministry of Health |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
ERCP Pancreatitis Nitroglycerine Valdecoxib |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases Nitroglycerin Valdecoxib Parecoxib Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013