Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT00419549 | Terminated Phase 2

• 1 other identifier: GE-ERCP-AP/2006
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

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.

Conditions

ERCP; Pancreatitis

Keywords

ERCP; Pancreatitis; Nitroglycerine; Valdecoxib

Outcome Measures

Primary Outcomes (1)

• Frequency of acute pancreatitis after ERCP

  48 hours

Secondary Outcomes (2)

• Frequency of pain

  24 hours

• Degree of hyper-amylasemia

  24 hours

Study Arms (3)

1

ACTIVE COMPARATOR

Valdecoxib

Drug: Valdecoxib

2

ACTIVE COMPARATOR

Drug: Glyceryl - trinitrate

3

NO INTERVENTION

Interventions

Glyceryl - trinitrate DRUG

Transdermal Patch once only

2

Valdecoxib DRUG

Single parenteral administration

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, India

Location

Related Publications (4)

• Kaffes AJ, Bourke MJ, Ding S, Alrubaie A, Kwan V, Williams SJ. A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis. Gastrointest Endosc. 2006 Sep;64(3):351-7. doi: 10.1016/j.gie.2005.11.060. Epub 2006 May 19.

  PMID: 16923481 BACKGROUND

• Moreto M, Zaballa M, Casado I, Merino O, Rueda M, Ramirez K, Urcelay R, Baranda A. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7. doi: 10.1067/mge.2003.29.

  PMID: 12518122 BACKGROUND

• Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Lazzell-Pannell L, Rashdan A, Temkit M, Lehman GA. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol. 2006 Jan;101(1):139-47. doi: 10.1111/j.1572-0241.2006.00380.x.

  PMID: 16405547 BACKGROUND

• Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

  PMID: 15173799 BACKGROUND

Related Links

• Patient information database with comprehensive details of ERCP and its complications, including pancreatitis

MeSH Terms

Conditions

Pancreatitis

Interventions

Nitroglycerin; valdecoxib

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Pramod K Garg, M.D., D.M.

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Vikram Bhatia, M.D., D.M.

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: October 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

IN (1)