Post ERCP Pancreatitis Prevention in Average Risk Patients

Pancreatitis Clinical Trial

Official title:

Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784445
• Other study ID #: PEP 2013
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2013
• Last updated: April 6, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: HALMED (Croatian Agency for Drugs and Medicinal Products)
• Study type: Interventional

Clinical Trial Summary

Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.

Description:

Study type:

Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4

Conditions or Focus of the study: Post ERCP pancreatitis

Intervention information

• Intervention Names ERCP

• Arm Information

• Arm 1:Ceftazidime

• Arm 2 (active comparator): Diclophenac potassium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• o All patients undergone to ERCP irrespectively about the diagnosis

Exclusion Criteria:

• o Unwillingness or inability to consent for the study

• Age < 18 years

• Previous ERCP (papillotomy)

• Intrauterine pregnancy

• Breast feeding mother

• Allergy to Aspirin or NSAIDs and Ceftazidime

• NSAID or antibiotic use within 1 week (ASA 325 mg daily or less acceptable)

• Renal failure (Cr > 1.4)

• Active or recent (within 4 weeks) gastrointestinal hemorrhage

• Existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP

• Anticipated inability to follow protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• Ceftazidime
Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre	Rijeka	Kresimirova 42

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to discharge from hospital	Influence of PEP severity on time to discharge from hospital	One year	No
Primary	Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium		One year	No