Post ERCP Pancreatitis Prevention in Average Risk Patients

NCT01784445 | Completed Phase 4

• 1 other identifier: PEP 2013
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatitis

Keywords

Endoscopic Retrograde Cholangiopancreatography,

Outcome Measures

Primary Outcomes (1)

• Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium

  One year

Other Outcomes (1)

• Time to discharge from hospital

  One year

Study Arms (2)

Ceftazidime plus placebo

EXPERIMENTAL

Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo

Drug: Ceftazidime

Diclophenac sodium plus placebo

ACTIVE COMPARATOR

Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo

Drug: Ceftazidime

Interventions

Ceftazidime DRUG

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

Also known as: Fortaz

Ceftazidime plus placebo; Diclophenac sodium plus placebo

Eligibility Criteria

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

You may qualify if:

• o All patients undergone to ERCP irrespectively about the diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Rijeka: lead

Study Sites (1)

Clinical Hospital Centre

Rijeka, Kresimirova 42, 51000, Croatia

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Ceftazidime

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Goran Hauser, MD, PhD

  University Hospital Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Goran Hauser, MD, PhD

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 5, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CR (1)