Post ERCP Pancreatitis Prevention in Average Risk Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01784445

Enrollment

124

Registered

2013-02-05

Start date

2013-06-30

Completion date

2015-02-28

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis

Keywords

Endoscopic Retrograde Cholangiopancreatography,

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.

Detailed 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

Interventions

DRUGCeftazidime

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
Time to discharge from hospital	One year	Influence of PEP severity on time to discharge from hospital

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026