Does Non-Steroidal Anti-Inflammatory Drugs (NSAID) protect from inflammation of the pancreas (pancreatitis) after Endoscopic Retrograde CholangioPancreatography (ERCP) of the bile ducts?

Phase 1

Conditions: Pancreatitis
MedDRA version: 20.0Level: PTClassification code 10033645Term: PancreatitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-004250-42-SE

Lead Sponsor: Västmanland County Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1000

Inclusion Criteria

•Age > = 18 years
•Patients (acute or elective) undergoing ERCP
•Signed Informed Consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

•Patients undergoing one step rendezvous ERCP in connection with cholecystectomy
•Patients hypersensitive against NSAID or having shown increased trouble with asthma, urticaria or acute rhinitis at intake of NSAID
• Established chronic heart failure (NYHA II-IV), ischemic cardiac disease, peripheral vascular disease and/or cerebrovascular disease
•Serious renal failure (GFR <30 ml/min)
• Serious coagulation disorder, alternatively earlier/ongoing ulcer bleeding
• Serious liver failure or hepatic porphyria
•Patients without anal channel after surgery making rectal administration of medication impossible
• Ongoing proctitis
•Patients not understanding Swedish
• Pregnant or nursing women
• Patients with regular/daily NSAID-medication

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if treatment with 100 mg Voltaren (Diclofenac) rectally administrated not more than 30 min before ERCP protects against post-ERCP (PEP).<br><br>;Secondary Objective: To assess if the treatment is safe (number of Adverse Events and mortality)<br>;Primary end point(s): Number of post-ERCP pancreatitis in the two groups (profylactic treatment/no treatment);Timepoint(s) of evaluation of this end point: From Baseline until follow-up of last patient, i.e. up to approximately two years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of Adverse Events<br>Number of deaths ;Timepoint(s) of evaluation of this end point: From Baseline until follow-up of last patient, i.e. up to approximately two years.