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

Does NSAID protect against Post-ERCP Pancreatitis? A parallel-group, open, randomised, multicentre study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004250-42-SE

Enrollment

1000

Registered

2018-07-19

Start date

2018-08-20

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Pancreatitis MedDRA version: 20.0 Level: PT Classification code 10033645 Term: Pancreatitis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Diclofenac Product Name: Diclofenac Pharmaceutical Form: Suppository INN or Proposed INN: DICLOFENAC SODIUM CAS Number: 15307-81-0 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). ;Secondary Objective: To assess if the treatment is safe (number of Adverse Events and mortality) ;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.	—

Measure

Time frame

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). ;Secondary Objective: To assess if the treatment is safe (number of Adverse Events and mortality) ;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.

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Secondary

Measure	Time frame
Secondary end point(s): Number of Adverse Events 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.	—

Countries

Sweden

Contacts

Public ContactCoordinating Co-Investigator

Västerås Hospital

eva.lena.syren@regionvastmanland.se+46(0)2117 30 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026