Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03708458

Enrollment

250

Registered

2018-10-17

Start date

2017-04-01

Completion date

2018-12-15

Last updated

2018-10-18

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

Conditions

Post-ERCP Pancreatitis

Keywords

endoscopic retrograde cholangiopancreatography (ERCP), post-ERCP pancreatitis (PEP), Nonsteroidal anti-inflammatory drugs (NSAID's), acetylcysteine (ACC)

Brief summary

The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.

Interventions

DRUGindomethacin suppository

the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

DRUGN-acetylcysteine (NAC)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age 18 years and older * diagnosis of choledocholithiasis * indication for ERCP procedures * willingness to participate in the study * the ability to sign the informed consent

Exclusion criteria

* presence of acute pancreatitis or other inflammatory diseases at admission * pregnancy * contraindication for NSAID administration * recent episode of upper digestive bleeding (less than one month) * hypersensibility to antioxidants hypersensibility to antioxidants * the necessity of a prophylactic pancreatic stent insertion * patients' disapproval to take part in the study

Design outcomes

Primary

Measure	Time frame	Description
Number of patients who develop post ERCP pancreatitis	24 hours post ERCP	Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis

Countries

Romania

Contacts

Primary ContactLAURA PAVEL, PhD Student

laura_pavel_88@yahoo.com+40751129600

Backup ContactGABRIELA STEFANESCU, PhD, Lecturer

gabriela.stefanescu@gmail.com+40744244266

Outcome results

None listed

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