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Intravenous Parecoxib for prevention of Post-ERCP Pancreatitis (PEP) prospective, single center, randomized controlled trial.

Intravenous Parecoxib for prevention of Post-ERCP Pancreatitis (PEP) prospective, single center, randomized controlled trial.

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221020002
Enrollment
428
Registered
2022-10-20
Start date
2022-10-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Post ERCP Pancreatitis Post ERCP Abdominal pain score Risk factor for Post ERCP Pancreatitis ERCP Pancreatitis Dynastat Parecoxib sodium

Interventions

COX-2 inhibitor administered parenterally. It is a prodrug that is rapidly hydrolysed in vivo to its active form, valdecoxib. Its metabolite in liver and excrete mainly in urine. It has been approved
Experimental Drug,Placebo Comparator No treatment
Parecoxib sodium,Normal saline

Sponsors

MNRH Institution Review board
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing ERCP at Maharat Nakhon Ratchasima Hospital Age more than 20 years

Exclusion criteria

Exclusion criteria: Hypersensitivity/Contraindication to parecoxib, NSAIDs, or sulfonamide Active/Recent Gastrointestinal bleeding or Recent Peptic ulcer disease within 4 weeks Renal dysfunction (Cr > 1.5 mg/dL) History of Myocardial infarction ECOG 4 NSAIDs use during preceding week (ASA 325 mg daily or less) Acute pancreatitis less than 2 weeks before ERCP History of Bilioenteric bypass History of chronic pancreatitis Pregnancy or Breast feeding Patient with HIV infection Refused to participate

Design outcomes

Primary

MeasureTime frame
Post ERCP Pancreatitis before patient discharge from admission Criteria for diagnosis Pancreatitis as consensus criteria

Secondary

MeasureTime frame
Post operative pain score when patient arrived at inpatient department after ERCP Abdominal pain score ,Risk factor for Post ERCP Pancreatitis within 3 months after end of study Compare incidence of Post ERCP Pancreatitis between Parecoxib and placebo

Countries

Thailand

Contacts

Public ContactAekaritch Nattigon

Maharat Nakorn Ratchasima Hospita

aekarit123@hotmail.com0968871516

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026