Clinical trial NCT06623513: Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis
Official title: A Single-Center, Prospective, Randomized, Controlled, Exploratory Trial Comparing the Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis: The PRECISE Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pancreatitis, Acute
Cholangiopancreatography, Endoscopic Retrograde
Keywords: Parecoxib
Indomethacin
Post-ERCP Pancreatitis
Efficacy
Safety
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years.
* Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum.

Exclusion Criteria:

* Previous papillectomy.
* Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention.
* Simple biliary stent removal or replacement without planned pancreatic duct intervention.
* Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis.
* Malignant tumor of the pancreatic head.
* Currently or recently (within 1 week) suffering from acute pancreatitis.
* Current or recent (within 1 week) use of NSAIDs.
* Recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers.
* History of significant adverse reactions to NSAIDs.
* Renal insufficiency (creatinine clearance \&lt; 30 mL/min).
* Moderate to severe hepatic impairment (Child-Pugh score ≥ 7).
* Severe cardiovascular or cerebrovascular disease.
* Patients with psychiatric disorders.
* Pregnant or breastfeeding patients.
* Patients without a rectum.
* Patients unwilling or unable to provide informed consent.

Primary outcomes:
measure: Incidence of Post-ERCP Pancreatitis (PEP)
timeFrame: 24 hours after ERCP procedure.
Secondary outcomes:
measure: Incidence of Moderate to Severe PEP
timeFrame: At discharge (up to 30 days)
measure: Incidence of Hyperamylasemia
timeFrame: 3 and 24 hours after ERCP procedure
measure: Post-Procedure Discomfort Symptoms
timeFrame: Baseline (pre-procedure), 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days)
measure: Bleeding, Perforation, Cholangitis, Cardiac Adverse Events, Renal Adverse Events
timeFrame: 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days)
Other outcomes:
Locations:
Study officials:
References: