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Efficacy of paraxib in the prevention and treatment of severe hypertriglyceridemia-associated pancreatitis

Efficacy of paraxib in the prevention and treatment of severe hypertriglyceridemia-associated pancreatitis: a multicenter, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118852
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Acute pancreatitis

Interventions

control group:placebo control group
experimental group:Parecoxib group

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-75, gender not limited; 2.The diagnostic criteria for acute pancreatitis are met when two of the following three criteria are present: (1) characteristic symptoms of acute pancreatitis, including persistent epigastric pain; (2) serum amylase and/or lipase levels >= 3 times the upper limit of normal; and (3) characteristic imaging findings of acute pancreatitis, such as CT, ultrasound, or MRI. 3.Blood triglyceride >= 11.30mmol/L; 4.= 2 as the predictive criterion); 6.Voluntary participation in the study and signing of the informed consent form;

Exclusion criteria

Exclusion criteria: 1.The biliary cause should meet one of the following three points: (1) common bile duct stones or common bile duct dilation (>8mm,>1.2mm in cholecystectomy); (2) serum bilirubin>40umol/L; (3) gallstones accompanied by AKP or ALT higher than 3 times the upper limit of normal. 2.Concomitant alcohol-related etiology: alcohol consumption >= 50g/day for>5 years; 3.Pregnant and breastfeeding women; 4.Individuals with a history of hypersensitivity to parecoxib or other active pharmaceutical ingredients used in the study; 5.NSAIDs are contraindicated in patients with active gastrointestinal bleeding, peptic ulcers, or other severe digestive system disorders such as cirrhosis with esophageal varices, ulcerative colitis, or Crohn's disease. 6.Patients with severe underlying diseases or malignancies in vital organs such as the heart, lungs, brain, and kidneys; 7.Individuals with mental disorders or other conditions who cannot participate in clinical research; 8.use of NSAIDs and other similar drugs (e.g. glucocorticoids) within 2 weeks before trial entry;

Design outcomes

Primary

MeasureTime frame
The incidence of early persistent organ failure, defined as the absence of organ failure before randomization , with new-onset organ failure occurring within 7 days after randomization and lasting>48;

Secondary

MeasureTime frame
Incidence of infected pancreatic necrosis;Case fatality rate;new-onset renal failure;New-onset respiratory failure;CT Pancreatic Severity Index;SIRS grade;safety endpoint;APACHEII score;Follow-up for 6 months;Intra-abdominal hemorrhage;Sepsis;Intensive care time;hospitalization expenses;Serum inflammatory markers;New-onset circulatory failure;total length of stay;acute gastrointestinal injury (AGI) score;Portal vein system thrombosis;Gastrointestinal fistula:;

Countries

China

Contacts

Public ContactWenhua He

The first affiliated hostipal of nanchang university

hewenhua@ncu.edu.cn+86 138 7918 2642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026