Health Condition 1: K859- Acute pancreatitis, unspecified
Conditions
Interventions
Intervention1: Early endoscopic intervention in infected necrotizing pancreatitis: In the early treatment group, EUS-guided drainage is undertaken within 72 hours of randomization. In case of no clini
Sponsors
Orlando Health, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age 18 years or older. 2 Patients with symptomatic necrotic collection diagnosed on MRI or CT abdomen/pelvis, defined as a fluid collection in the setting of documented pancreatic necrosis containing necrotic material and surrounded by a partial or complete wall. 3 Documented or suspected infected necrotizing pancreatitis. 3.1 Documented infected necrotizing pancreatitis defined as: a. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection if intervention is undertaken within 14 days of onset of acute pancreatitis. OR b. Presence of gas in the necrotic collection on imaging at any time. 3.2 Suspected infected necrotizing pancreatitis if more than 14 days after onset of disease defined as: a. Persistent organ failure in patients admitted to ICU. OR b. Presence of at least three of the following six clinical or laboratory parameters with no other focus of infection: i. Temperature more than 100.4 F or less than 96.8 F. ii. Heart rate more than 90 beats per minute. iii. Respiratory rate more than 20 breaths per minute or PaCO2 less than 32 mmHg. iv. WBC count more than 12000/mm3 or less than 4000/mm3 or more than 10 percent immature band cells. v. CRP 30 mg/L or more. vi. Procalcitonin 1 ng/mL or more. 4 Endoscopic drainage of the necrotic collection is technically feasible as determined by the treating physician.
Exclusion criteria
Exclusion criteria: 1 Age less than 18 years. 2 More than 26 days after onset of acute pancreatitis. 3 Indication for emergency laparotomy for abdominal catastrophe including bleeding, bowel perforation, or abdominal compartment syndrome. 4 Necrotic collection not amenable to endoscopic intervention. 5 Pregnancy. 6 Inability to obtain informed consent from the patient or legally authorized representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of major complications or deathTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| MortalityTimepoint: 6 months;Major complicationsTimepoint: 6 months;New onset single and multiple organ failureTimepoint: 6 months;New onset systemic dysfunctionTimepoint: 6 months;Enterocutaneous and pancreatic fistulaTimepoint: 6 months;Intraabdominal bleedingTimepoint: 6 monthts;Visceral perforationTimepoint: 6 months;Incisional herniaTimepoint: 6 months;Surgical site infectionTimepoint: 6 months;New onset diabetesTimepoint: 6 months;New diagnosis of exocrine pancreatic insufficiencyTimepoint: 6 months;Procedure-related adverse eventsTimepoint: 6 months;Disease-related adverse eventsTimepoint: 6 months;Number of interventionsTimepoint: 6 months;Length of hospitalizationTimepoint: 6 months;ReadmissionsTimepoint: 6 months;Presence of systemic inflammatory response syndrome (SIRS) at 72 hours post-index interventionTimepoint: 72 hours;New onset systemic inflammatory response syndrome (SIRS) at 72 hours post-index interventionTimepoint: 72 hours;Resolution and improvement of systemic inflammatory response syndrome (SIRS) at 72 hours post-index interventionTimepoint: 72 hours;Technical successTimepoint: 6 months;Treatment successTimepoint: 6 months;Health-related quality of life (HRQoL)Timepoint: 6 months;Overall treatment costsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Panchal Hiteshbhai Bhikhabhai
Medanta The Medicity
Outcome results
None listed