PENGUIN-trial: pancreatitis, endoscopic transgastric versus primary necrosectomy in patients with infected necrosis. A randomised controlled multicenter observer-blinded trial

Completed

• Conditions: Infection of pancreas; pancreatitis; 10017969

• Registration Number: NL-OMON33864
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Age equal to or above 18 years
- Pancreatic necrosis or peripancreatic necrosis detected on CECT.
- Patients in whom a decision for surgical intervention has been made because of
(suspected) infected (peri-)pancreatic necrosis
- Safe access route for endoscopic transgastric necrosectomy
- Written informed consent

Exclusion Criteria

- Participation in another intervention trial that would interfere with the intervention and outcome of this study
- Previous surgical necrosectomy for (suspected) infected pancreatic necrosis,
Including procedures performed in referring hospitals. Previous percutaneous or
transgastric drainage is allowed.
- Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis
during laparotomy
- Acute flare-up of chronic pancreatitis
- Bleeding, abdominal compartment syndrome or perforation of a visceral organ as
indication for intervention
- Post-abdominal surgery necrotizing pancreatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the total pro-inflammatory response as measured by the<br /><br>maximum increase in level of serum cytokine IL-6 in the period between start of<br /><br>the first necrosectomy and five hours thereafter.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are complications (bleeding, perforation, pancreatic<br /><br>fistula,<br /><br>pancreatic pseudocyst requiring intervention, pancreatic abscess requiring<br /><br>intervention, biliary strictures, incisional hernia requiring re-intervention<br /><br>and<br /><br>pancreatic insufficiency) and mortality, total number of interventions,<br /><br>hospital and<br /><br>intensive care stay.</p><br>