Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO)

Completed

• Conditions: 10019818; biliary pancreatitis; 10015674; 10004606

• Registration Number: NL-OMON36818
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-02-18
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

- age 18 years or older
- mild (non-severe) biliary pancreatitis, without sterile pancreatic necrosis and/or peripancreatic collections.
- first episode of pancreatitis
- written and oral informed consent

Exclusion Criteria

- patients <18 years
- patients >75 years with ASA III
- ASA IV and V patients
- patients with history of alcohol abuse or chronic pancreatitis
- mild pancreatitis with sterile pancreatic necrosis and/or peripancreatic collections
- severe pancreatitis: persistent (>48hrs) organ failure or necrotizing pancreatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute re-admission for biliary events (recurrent biliary pancreatitis, acute<br /><br>cholecystitis,<br /><br>choledocholithiasis mandating ERCP or biliary colics).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- patient satisfaction, medical and indirect costs in terms of volumes of<br /><br>resource utilization in relation to outcome (cost-effectiveness analysis)<br /><br>- individual components of the primary endpoint: number of biliary colics after<br /><br>randomization, length<br /><br>of stay, difficulty of operation (VAS), duration and complications of<br /><br>cholecystectomy, conversion rate of laparoscopic to open<br /><br>cholecystectomy, length of stay, mortality.</p><br>