Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a binational multicenter randomized controlled trial

Not Applicable

Completed

• Conditions: <p>Ductal adenocarcinoma, mucinous cystic neoplasm, intraductal papillary mucinous neoplasm, neuroendocrine tumor, solid-pseudopapillary neoplasms, chronic pancreatitis.</p>; Pancreatic lesions; 10019818

• Registration Number: NL-OMON28212
• Lead Sponsor: Ethicon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 282

Inclusion Criteria

Elective distal pancreatectomy, >18 years of age, all indications, all approaches (open, laparoscopic, robotic).

Exclusion Criteria

Pregnancy, DP as a secondary procedure during gastric or colonic resection, Colonic resection required for cancer extension (gastric resection allowed), Participation to another study with interference with study outcome;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the rate of Clavien-Dindo score = 3 complications</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are grade B/C POPF, re-operation, catheter drainage, abdominal collections, wound infection, DGE, PPH, blood transfusion, length of stay (LOS), in-hospital mortality, 30-day mortality, 90-day mortality, readmission within 30 days, start of adjuvant chemotherapy.</p><br>