Clinical Trial

Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

Study acronym: PANDREAS
Not Yet Recruiting
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Summary
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.
Trial Details
NCT Number NCT06141044
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Conditions Postoperative Pancreatic Fistula, Distal Pancreatectomy, Drainage
Enrollment 104 participants
Start Date 2024-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2023-11-21