DISPACT-2
Research type
Research Study
Full title
Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial).
IRAS ID
291146
Contact name
Christopher Halloran
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
DRKS00014011, DRKS website
Duration of Study in the UK
4 years, 7 months, 30 days
Research summary
Resections of the pancreas which reach to the left of the superior mesenteric vein are defined as distal pancreatectomy and are undertaken for potential or actual malignant lesions of this portion of the pancreas. Open surgery has been considered the gold standard, however laparoscopic approaches are becoming more mainstream.
This study will evaluate potential differences in clinical and oncological effectiveness, safety, quality of life and costs between minimal-invasive and open distal pancreatectomy. The primary hypothesis is that minimal-invasive, i.e. laparoscopic distal pancreatectomy (LDP) is non-inferior to open distal pancreatectomy (ODP) in terms of postoperative mortality and
morbidity measured as the comprehensive complication index (CCI) within 3 months after intervention.Eligible patients would be those: Undergoing planned distal pancreatectomy with or without
splenectomy for any indication; Patient suitable for both surgical techniques; Age ≥ 18 years; Ability of subject to understand character and individual consequences of the clinical trial and be able to undertake written informed consent.This is a Pan-Germany study with Liverpool as the only UK site, selected because of high volume of pancreas surgery. The study will recruit over 2 year with follow-up of 2 years.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0278
Date of REC Opinion
9 Dec 2021
REC opinion
Further Information Favourable Opinion