DIPLOMA trial version 1.0
Research type
Research Study
Full title
Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA)\nA pan-European, randomised controlled, multicentre, patient blinded, non-inferiority trial.
IRAS ID
232201
Contact name
Mikayala King
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN44897265
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Does minimally invasive or open surgery for cancer in the body or tail of the pancreas provide similar oncological efficiency (i.e radicality)?\nCancer in the body or tail of the pancreas (distal pancreas) is a devastating disease with, after intended curative treatment, only 20% of the patients alive after 5 years. Surgery is the only potentially curative treatment. The standard method by which this surgery is performed is through a large abdominal incision. Although the care around operations and oncological treatment strategies are improving, this invasive operation comes with a high rate of major complications (30%) and mortality (3-5%). \nIncreasingly the minimally invasive or keyhole approach is advocated as resulting in less pain after surgery, better cosmesis and a quicker recovery. For benign and premalignant disease of the distal pancreas minimally invasive surgery is considered standard. However, for cancer to date there is a lack of good quality evidence to support the use of minimally invasive surgery over the traditional open approach. Especially similar oncological safety (i.e radicality) is not yet clearly demonstrated in a randomised trial. \nAt this moment a substantial amount of patients with pancreatic cancer does not receive minimally invasive surgery and is potentially not benefiting from shorter time to recovery and better quality of life (QOL). The proposed research trial will address this knowledge gap.\nThis trial aims to compare oncological safety (i.e. radicality), time to functional recovery, Quality of Life, survival and costs after minimally invasive or open surgery for cancer in the distal pancreas (distal pancreatectomy). Patients will be allocated by randomisation to one of the two surgical approaches. The research will be carried out in multiple centres in the UK and the rest of Europe capable of performing such specialist surgery.\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
18/SW/0047
Date of REC Opinion
20 Feb 2018
REC opinion
Favourable Opinion