Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)

Active:	No
Cancer Type:	Pancreatic Cancer Unknown Primary	NCT ID:	NCT04483726
Trial Phases:		Protocol IDs:	RECHMPL19_0340 (primary) NCI-2022-02070
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	University Hospital, Montpellier
NCI Full Details:	http://clinicaltrials.gov/show/NCT04483726

Summary

Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal
adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded
non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs
ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective
distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or
robot-assisted)

Control: Open distal pancreatectomy

Objectives

Rationale: Several systematic reviews have suggested superior short term outcomes after
minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy
(ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European
survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic
safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic
cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs
ODP for pancreatic cancer is needed.

Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal
adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded
non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs
ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective
distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or
robot-assisted)

Control: Open distal pancreatectomy

Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, >1mm)
resection rate. Main secondary outcomes are survival, lymph node retrieval, intraoperative
outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as
complications, time to functional recovery and hospital stay) and quality of life

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.