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

University Hospital Center (CHU)

Status

Active, not recruiting

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Procedure: minimally invasive distal pancreatectomy

Procedure: open distal pancreatectomy

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT04483726

RECHMPL19_0340

Details and patient eligibility

About

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

Full description

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 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

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 years;
Elective indication for distal pancreatectomy for proven or suspected PDAC;
Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail;
The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team;
The patient is fit to undergo both open and minimally invasive distal pancreatectomy

Exclusion criteria

score of American society of anaesthesiologists (ASA) >3;
A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);
Second malignancy necessitating resection during the same procedure;
Distant metastases (M1) including involved distant lymph nodes;
Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein);
Pregnancy;
Participation in another study with interference of study outcomes.
Cystic lesion having undergone malignant transformation
- the celiac trunk should be 5mm clear from tumor