Clinical trial NCT04483726: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
Official title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreas
pancreatic
surgery
minimally-invasive
cancer
adenocarcinoma
laparoscopy
randomized
prospective
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: AIDS Malignancy Consortium
First posted: 2020-07-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Detailed 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 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

Eligibility criteria: 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

Primary outcomes:
measure: microscopically radical resection rate
timeFrame: 1 day
Secondary outcomes:
measure: survival
timeFrame: 1 year
measure: survival
timeFrame: 2 years
measure: survival
timeFrame: 3 years
measure: lymph node retrieval
timeFrame: 1 day
measure: Operative time
timeFrame: 1 day
measure: Intraoperative blood loss
timeFrame: 1 day
measure: intraoperative outcomes
timeFrame: 1 day
measure: postoperative outcomes
timeFrame: 1 day
measure: specimen size
timeFrame: 1 day
measure: Specimen length
timeFrame: 1 day
measure: margin
timeFrame: 1 day
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon - APHP
city: Montpellier
country: France
facility: CHU Saint Eloi - Montpellier
city: Orléans
country: France
facility: Centre Hospitalier Orléans
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
References: