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

Study Overview
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Brief Summary
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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
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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

Official Title
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Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: minimally invasive distal pancreatectomy
* Procedure: open distal pancreatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIDP<br>minimally invasive distal pancreatectomy | Procedure: minimally invasive distal pancreatectomy<br>* Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)<br>|
| Sham Comparator: ODP<br>open distal pancreatectomy | Procedure: open distal pancreatectomy<br>* open distal pancreatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microscopically radical resection rate | R0, >1mm | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | Date of death | 1 year | 
| survival | Date of death | 2 years | 
| survival | Date of death | 3 years | 
| lymph node retrieval | Tumor positive lymph nodes retrieved | 1 day | 
| Operative time | Operative time from first incision to closure of the abdomen, minutes | 1 day | 
| Intraoperative blood loss | Intraoperative blood loss, mL (suction canister and weight of gauzes) | 1 day | 
| intraoperative outcomes | Total duration of the procedure, minutes | 1 day | 
| postoperative outcomes | Major complications | 1 day | 
| specimen size | Tumor size, mm | 1 day | 
| Specimen length | Specimen length, mm | 1 day | 
| margin | Distance from tumor to transection, anterior and posterior margin, mm | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas, pancreatic, surgery, minimally-invasive, cancer, adenocarcinoma, laparoscopy, randomized, prospective