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Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

ConditionsPancreatectomyDistal Pancreatectomy (DP)Pancreatic NeoplasmsPancreatic AdenomaPancreatic CystPancreatic CystadenomaSurgeryMinimally Invasive Surgical TechniqueMinimally Invasive Distal PancreatectomyMinimally Invasive Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at least 18 years;

Indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease);

Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team;

Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist;

Disqualifiers

Suspected pancreatic ductal adenocarcinoma;

Tumor or cyst larger than 8 cm;

Required resection or ablation of organs other than pancreas and spleen;

Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic minimally invasive left-sided pancreatecomy

    Procedure/Surgery

    Laparoscopic minimally invasive left-sided pancreatecomy

  • Robot-assisted minimally invasive left-sided pancreatecomy

    Procedure/Surgery

    Robot-assisted minimally invasive left-sided pancreatecomy

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Laparoscopic minimally invasive left-sided pancreatecomyActive comparator 1 intervention
Group B: Robot-assisted minimally invasive left-sided pancreatecomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

COMPOS-panc left score

The COMPOS-panc left score is a recently developed, severity-weighted composite outcome measure for pancreatic surgery. It combines perioperative and postoperative outcomes into a single composite outcome measure. This score includes the following parameters, measured at 90-days postoperative: unplanned blood transfusion, emergency conversion to open surgery, postoperative pancreatic fistula (POPF), postpancreatectomy hemorrhage (PPH), other complications requiring intervention, multi-organ failure, mortality, length of hospital stay and readmission requiring intervention.

Time frame
90 days

Secondary outcomes

1

Total hospital-related costs

To examine total hospital-related costs, the following costs will be considered up to 90 days postoperative: 1. Direct cost of the operation 2. Direct cost of the post-operative hospital stay 3. Direct cost of follow-up period, including readmission, outpatient visits, emergency room visits and reintervention

Time frame
90 days
2

Spleen-preservation rate and spleen-preservation technique

Compare L-MILP and R-MILP for spleen-preservation rate and spleen-reservation technique (Kimura versus Warshaw technique)

Time frame
Surgery
3

Pancreatic surgery specific complications

Complications including pancreatic fistula, delayed gastric emptying, postoperative bleeding, wound infection, other gastrointestinal leakage, re-interventions (radiographic, endoscopic, surgical), ICU admission, in hospital, 30- and 90-day mortality.

Time frame
90 days

Other outcomes

1

Operative outcomes

Total operative time (first skin incision to fully closed skin incisions, min.); Time of reconstruction phase; Estimated intraoperative blood loss (mL); Serious intraoperative complications; Conversion; Reason for conversion; Surgeon's mental strain (measured at the end of surgery).

Time frame
Surgery
2

Length of hospital stay

Days from surgery to discharge; Readmission rates; Total of hospitalized days.

Time frame
90 days postoperatively
3

Patient-reported outcomes

(Health-related) Quality of Life measurement using validated EORTC questionnaires: Baseline, 1-, 3-, 6- months and 1 year

Time frame
1 year postoperative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Leiden University Medical Center

Collaborator

Catharina Ziekenhuis Eindhoven

Collaborator

Erasmus Medical Center

Collaborator

Medisch Spectrum Twente

Collaborator

Maastricht University Medical Center

Collaborator

University Medical Center Groningen

Collaborator

Onze Lieve Vrouwe Gasthuis

Collaborator

Source ClinicalTrials.gov
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