PancreatectomyDIPLOMA-3NCT06939023
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
A study testing Laparoscopic minimally invasive left-sided pancreatecomy and Robot-assisted minimally invasive left-sided pancreatecomy in people with Pancreatectomy and Distal Pancreatectomy (DP), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Distal Pancreatectomy (DP), Pancreatic Neoplasms
- What is being tested?
- Laparoscopic minimally invasive left-sided pancreatecomy and Robot-assisted minimally invasive left-sided pancreatecomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Written informed consent
Who cannot join
- 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);
- Pregnancy;
- Body mass index >40 kg/m2;
- Participation in another study with interference of study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte Baggerman van Houweninge, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Besselink, 0031618037377, c.e.baggermanvanhouweninge@amsterdamumc.nl
About this study
Official title: Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled 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.
- Conditions
- Pancreatectomy, Distal Pancreatectomy (DP), Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cyst, Pancreatic Cystadenoma
- Being tested
- Laparoscopic minimally invasive left-sided pancreatecomy, Robot-assisted minimally invasive left-sided pancreatecomy
- Keywords
- pancreas surgery, left-sided pancreatectomy, distal pancreatectomy, minimally invasive surgery, robot-assisted pancreatectomy, left pancreatectomy, robotic pancreatectomy, laparoscopic pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic adenoma, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic minimally invasive left-sided pancreatecomyProcedure or surgery
Laparoscopic minimally invasive left-sided pancreatecomy
Robot-assisted minimally invasive left-sided pancreatecomyProcedure or surgery
Robot-assisted minimally invasive left-sided pancreatecomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic minimally invasive left-sided pancreatecomy | Active comparator | Laparoscopic minimally invasive left-sided pancreatecomy Receives: Procedure: Laparoscopic minimally invasive left-sided pancreatecomy |
| Robot-assisted minimally invasive left-sided pancreatecomy | Experimental | Robot-assisted minimally invasive left-sided pancreatecomy Receives: Procedure: Robot-assisted minimally invasive left-sided pancreatecomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
Total hospital-related costs
To examine total hospital-related costs, the following costs will be considered up to 90 days postoperative:
- Direct cost of the operation
- Direct cost of the post-operative hospital stay
- Direct cost of follow-up period, including readmission, outpatient visits, emergency room visits and reintervention
Measured: 90 days
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)
Measured: Surgery
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Medisch Spectrum Twente, Maastricht University Medical Center, University Medical Center Groningen, Onze Lieve Vrouwe Gasthuis
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Prof. Mohammad Abu Hilal, MD PhD, Principal investigator, University of JordanProf. Marc Besselink, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939023
- Sponsor's protocol ID
- NL88413.018.24
- Acronym
- DIPLOMA-3
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06939023
- Acronym / sponsor ID
- DIPLOMA-3 / NL88413.018.24
- Conditions
- Pancreatectomy, Distal Pancreatectomy (DP), Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cyst, Pancreatic Cystadenoma
- Keywords
- pancreas surgery, left-sided pancreatectomy, distal pancreatectomy, minimally invasive surgery, robot-assisted pancreatectomy, left pancreatectomy, robotic pancreatectomy, laparoscopic pancreatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Leiden University Medical Center, Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Medisch Spectrum Twente, Maastricht University Medical Center, University Medical Center Groningen, Onze Lieve Vrouwe Gasthuis
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic minimally invasive left-sided pancreatecomy | Active comparator | Procedure: Laparoscopic minimally invasive left-sided pancreatecomyLaparoscopic minimally invasive left-sided pancreatecomy |
| Robot-assisted minimally invasive left-sided pancreatecomy | Experimental | Procedure: Robot-assisted minimally invasive left-sided pancreatecomyRobot-assisted minimally invasive left-sided pancreatecomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Written informed consent
Key exclusion criteria (7 listed)
- 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);
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic minimally invasive left-sided pancreatecomyLaparoscopic minimally invasive left-sided pancreatecomy | Procedure or surgery | Laparoscopic minimally invasive left-sided pancreatecomy |
| Robot-assisted minimally invasive left-sided pancreatecomyRobot-assisted minimally invasive left-sided pancreatecomy | Procedure or surgery | Robot-assisted minimally invasive left-sided pancreatecomy |
Primary outcome
COMPOS-panc left score
Time frame: 90 days
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.
3 secondary outcomes
Total hospital-related costs
Time frame: 90 days
Spleen-preservation rate and spleen-preservation technique
Time frame: Surgery
Pancreatic surgery specific complications
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Baggerman van Houweninge, MD contact
Prof. Mohammad Abu Hilal, MD PhD principal investigator
University of Jordan
Prof. Marc Besselink, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic minimally invasive left-sided pancreatecomy and Robot-assisted minimally invasive left-sided pancreatecomy in people with Pancreatectomy and Distal Pancreatectomy (DP), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Baggerman van Houweninge, MD (+31618037377, c.e.baggermanvanhouweninge@amsterdamUMC.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPOS-panc left score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.