Pancreatic Ductal AdenocarcinomaDIPLOMANCT04483726
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
A study testing minimally invasive distal pancreatectomy and open distal pancreatectomy in people with Pancreatic Ductal Adenocarcinoma, run by University Hospital, Montpellier at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- minimally invasive distal pancreatectomy and open distal pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Jul 2020to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 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
Who cannot join
- 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;
Show all 9Show fewer
- Participation in another study with interference of study outcomes.
- Cystic lesion having undergone malignant transformation
- the celiac trunk should be 5mm clear from tumor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Beaujon - APHP
Clichy
CHU Saint Eloi - Montpellier
Montpellier
Centre Hospitalier Orléans
Orléans
Institut Mutualiste Montsouris
Paris
Hôpital Paul Brousse
Villejuif
About this study
Official title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
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.
Read more
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
Read the 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
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- minimally invasive distal pancreatectomy, open distal pancreatectomy
- Keywords
- pancreas, pancreatic, surgery, minimally-invasive, cancer, adenocarcinoma, laparoscopy, randomized, prospective
- Medical subject headings
- Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive distal pancreatectomyProcedure or surgery
Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
open distal pancreatectomyProcedure or surgery
open distal pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| MIDP | Experimental | minimally invasive distal pancreatectomy Receives: Procedure: minimally invasive distal pancreatectomy |
| ODP | Sham comparator | open distal pancreatectomy Receives: Procedure: open distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
microscopically radical resection rate
R0, >1mm
Measured: 1 day
Secondary outcomes (11)
survival
Date of death
Measured: 1 year
survival
Date of death
Measured: 2 years
survival
Date of death
Measured: 3 years
lymph node retrieval
Tumor positive lymph nodes retrieved
Measured: 1 day
Operative time
Operative time from first incision to closure of the abdomen, minutes
Measured: 1 day
Intraoperative blood loss
Intraoperative blood loss, mL (suction canister and weight of gauzes)
Measured: 1 day
intraoperative outcomes
Total duration of the procedure, minutes
Measured: 1 day
postoperative outcomes
Major complications
Measured: 1 day
specimen size
Tumor size, mm
Measured: 1 day
Specimen length
Specimen length, mm
Measured: 1 day
margin
Distance from tumor to transection, anterior and posterior margin, mm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start9 Jul 2020
- Primary completion29 Apr 2021
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- AIDS Malignancy Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483726
- Sponsor's protocol ID
- RECHMPL19_0340
- Acronym
- DIPLOMA
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04483726
- Acronym / sponsor ID
- DIPLOMA / RECHMPL19_0340
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreas, pancreatic, surgery, minimally-invasive, cancer, adenocarcinoma, laparoscopy, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- AIDS Malignancy Consortium
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 23 Jul 2020 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIDP | Experimental | Procedure: minimally invasive distal pancreatectomyminimally invasive distal pancreatectomy |
| ODP | Sham comparator | Procedure: open distal pancreatectomyopen distal pancreatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (9 listed)
- 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);
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 |
|---|---|---|
| minimally invasive distal pancreatectomyMinimally invasive distal pancreatectomy (either laparoscopic or robot-assisted) | Procedure or surgery | MIDP |
| open distal pancreatectomyopen distal pancreatectomy | Procedure or surgery | ODP |
Primary outcome
microscopically radical resection rate
Time frame: 1 day
R0, >1mm
11 secondary outcomes
survival
Time frame: 1 year
survival
Time frame: 2 years
survival
Time frame: 3 years
lymph node retrieval
Time frame: 1 day
Operative time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
intraoperative outcomes
Time frame: 1 day
postoperative outcomes
Time frame: 1 day
specimen size
Time frame: 1 day
Specimen length
Time frame: 1 day
margin
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive distal pancreatectomy and open distal pancreatectomy in people with Pancreatic Ductal Adenocarcinoma, run by University Hospital, Montpellier at 5 sites in France.
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 9 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microscopically radical resection rate (time frame: 1 day). 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 22 Jun 2026.