To compare MIDP with ODP regarding radical resection rate) for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Ductaal adenocarcinoom van het pancreas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is microscopically radical resection margins (R0) (these
can be in the transection margin of the pancreas but also in the anterior,
superior, posterior, inferior margins, i.e. circumferential margins).
Secondary outcome
Secundary endpoints are:
- Intraoperative parameters (operative time, blood loss, blood transfusion and
conversion)
- Postoperative parameters (complications, mortality, re-interventions)
- Pathology parameters (tumor size, lymph node retrieval, positive nodes,
invasion, grading and staging)
- Hospitalization parameters (time to functional recovery, tot hospital sta,
readmission, intensive care admission)
- Oncology parameters (use of (neo-)adjuvant chemotherapy
- Quality of life
- Costs
Background summary
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 specifically regarding the oncologic safety (i.e. radical
resection, lymph node retrieval and survival) of MIDP in pancreatic cancer.
Most surgeons stated that a randomised trial assessing oncologic safety in MIDP
vs ODP for pancreatic cancer is needed.
Study 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, randomised controlled, multicentre, patient-blinded
non-inferiority trial. This protocol was designed according to the SPIRIT
guidelines1.
Intervention
Minimally invasive (laparoscopic or robot) distal pancreatectomy
Study burden and risks
Recent meta-analyses of cohort studies suggest that MIDP is superior to ODP
concerning blood loss, complications and hospital stay but data are lacking on
oncologic outcomes after MIDP. Subjects will not undergo additional
investigations and interventions due to participation in the DIPLOMA trial and
therefore risks to subjects involved in this trial are similar to every other
patient undergoing distal pancreatectomy in routine clinical practice.
Potential benefits for subjects in the investigational treatment arm could be
less intraoperative blood loss, fewer major complications, expedited functional
recovery, a shorter hospital stay and better cosmesis.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age equal or above 18 years;
Indication for elective distal pancreatectomy for expected PDAC;
Upfront (without induction / down-sizing radio- or chemotherapy) resectable PDAC in the pancreatic body or tail;
The tumour can be radically resected via both minimally invasive or open surgery according to the local treating team;
The patient is fit to undergo distal pancreatectomy, either minimally invasive or open
Exclusion criteria
ASA-score >3
History of chronic pancreatitis
Surgery for secondary tumour
Distant metastases (M1)
Tumour involvement of major vessels
Pregnancy
Participation in study with interference of study outcomes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63299.018.17 |