To compare L-MILP with R-MILP for benign and pre-malignant lesions of the pancreas in high-volume centers, regarding:1. Peri- and postoperative outcomes in terms of COMPOS-panc left score, for non-inferiority2. Total hospital-related costs, for…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the COMPOS-panc left score, which combines perioperative
and postoperative outcomes into a single, severity-weighted outcome. 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.
Secondary outcome
The most relevant secondary endpoint is total hospital-related costs and
includes analyses of the direct cost of the operation, the direct cost of the
post-operative hospital period and the total cost of the follow-up period,
including readmission, outpatient visits, emergency room visits and
reintervention up to 90-days postoperative.
Other secondary endpoints are intra-operative outcomes (e.g. type of
left-pancreatectomy (LP), blood loss, operative time, conversion, method of
pancreatic transection, spleen-preservation rate, Kimura/Warshaw technique,
vascular resection, extended resection), postoperative pain, post-operative
morbidity (e.g. Clavien-Dindo scores, surgical site infection (SSI),
non-surgical complications, pancreatic surgery specific complications according
to ISGPS definitions), ideal outcome, health-care resource utilization (e.g.
ICU stay), surgeon*s mental and physical strain and quality of life.
Background summary
Minimally invasive left-sided pancreatectomy (MILP) is currently the
recommended approach for treatment of benign and low-grade malignant lesions of
the pancreas, showing favorable outcomes over open left-sided pancreatectomy
(OLP). Robot-assisted MILP (R-MILP) is slowly gaining popularity because of
potential intraoperative technical advantages, such as 3D visualization and
improved dexterity, possibly contributing to lower postoperative morbidity.
However, multiple studies have shown an increase in costs when R-MILP is
compared with laparoscopic MILP (L-MILP). Moreover, L-MILP and R-MILP have
shown comparable morbidity and mortality in multiple retrospective studies,
raising the question if the use of R-MILP over L-MILP is justifiable
considering these increasing costs. Yet, no randomized controlled trials (RCTs)
have compared clinical outcomes after L-MILP and R-MILP. Furthermore, such
studies could determine whether L-MILP is more cost-effective then R-MILP.
Study objective
To compare L-MILP with R-MILP for benign and pre-malignant lesions of the
pancreas in high-volume centers, regarding:
1. Peri- and postoperative outcomes in terms of COMPOS-panc left score, for
non-inferiority
2. Total hospital-related costs, for superiority (for L-MILP)
3. Spleen-preservation rate, for superiority (for R-MILP)
Study design
An international multicenter patient-blinded randomized controlled trial in
high-volume centers with a minimum experience of 85 minimally invasive
pancreatic resections (MIPR) and surgeons with a personal experience of at
least 30 MIPR, combining both left-sided pancreatectomy and
pancreatoduodenectomy (either laparoscopic or robot-assisted, depending on the
procedure they will be performing during the trial) can participate. Centers
can only participate if both R-MILP and L-MILP can be performed, to ensure
randomization within a center is possible. A blinded adjudication committee
will assess all endpoints. The protocol is designed according to the SPIRIT
guidelines.
Intervention
Minimally invasive, laparoscopic or robot-assisted, left-sided pancreatectomy
Study burden and risks
No additional risks are associated with participation in the DIPLOMA-3 trial.
Both laparoscopic and robotic left-sided pancreatectomy are currently part of
standard practice in high-volume experienced HPB centers. Both procedures have
shown similar peri- and postoperative outcomes in retrospective studies. The
only additional patient burden during the trial is the completion of quality of
life questionnaires at multiple timepoints pre- and postoperative.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age at least 18 years;
- Indication for elective left-sided pancreatectomy (either only tail,
body-tail, neck-body-tail, extended neck-body-tail), 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.
Exclusion criteria
- 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.
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 | NL88413.018.24 |