The objective of the LEOPARD-2 trial is to assess the safety of MIPD versus OPD and after that to assess the time to functional recovery of MIPD versus OPD for symptomatic benign, premalignant or malignant peri-ampullary disease.
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Health condition
peri-ampullaire aandoeningen/tumoren/cysten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 2:
- IL-6 serum levels
Phase 3:
- Time to functional recovery, defined as: independently mobile (or as mobile
as preoperatively), adequate pain control with only oral analgesia, the ability
to maintain at least 50% of daily required caloric intake, no intravenous fluid
administration, no signs of active infection.
Secondary outcome
- Clavien-Dindo III or higher complications
- Individual complications
- Mortality
- Quality of life
- Costs
- Other operative outcomes
- Other postoperative outcomes
Background summary
Observational studies suggested that LPD versus OPD is associated with improved
outcomes, such as less operative blood loss, lower postoperative morbidity and
shorter length of hospital stay, without increasing costs. However, these
outcomes are obviously influenced by selection bias and case-matched studies
failed to show clear superior outcomes. A randomized controlled trial is
therefore indicated. First, the safety of LPD versus OPD has to be determined,
which is followed by assessing the potential advantages of LPD over OPD in a
large randomized controlled trial in high-volume centers.
Study objective
The objective of the LEOPARD-2 trial is to assess the safety of MIPD versus OPD
and after that to assess the time to functional recovery of MIPD versus OPD for
symptomatic benign, premalignant or malignant peri-ampullary disease.
Study design
A randomized controlled, parallel-group, pragmatic, patient-blinded, phase 2/4,
multicenter superiority study in high-volume centers of the Dutch Pancreatic
Cancer Group. The study protocol is designed according to the SPIRIT 2013
guidelines.
Intervention
Intervention: Minimally invasive pancreatoduodenectomy
Control: Open pancreatoduodenectomy
Study burden and risks
Recent meta-analyses of cohort studies suggested that LPD is superior to OPD
concerning operative blood loss, complications and length of hospital stay, but
these advantages were not seen in case-matched studies. Furthermore, LPD
appeared to be safe in the prospective series from the Dutch Pancreatic Cancer
Group, with comparable morbidity and mortality for LPD and OPD. The risks in
the LEOPARD-2 trial are comparable to the risks of every other patient
undergoing pancreatoduodenectomy in routine clinical practice. Potential
benefits for subjects in the investigational arm could be less operative 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 pancreatoduodenectomy because of a malignant, pre-malignant or symptomatic benign disease located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater
• The procedure can be performed both laparoscopically and open according to the local surgeon
• Fit to undergo pancreatoduodenectomy according to the surgeon and anaesthetist
Exclusion criteria
• A second cancer requiring resection during the same procedure
• Administration of neo-adjuvant radiotherapy
• Vascular involvement (portal vein, superior mesenteric vein, superior mesenteric artery or hepatic artery)
• Pregnancy
• Body mass index >35 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL54453.018.15 |
| OMON | NL-OMON22778 |