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Shannon et al. Mini-invasive Surg 2023;7:32 https://dx.doi.org/10.20517/2574-1225.2023.83 Page 7 of 15
Table 1. Ongoing clinical comparing minimally invasive and open distal pancreatectomy
Year Anticipated
Trial name Groups Patient population Primary end point
registered completion date
DIPLOMA 2018 2025 MIDP vs. ODP PDAC R0 resection rate
ISRCTN44897265
NCT03957135 2019 2025 Laparoscopic DP vs. Resectable PDAC body or tail 2-year OS
ODP
NCT03792932 2019 2023 Laparoscopic DP vs. Resectable PDAC body or tail 2-year RFS
ODP
DISPACT-2 2020 2024 MIDP vs. OPD Benign + malignant body or CCI 3 months post-
tail lesions operatively
MIRROR 2018 2024 MI-RAMPS vs. open Resectable PDAC body or tail Post-operative LOS
NCT03770559 RAMPS
CCI: Comprehensive complication index; DP: distal pancreatectomy; LOS: length of stay; MIDP: minimally invasive distal pancreatectomy; MI-
RAMPS: minimally invasive radical antegrade modular pancreatosplenectomy; ODP: open distal pancreatectomy; OS: overall survival; PDAC:
pancreatic ductal adenocarcinoma; RAMPS: radical antegrade modular pancreatosplenectomy; RFS: recurrence-free survival.
nodes retrieved, or resection margin status between the groups .
[74]
The LEOPARD 2 trial was published in 2019 and compared outcomes in minimally invasive PD vs. open
approach in a multicenter, patient-blinded, and randomized controlled trial. This trial was separated into
phase II and phase III, with the primary outcomes being safety and time to functional recovery, respectively.
Fifty patients underwent a laparoscopic PD, whereas 49 patients underwent an open PD. The trial was
prematurely terminated due to a difference in 90-day complication-related mortality (10% in laparoscopic
vs. 0% in open) between the groups, although this was reported to not be statistically significant. Median
time to functional recovery and pancreatic-specific and non-specific complication rates were comparable
between the two groups . Similar findings were seen in a 2023 meta-analysis by Yan et al., who again
[75]
showed no differences in serious complications (including pancreatic fistula, hemorrhage, and reoperation)
or harvested lymph nodes but did note shorter LOS at the expense of increased operative times .
[76]
As shown above, although there have been benefits in short-term outcomes such as hospital LOS and no
difference in oncologic or perioperative complications with minimally invasive approaches, there are
disadvantages, including longer operative times for laparoscopic PD, similar to DP [77-80] . This was validated
by 2020 and 2023 meta-analyses by Nickel et al. and Pfister et al., respectively [81,82] . Dembinski et al. showed
similar five-year overall and recurrence-free survival in patients undergoing laparoscopic PD vs. open PD.
However, they did observe a higher need for re-interventions among patients who underwent the
[83]
minimally invasive approach . Vandeputte et al. performed a propensity score-matched comparison of the
two techniques, which once again showed no difference in oncologic outcome. However, they did observe a
higher complication rate for the minimally invasive approach . Laparoscopic PD was associated with
[84]
[85]
increased rates of pneumonia and abdominal infections in a retrospective review . Taken together, further
prospective randomized trials are needed to address these conflicting data.
The advent of the robot has rapidly expanded the utilization of a minimally invasive approach for PD. This
may be due to the increased range of motion and dexterity of the robot to allow for easier reconstruction
and, thus, a more achievable learning curve. A 2022 propensity score-match study published in the Journal
of the American College of Surgeons showed longer operative times but less blood loss, LOS, and 30-day
[86]
readmission for patients undergoing robotic PD compared to open PD . van Oosten et al. found similar
findings in their cohort of robotic PD at John’s Hopkins . Other studies have shown fewer complications
[87]
and comparable oncologic outcomes for robotic PD compared to open, including a 2022 multi-institutional