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Shannon et al. Mini-invasive Surg 2023;7:32 https://dx.doi.org/10.20517/2574-1225.2023.83 Page 9 of 15

Table 2. Ongoing clinical comparing minimally invasive and open pancreaticoduodenectomy
Year Anticipated
Trial name Groups Patient population Primary end point
registered completion date
NCT04211948 2019 2024 Robotic PD vs. OPD PDAC 1 and 3-year OS
MIOP- 2018 2028 MIPD vs. OPD Resectable PDAC, bile duct, 30-day complications
NCT03747588 ampullary cancer
PORTAL 2020 2022 Robotic PD vs. OPD Resectable PDAC, Time to functional
NCT04400357 periampullary cancer recovery
NCT04171440 2020 2024 Robotic PD Benign + malignant pancreas or Hospital LOS
periampullary lesion
NCT03785743 2019 2027 Laparoscopic PD vs. PDAC 5-year OS
OPD
NCT03138213 2018 2022 Laparoscopic PD vs. Periampullary cancer LOS
OPD
DIPLOMA-2 2022 2026 Robotic or Premalignant or malignant Safety and time to
ISRCTN27483786 laparoscopic PD vs. disease functional recovery
OPD

LOS: Length of stay; MIPD: minimally invasive pancreaticoduodenectomy; OPD: open pancreaticoduodenectomy; OS: overall survival; PD:
pancreaticoduodenectomy; PDAC: pancreatic ductal adenocarcinoma.

20-25 cases, whereas a separate study showed improved operative times and performance in 30 cases [102,103] .
One study found the number of cases needed to achieve proficiency in robotic PD was 40 . While the
[104]
“exact” number of cases needed to achieve proficiency is heavily dependent on a number of factors (surgeon
training, surgeon experience, operating room staff, etc.), intensive training programs focused on minimally
invasive techniques are crucial to overcome this learning curve [105-107] .

The extensive learning curve in minimally invasive pancreas surgery is due in part to the complexity of the
reconstruction. Methods of reconstruction and management of the pancreatic stump during minimally
invasive PD and DP, respectively, are crucial to reducing post-operative complications. Complications of
minimally invasive pancreas surgery are similar to those encountered in open approaches, namely
pancreatic leak or fistula, postpancreatectomy hemorrhage, anastomotic leak, bile leak, delayed gastric
emptying, and pancreatogenic diabetes. Yet, as discussed in the sections above, there is no convincing data
showing increased rates of complications or the need for further procedures to treat complications due to a
minimally invasive approach.

The actual approach for minimally invasive pancreatectomy can be executed in several ways, including total
laparoscopic or robotic alone, a hybrid approach where the robot is docked but in conjunction with a
bedside assistant using laparoscopic instruments, or a hand-assisted approach. The superiority of these
different techniques remains debatable and should depend on surgeon comfort and experience and various
patient factors such as body mass, pancreatic duct size, and firmness of the gland. As such, there has been
no definitive evidence to indicate a difference in pancreatic leak rate between any of these approaches [108,109] .
Minimally invasive DP has similar morbidity compared to open approaches, with the advantages of quicker
return to functional baseline, shorter hospital stay, and improved cosmetics. However, given the complexity
of reconstruction, the advantages of minimally invasive PD are fewer. Nevertheless, as the robotic platform
becomes more universally adopted and more commonly used, the technical acumen of surgeons to perform
this complex surgery will increase, potentially leading to improved outcomes in the future for carefully
selected patients.