Page 12 - Read Online

Page 6 of 15 Shannon et al. Mini-invasive Surg 2023;7:32 https://dx.doi.org/10.20517/2574-1225.2023.83

with PDAC. This international randomized controlled, patient- and pathologist-blinded trial aims to enroll
258 patients to examine the primary outcome of negative microscopic resection margin (R0) and secondary
outcome of survival following DP for PDAC. Results are still pending, with anticipated trial completion in
[31]
2025 .

Two multicenter prospective randomized controlled trials in Asia are currently recruiting in Korea
(NCT03957135) and China (NCT03792932). Both studies include patients with malignant pancreatic
tumors of the body or tail and will be randomized to laparoscopic or open DP. The primary outcomes of
these trials are two-year overall (Korea) and two-year disease-free (China) survival, with results expected in
2024-2025 .
[68]

The DISPACT-2 is a German multicenter randomized controlled trial comparing minimally invasive
(laparoscopic or robotic-assisted) and open DP for benign or malignant disease. The primary outcome is
post-operative mortality and morbidity within three months post-operatively. Secondary outcomes include
pancreatic-specific complications, oncologic outcomes, and patient-reported outcomes. Results are expected
in 2024 .
[69]
An ongoing multicenter randomized clinical trial by Dai et al., the MIRROR trial (NCT03770559), is
assessing the safety and efficacy of minimally invasive RAMPS by examining factors such as LOS, short-
[70]
term outcomes, and survival . A group from China is currently investigating robotic RAMPS vs. standard
RAMPS for PDAC. In this randomized single-center trial, the investigators will assess rates of R0 resection,
the number of lymph nodes harvested, perioperative complications, the duration of surgery, cost, and blood
loss . A list of ongoing trials comparing minimally invasive and open DP is shown in Table 1.
[71]
Recent trials on minimally invasive pancreaticoduodenectomy
Completed trials
Minimally invasive PD was less readily adopted than DP in part due to the complex reconstruction. There
have been many studies comparing minimally invasive to open PD. A recent randomized controlled trial in
2021 by Wang et al. compared outcomes from 14 medical centers in 762 patients undergoing laparoscopic
and open PD for pancreatic or periampullary tumors . The primary outcome was post-operative LOS,
[72]
which was significantly shorter for patients undergoing laparoscopic PD (laparoscopic LOS 15 days vs. open
LOS 16 days). There was no difference in serious post-operative morbidities or comprehensive complication
index scores between the two groups. The authors concluded that in high-volume centers, laparoscopic PD
was a safe and feasible procedure.

The PLOT trial was a single-center randomized controlled trial conducted in India between 2013 and 2015,
in which patients with peri-ampullary tumors were randomized to laparoscopic (n = 32) vs. open (n = 32)
PD. The initial primary outcome was the perioperative complication rate; however, this was changed at
interim analysis to the length of hospital stay in order to achieve an adequate sample size. Patients
undergoing laparoscopic PD had a significantly shorter hospital stay (13 vs. 7 days, P = 0.001) and
reduced blood loss but longer operative time compared to patients undergoing open PD. There was no
difference seen in post-operative complications or oncologic outcomes between the groups .
[73]
The PADULAP randomized controlled trial was completed in Spain between 2013 and 2017 and compared
perioperative outcomes of laparoscopic (n = 34) vs. open (n = 32) PD. Laparoscopic PD was associated with
shorter hospital LOS (median 13.5 vs. 17 days), longer operative time, and decreased complication rates (all
P < 0.05). There was no significant difference seen in pancreas-specific complications, the number of lymph