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Minimally Invasive versus Open Pancreatoduodenectomy for Resectable Neoplasms
Nine de Graaf1,2,3, Anouk M L H Emmen1,2,3, Marco Ramera3,4
1Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Background:
Minimally invasive pancreatoduodenectomy (MIPD) might accelerate postoperative recovery in patients with primary resectable neoplasm compared with open pancreatoduodenectomy (OPD), although the safety of MIPD remains debated. We aimed to assess whether MIPD is noninferior to OPD for overall complications and superior for time to functional recovery (TTFR).
Methods:
We conducted an international, multicenter, patient-blinded randomized noninferiority trial in patients undergoing pancreatoduodenectomy for primary resectable pancreatic and periampullary neoplasm from high-volume centers. Patients were randomly assigned in a 2:1 ratio to undergo robot-assisted or laparoscopic MIPD versus OPD and were blinded to the procedure until postoperative day 5. The primary end point was overall complications within 90 days of surgery, as measured using the Comprehensive Complication Index (range 0-100, with higher scores indicating more severe complications). Noninferiority was tested using a margin of -7.5 points (one-sided 97.5% confidence interval [CI]; P<0.025 for noninferiority). The main secondary end point was TTFR, tested for superiority. Analyses were reported by the intention-to-treat principle.
Results:
Overall, 288 patients were randomly assigned (190 MIPD [170 robot-assisted, 20 laparoscopic] and 98 OPD) in 14 centers. The mean Comprehensive Complication Index was 33.4±27.5 in the MIPD group versus 35.3±25.5 in the OPD group (mean difference, -1.9; 95% CI, -8.5 to 4.7; P=0.002 for nonferiority). In the MIPD group, the median TTFR was 7 days (95% CI, 6 to 8) versus 8 days (95% CI, 7 to 11) in the OPD group. The MIPD conversion rate to open surgery was 8.4%. Rates of postoperative pancreatic fistula were 22.6% versus 35.7% (relative risk 0.63; 95% CI, 0.43 to 0.91) and were 12.6% versus 22.7% (relative risk 0.57; 95% CI, 0.32 to 0.98) for surgical site infection after MIPD and OPD, respectively. Death by 90 days occurred in 4.7% of patients after MIPD versus 2.0% after OPD (relative risk 2.40; 95% CI, 0.51 to 11.30).
Conclusions:
In patients with resectable pancreatic and periampullary neoplasm, MIPD was noninferior to OPD for 90-day overall complications (Funded by Intuitive Surgical and Fondazione Poliambulanza Istituto Ospedaliero; International Standard Randomised Controlled Trial Number Registry, ISRCTN27483786.).
Insights
Minimally invasive pancreatoduodenectomy (MIPD) is noninferior to open pancreatoduodenectomy (OPD) for overall complications in patients with resectable pancreatic cancer. MIPD also demonstrated a faster time to functional recovery, suggesting improved patient outcomes.
Area of Science:
- Surgical Oncology
- Gastroenterology
- Minimally Invasive Surgery
Background:
- Minimally invasive pancreatoduodenectomy (MIPD) may offer faster recovery than open pancreatoduodenectomy (OPD) for resectable pancreatic neoplasms.
- The safety and efficacy of MIPD compared to OPD remain under investigation.
Purpose of the Study:
- To determine if MIPD is noninferior to OPD regarding overall complications.
- To assess if MIPD is superior to OPD in terms of time to functional recovery (TTFR).
Main Methods:
- An international, multicenter, patient-blinded randomized noninferiority trial compared robot-assisted/laparoscopic MIPD with OPD.
- 288 patients with resectable pancreatic or periampullary neoplasms were randomized (2:1 ratio).
- Primary endpoint: overall complications within 90 days (Comprehensive Complication Index); Secondary endpoint: TTFR.
Main Results:
- MIPD was noninferior to OPD (mean CCI: 33.4 vs 35.3, P=0.002).
- Median TTFR was shorter for MIPD (7 days) versus OPD (8 days).
- MIPD showed lower rates of pancreatic fistula and surgical site infection, but a higher 90-day mortality rate (4.7% vs 2.0%).
Conclusions:
- Minimally invasive pancreatoduodenectomy is noninferior to open pancreatoduodenectomy for 90-day overall complications in patients with resectable pancreatic and periampullary neoplasms.
