Minimally Invasive Pancreatoduodenectomy Noninferior to Open Surgery: Study Finds
Netherlands: A randomized noninferiority trial has found that minimally invasive pancreatoduodenectomy (MIPD) was noninferior to open pancreatoduodenectomy (OPD) for 90-day postoperative complications and offered a modestly faster functional recovery in patients with resectable pancreatic and periampullary tumors.
A new international trial published in NEJM Evidence has provided important insights into the comparative safety and recovery outcomes of minimally invasive versus open pancreatoduodenectomy for resectable pancreatic and periampullary neoplasms.
Led by Nine de Graaf and colleagues from the Department of Surgery at Amsterdam UMC, University of Amsterdam, the study addresses long-standing concerns regarding the safety profile of MIPD, while evaluating its potential to improve postoperative recovery.
Minimally invasive approaches have gained popularity in recent years due to their potential benefits in reducing surgical trauma and hastening recovery. However, their use in pancreatoduodenectomy—one of the most complex abdominal surgeries—has remained highly debated, with questions surrounding complication rates and overall safety. To provide clarity, the researchers designed a patient-blinded, multicenter, randomized noninferiority trial across 14 high-volume hospitals.
A total of 288 patients with primary resectable pancreatic or periampullary neoplasms were enrolled and randomly assigned in a 2:1 ratio to undergo either minimally invasive (robot-assisted or laparoscopic) pancreatoduodenectomy or the traditional open procedure. Importantly, patients remained blinded to their allocated surgical method until the fifth postoperative day, minimizing bias in the assessment of recovery.
The study’s primary endpoint was the overall complication burden within 90 days after surgery, measured using the Comprehensive Complication Index (CCI), where higher scores indicate more severe complications. The investigators predefined a noninferiority margin of –7.5 points and conducted analyses based on the intention-to-treat principle.
The study led to the following findings:
- The mean Comprehensive Complication Index was 33.4 in the MIPD group compared with 35.3 in the OPD group.
- The mean difference of 1.9 points met the criteria for noninferiority, showing that MIPD did not increase the overall complication burden compared with OPD.
- Patients undergoing MIPD achieved functional recovery sooner, with a median of 7 days versus 8 days in the OPD group.
- The conversion rate from minimally invasive to open surgery was 8.4%, indicating good feasibility of the minimally invasive approach.
- Postoperative pancreatic fistula occurred less frequently after MIPD (22.6%) compared with OPD (35.7%).
- Surgical site infections were also lower with MIPD (12.6%) than with OPD (22.7%).
- Ninety-day mortality was 4.7% in the MIPD group compared with 2.0% in the OPD group, although this difference was not statistically significant due to the wide confidence interval.
"Overall, the study provides robust evidence that minimally invasive pancreatoduodenectomy is a safe alternative to the open approach for appropriately selected patients. With comparable complication rates and faster recovery, MIPD may offer meaningful advantages as surgical expertise in this technique continues to expand," the authors concluded.
Reference:
DOI: 10.1056/EVIDoa2500045
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