Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers

Pancreaticoduodenectomy (PD) currently stands as the sole option for treating resectable pancreatic head cancer; however, the long-term post-operative survival quality of patients remains unpromising. According to statistics from international multicenter studies, the 5-year survival rate of patients post-surgery does not exceed 20%. The principal causes for the suboptimal survival quality are the high recurrence and metastasis tendencies of pancreatic cancer, along with its low sensitivity and poor response to the existing neoadjuvant therapy. In contrast to traditional PD, PD combined with the TRIANGLE procedure (expanded PD) enables more thorough resection, effectively addressing the early recurrence and metastasis issues of pancreatic cancer and holds significant potential in enhancing patients' long-term survival quality. Nevertheless, there exists no high-level clinical evidence regarding the improvement of short-term complications for this surgical approach. Simultaneously, minimally invasive pancreatic surgeries have been demonstrated in high-throughput pancreatic centers to improve patients' short-term quality of life, yet the effect on long-term prognosis remains ambiguous. Hence, our center innovatively proposes minimally invasive PD in combination with the TRIANGLE procedure for the treatment of resectable pancreatic cancer, with the aim of integrating the advantages of both intervention measures to improve patients' post-operative quality of life and long-term survival quality.

This research will carry out a randomized controlled trial on patients with resectable pancreatic cancer who are scheduled to undergo minimally invasive PD in six Chinese centers and two foreign centers, comparing the prognostic disparities between traditional PD and the expanded PD procedure. The primary outcome measure is the postoperative disease-free survival (DFS), defined as "the time from randomization to disease recurrence or death for any reason." The projected enrollment period is 15 months, and the follow-up duration is 3 years.

• the rate of microscopically complete margin clearance [Срок оценки: Intraoperative]
• the rate of microscopic margin clearance ≤ 0.1 cm [Срок оценки: Intraoperative]
• the rate of microscopic margin involvement (R1) resections [Срок оценки: Intraoperative]
• the rate of postoperative pancreatic fistula [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]
• the rate of postpancreatectomy haemorrhage [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]
• the rate of delayed gastric emptying [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]
• the rate of bile leakage [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]
• the rate of lymphatic fistula [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]
• the rate of diarrhoea [Срок оценки: Day of discharge, postoperative days 5, 10-12 and 90]