Laparoscopic versus open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic ductal adenocarcinoma: protocol of a multicenter, open-label randomized clinical trial (CSPAC-5)

Abstract Background Surgery remains the only effective potential curative method for pancreatic ductal adenocarcinoma (PDAC). For borderline resectable PDAC, neoadjuvant chemotherapy (NACT) can reduce tumor volume, decrease the rate of pathologic lymph nodes, increase the R0 resection rate, and improve disease-free survival and overall survival. Although the feasibility and safety of laparoscopic pancreatoduodenectomy (LPD) has been established by several randomized controlled trials, there are few reports about the outcomes of LPD versus open pancreatoduodenectomy (OPD) among borderline resectable PDAC patients after NACT. Further studies are necessary to compare the safety and efficacy of these two surgical techniques following NACT. Methods CSPAC-5 is a prospective, multicenter, randomized, parallel-controlled clinical trial. Patients pathologically diagnosed as PDAC receive at least two cycles of NACT after a multidisciplinary assessment. The National Comprehensive Cancer Network guideline resectable status and the response evaluation criteria in solid tumors (RECIST, version 1.1) are used to evaluate tumor response to NACT. Approximately 120 borderline resectable pancreatic cancer patients will be randomized to receive LPD or OPD in a 1:1 ratio. The primary outcome is the postoperative complication rate. The trial registration date is March 15, 2021. The study was launched in April 2021 and is expected to complete recruitment within five years, with an estimated completion date of December 2025. Discussion CSPAC-5 is a national multicenter randomized controlled trial designed to compare the safety and efficacy of LPD and OPD among patients with borderline resectable PDAC following NACT. The trial results will provide high-level evidence-based guidelines on surgical options for borderline resectable PDAC patients after NACT. Trial registration ClinicalTrials.gov Identifier: NCT04855331. Registered 22 April 2021, https://www.clinicaltrials.gov/ct2/show/NCT04855331.