Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China.

Pancreaticoduodenectomy (PD) is the preferred surgical approach for resectable periampullary carcinomas. Non-pancreatic periampullary carcinomas (NPPC) demonstrate distinct biological behaviours and are generally less aggressive than pancreatic cancer. Despite over three decades of advancements, the role of laparoscopic PD (LPD) remains debated. Few studies have directly compared LPD and open PD (OPD) while accounting for tumour invasiveness, and the data specifically evaluating LPD vs OPD for NPPC are limited. Randomised controlled trials are necessary to determine whether therapeutic outcomes differ between LPD and OPD in NPPC patients. The TJDBPS14 trial is a prospective, randomised controlled, open-label, multicentre non-inferiority study with a parallel-group design. All participating surgeons have performed at least 104 LPD and OPD procedures. A total of 212 selected patients diagnosed with NPPC and eligible for PD will be randomly assigned to either LPD or OPD. The primary outcome is postoperative hospital stay, with secondary outcomes including 1-year survival rate, perioperative outcomes, incidence of perioperative complications, short-term outcomes and quality of life. The hypothesis is that the postoperative hospital stay for the LPD group will not exceed that of the OPD group. This study was approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, with independent third-party monitoring. The results of the trial will be presented at international conferences and published in peer-reviewed journals. NCT05788029. Registered on 30 November 2022.