Efficacy of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for benign or low-grade malignant pancreatic tumors: study protocol for a randomized controlled trial

Abstract BackgroundBased on previous meta-analyses and comparative evidence, robotic approach might lead to a higher or at least similar spleen-preservation rates when comparing with laparoscopic approach in spleen preserving distal pancreatectomy (SPDP) for benign or low-grade malignant pancreatic tumors1–3. But high-quality evidence lacks and controversy exists. Therefore, we planned to initiate a prospective, patient-blinded, randomized, controlled trial (RCT) to compare robotic assisted spleen preserving distal pancreatectomy (RSPDP) with laparoscopic spleen preserving distal pancreatectomy (LSPDP), with special consideration to the success rate of splenic vessel-preserving (Kimura) approach, as well as perioperative variables, and cost analysis.MethodsPatients with benign or low-grade malignant pancreatic tumors are potential candidates for this RCT. Enrolled participants are randomized into RSPDP (observational arm) or LSPDP (control arm) groups as a ratio of 1:1. The primary outcome is the success rate of splenic vessel-preserving (Kimura) approach. The secondary outcomes include total success rate of spleen preserving (Kimura and Warshaw approaches), intraoperative variables, time to functional recovery, postoperative complications, mortality, and cost/efficacy analysis.DiscussionWe plan to conduct a randomized controlled trial to detect the potential advantages of robotic approach in spleen vessels preservation compared with traditional laparoscopic approach. RSPDP may improve spleen vessels preservation rate in selected patients.Trial registrationChinese Clinical Trial Registry, No: ChiCTR2000029177. Registered on 18 January, 2020.