Splenic-preserving laparoscopic distal pancreatectomy Kimura technique versus Warshaw technique: study protocol for a single-center, patient-blinded, randomized controlled clinical trial

Background: Laparoscopic spleen-preserving distal pancreatectomy (LSPDP) has widely been used to manage benign and low-grade malignant tumors of the body and tail of the pancreas. Two commonly employed procedures are the Kimura and Warshaw techniques. However, the comparative benefits of these techniques for patient outcomes remain unclear. Consequently, we have undertaken a randomized controlled clinical trial to comprehensively compare the advantages and disadvantages of the laparoscopic Kimura and Warshaw techniques, and here we present the protocol of this clinical trial. Methods: This trial is a single-center, parallel-group, patient-blinded, randomized controlled clinical trial. Patients diagnosed with benign or low-grade malignant tumors of the body and tail of the pancreas are recruited. Patients in the test group underwent the laparoscopic Kimura technique, while patients in the control group underwent the laparoscopic Warshaw technique. The primary outcome for short- and long-term follow-up are intraoperative blood loss, and perigastric varices, respectively. Secondary outcomes include spleen preservation, conversion, postoperative mortality, pancreatic fistula, delayed gastric emptying, abdominal infection, reoperation, and splenic infarction. Conclusion: A prospective interventional clinical randomized controlled trial (RCT) is expected to elucidate the benefits and drawbacks of the laparoscopic Kimura technique compared to the Warshaw technique for managing benign and low-grade malignant tumors of the body and tail of the pancreas. Trial registration: ChiCTR2200057763