Comparison of the efficacy of TissuePatch™ versus no TissuePatch™ to seal pancreatic tissue surface for the prevention of pancreatic fistula after radical gastrectomy: study protocol for a prospective, single-center, randomized controlled trial.

backgroundPancreatic fistula is a common complication after radical gastrectomy that can be fatal in severe cases. Currently, the avoidance of pressure and thermal injury to the pancreas is the main approach to preventing postoperative pancreatic fistula (POPF); however, its incidence still remains high and seriously affects the perioperative rehabilitation of patients. TissuePatch™ is an absorbable, synthetic, and easy-to-operate patch for sealing, which can effectively prevent liquid leakage on the tissue surface. Therefore, we explored whether TissuePatch™ covering the surface of the pancreas could effectively prevent the occurrence of pancreatic fistula after radical gastrectomy or reduce its severity.

methodsThis is a prospective, single-center, randomized, clinical superiority trial. We will enroll 154 patients who meet the inclusion criteria but do not meet the exclusion criteria for this trial and randomly assign them to an experimental group (77) that uses TissuePatch™ to seal the pancreas surface and to a control group (77) that does not use TissuePatch™. The primary endpoint will be the incidence of POPF about radical gastrectomy. The secondary endpoints will be postoperative mortality, length of postoperative hospital stay, classification of pancreatic fistula, number of lymph node dissections, incidence of postoperative complications, and incidence of TissuePatch™-related complications, such as intestinal adhesion, intestinal obstruction, parenchymal atrophy of the pancreas, chronic pancreatitis, and allergic reactions. DISCUSSION: This trial is the first prospective randomized controlled trial to evaluate whether the use of TissuePatch™ to cover pancreatic capsular wound during radical gastrectomy reduces the incidence of POPF. We speculate that TissuePatch™ will significantly reduce the incidence of POPF and improve the prognosis of patients compared with the non-use group. Moreover, the results of the trial will provide a simple and effective new method for the prevention of pancreatic fistula after radical gastrectomy. ETHICS AND DISSEMINATION: This study was approved by the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20220165) (V2.0). All results of the study will be available and published in peer-reviewed journals.

trial registrationClinicalTrials.gov NCT05404256. Registered on May 20, 2022. STRENGTHS AND LIMITATIONS OF THIS STUDY: This is the first prospective randomized controlled trial to evaluate whether the use of TissuePatch™ to seal the pancreatic tissue surface during radical gastrectomy reduces the incidence of POPF. If TissuePatch™ is shown to significantly reduce the incidence of POPF and improve the perioperative recovery of patients compared to the non-use group, it will be recommended and approved for future radical gastrectomy. Compared to other preventive measures, TissuePatch™ is simple and easy to perform and has a short intraoperative time and learning curve. Since this is a single-center study, the results need to be further validated in a multicenter randomized controlled clinical trial.