A Single-Center, Phase 3, Randomized Controlled Trial of Pancreaticojejunostomy vs Pancreaticogastrostomy with Externalized Stent in High-Risk Pancreatic Anastomosis

Abstract

Background: Patients at high risk for postoperative pancreatic fistula (POPF) still represent a major concern after pancreaticoduodenectomy (PD). While several meta-analyses of randomized controlled trials (RCTs) have supported pancreaticogastrostomy (PG), other trials have highlighted the superiority of pancreaticojejunostomy (PJ) with externalized transanastomotic stents. This RCT compared PJ to PG, both with externalized transanastomotic stents, specifically in the setting of high POPF risk. Methods: Patients undergoing elective PD were prospectively enrolled. The Fistula Risk Score was intraoperatively calculated to identify patients at high risk for POPF that were subsequently randomized according to a 1:1 allocation. The primary endpoint was POPF. The secondary endpoints were Clavien-Dindo ≥ 3 morbidity, postpancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE) and average complication burden (ACB). Findings: The study lasted from July 2017 to March 2019. A total of 604 patients were screened for eligibility, 82 were at high risk for POPF (FRS 7 - 10), and 72 were randomized to PG (n= 36) or PJ (n= 36). There was no significant difference in the incidence of POPF (50.0 vs. 38.9%, p= 0.477) between PG and PJ, but in the patients who developed a POPF, the ACB was lower for PJ (0.39 vs. 0.25, p= 0.039). Additionally, the rates of PPH (38.9 vs 25.0%, p= 0.312) and DGE (44.4 vs. 50.0%, p= 0.814) were similar, but patients who underwent PG presented a significantly higher incidence of Clavien-Dindo ≥ 3 morbidity (47.2 vs. 22.2%, p= 0.047). Interpretation: In patients at the highest risk for POPF, PG and PJ show similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo ≥ 3 morbidity and with an increased ACB in the patients who developed a POPF. Clinical Trial Registration: NCT03212196 (https://www.clinicaltrial.gov). Funding Statement: This study did not receive any financial support. Declaration of Interests: All other authors declare no competing interests. Ethical Approval Statement: The study protocol was approved by the local ethics committee (Ethics Committee of the provinces of Verona and Rovigo, approval number 1041CESC). The trial was performed in accordance with the good clinical practice guidelines, the principles of the Declaration of Helsinki, and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All eligible patients provided written informed consent at the time of hospital admission.