Effect of Double Layer Polyglycolic Acid Felt for Reducing Pancreatic Fistula After Pancreatoduodenectomy Results of a Multicenter Randomized Control Trial (PLANET-PJ trial)

Abstract

Objective: To evaluate the usefulness of a double coating of polyglycolic acid (PGA) felt for pancreaticojejunostomy in reducing the incidence of clinically relevant postoperative pancreatic fistula (POPF) in patients with a normal pancreas. Background: Despite pancreaticojejunostomy being an advanced procedure in patients undergoing pancreatoduodenectomy (PD), few studies have reported a satisfactory reduction in the incidence of POPF. Methods: This study was an international multicenter randomized controlled trial conducted between October 2018 and December 2021. Patients with a main pancreatic duct <3 mm in diameter and soft pancreas undergoing pancreaticojejunostomy were eligible and randomized to either Arm A (conventional pancreaticojejunostomy) or Arm B (pancreaticojejunostomy using double coating of PGA felt). The primary endpoint was the incidence of grade B/C POPF. This trial was registered at ClinicalTrials.gov (NCT03331718) and Japan Registry of Clinical Trials (jRCTs042180090). Results: A total of 514 patients were enrolled and randomly assigned to the study. The full analysis set population consisted of 508 patients, including 253 patients in Arm A and 255 patients in Arm B. According to the full analysis, the incidence of grade B/C POPF in Arm A was 28%, whereas that in Arm B was 25% (adjusted odds ratio: 0.97, 95% CI: 0.90-1.05; P=0.453). The incidence of intra-abdominal abscesses and mortality was also not significantly different between the 2 groups. Conclusions: This study showed that the use of a double coating of PGA felt in patients undergoing pancreaticojejunostomy did not reduce the incidence of grade B/C POPF.