Annals of surgery · 2025
Effect of Double Layer Polyglycolic Acid Felt for Reducing Pancreatic Fistula After Pancreatoduodenectomy: Results of a Multicenter Randomized Control Trial (PLANET-PJ trial).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Shibuya Kazuto, Park Joon Seong, Kwon Wooil, Kawai Manabu, Yoshioka Isaku, Hashimoto Daisuke, Takami Hideki, Lim Chang-Sup, Seo Hyung Il, Nagai Minako, Inoue Yosuke, Yoon Yoo-Seok, Lee Seung Eun, Baba Hideo, Choi Sae Byeol, Lee Hyeon Kook, Do Yang Jae, Kimura Yasutoshi, Hwang Ho Kyoung, Nah Yang Won, Tani Masaji, Akahoshi Keiichi, Han In Woong, Nagakawa Yuichi, Eguchi Hidetoshi, Yamada Suguru, Satoi Sohei, Sho Masayuki, Kitayama Megumi, Wan Ke, Shimokawa Toshio, Yamaue Hiroki, Jang Jin-Young, Fujii Tsutomu
Аннотация
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.
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.