| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Effect of Double Layer Polyglycolic Acid Felt for Reducing Pancreatic Fistula After Pancreatoduodenectomy: Results of a Multicenter Randomized Control Trial (PLANET-PJ trial). |
| 掲載誌名 | 正式名：Annals of surgery 略 称：Ann Surg ISSNコード：15281140/00034932 |
| 掲載区分 | 国外 |
| 巻・号・頁 | pp.Online ahead of print |
| 著者・共著者 | Kazuto Shibuya, Joon Seong Park, Wooil Kwon, Manabu Kawai, Isaku Yoshioka, Daisuke Hashimoto, Hideki Takami, Chang-Sup Lim, Hyung Il Seo, Minako Nagai, Yosuke Inoue, Yoo-Seok Yoon, Seung Eun Lee, Hideo Baba, Sae Byeol Choi, Hyeon Kook Lee, Jae Do Yang, Yasutoshi Kimura, Ho Kyoung Hwang, Yang Won Nah, Masaji Tani, Keiichi Akahoshi, In Woong Han, Yuichi Nagakawa, Hidetoshi Eguchi, Suguru Yamada, Sohei Satoi, Masayuki Sho, Megumi Kitayama, Ke Wan, Toshio Shimokawa, Hiroki Yamaue, Jin-Young Jang, Tsutomu Fujii |
| 発行年月 | 2025/07 |
| 概要 | 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.SUMMARY BACKGROUND DATA: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 less than 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 were also not significantly different between the two 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. |
| DOI | 10.1097/SLA.0000000000006857 |
| PMID | 40728222 |