The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea

Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue, Tsutomu Fujii, Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue, Tsutomu Fujii

Abstract

Background: Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, the technique has not yet been standardized. We devised a new method using double-coated polyglycolic acid felt after pancreaticojejunostomy. The aim of the PLANET-PJ trial is to evaluate the superiority of polyglycolic acid felt reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing partial pancreatoduodenectomy to previous anastomosis methods.

Methods: Patients diagnosed with pancreatic or periampullary lesions in whom it is judged that the main pancreatic duct diameter was 3 mm or less on the left side of the portal vein without pancreatic parenchymal atrophy due to obstructive pancreatitis are considered eligible for inclusion. This study is designed as a multicentre randomized phase III trial in Japan and the Republic of Korea. Eligible patients will be centrally randomized to either group A (polyglycolic acid felt reinforcement) or group B (control). In total, 514 patients will be randomized in 31 high-volume centres in Japan and Republic of Korea. The primary endpoint is the incidence of POPF (International Study Group of Pancreatic Surgery grade B/C).

Discussion: The PLANET-PJ trial evaluates the efficacy of a new method using double-coated polyglycolic acid felt reinforcement for preventing POPF after pancreaticojejunostomy. This new method may reduce POPF.

Trial registration: ClinicalTrials.gov, NCT03331718 . University Hospital Medical Information Network Clinical Trials Registry, UMIN000029647. Registered on 30 November 2017. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874.

Keywords: International multicentre study; Pancreaticojejunostomy; Pancreatoduodenectomy; Polyglycolic acid felt; Postoperative pancreatic fistula.

Conflict of interest statement

The authors declare that they have competing interests with GUNZE LIMITED, Kyoto, Japan, because this study is funded by this company.

Figures

Fig. 1
Fig. 1
Flow diagram of the PLANET-PJ trial. ECOG Eastern Cooperative Oncology Group, PGA polyglycolic acid
Fig. 2
Fig. 2
Method using double-coated polyglycolic acid (PGA) felt during pancreaticojejunostomy. a A 0.3-mm thick PGA felt (Neoveil®; GUNZE, Japan) will be pasted on the ventral side and the dorsal side of the pancreatic parenchyma. b Before abdominal closure, a 0.15-mm thick PGA felt will be further covered around the anastomotic site and fibrin glue will be sprayed
Fig. 3
Fig. 3
Study calendar. CT/MRI computed tomography/magnetic resonance imaging, POD postoperative day

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