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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

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Authors
Shibuya, Kazuto; Jang, Jin-Young; Satoi, Sohei; Sho, Masayuki; Yamada, Suguru; Kawai, Manabu; Kim, Hongbeom; Kim, Song Cheol; Heo, Jin Seok; Yoon, Yoo-Seok; Park, Joon Seong; Hwang, Ho Kyoung; Yoshioka, Isaku; Shimokawa, Toshio; Yamaue, Hiroki; Fujii, Tsutomu
Issue Date
2019-08-09
Publisher
BioMed Central
Citation
Trials, 20(1):490
Keywords
PancreatoduodenectomyPancreaticojejunostomyPostoperative pancreatic fistulaPolyglycolic acid feltInternational multicentre study
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
ISSN
1745-6215
Language
English
URI
http://hdl.handle.net/10371/162604
DOI
https://doi.org/10.1186/s13063-019-3595-x
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College of Medicine/School of Medicine (의과대학/대학원)Surgery (외과학전공)Journal Papers (저널논문_외과학전공)
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