PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)

Summary

The polyglycolic acid (PGA) felt is a felt-like absorbable suture reinforcing material. The pancreatojejunostomy aimed at reducing POPF is not established at present. We devised a new method using doubly PGA felt. This study is a multicenter, randomized phase III trial between Japan and Korea to verify the usefulness of this double coating of PGA felt.

Conditions

• Disease of Pancreatic or Periampullary Lesions

Interventions

DRUG

PGA felt reinforcement

During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil®, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.

Sponsors & Collaborators

• Seoul National University Hospital

  collaborator OTHER

• Kansai Medical University

  collaborator OTHER

• Kumamoto University

  collaborator OTHER

• Nagoya University

  collaborator OTHER

• Nara Medical University

  collaborator OTHER

• Osaka City University

  collaborator OTHER

• Osaka University

  collaborator OTHER

• Shiga Medical University

  collaborator UNKNOWN

• Shimane University

  collaborator UNKNOWN

• Tokyo Medical and Dental University

  collaborator OTHER

• Tokyo Medical University

  collaborator OTHER

• Wakayama Medical University

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• University of Toyama

  lead OTHER

Principal Investigators

• Tsutomu Fujii, MD, PhD · University of Toyama

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-10

Primary Completion

2021-12-31

Completion

2022-01-31

Countries

• Japan

Study Locations