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NCT03331718

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

Status unknown Phase 3 Last updated 10 May 2023
What this trial tests

Phase 3 trial testing PGA felt reinforcement in Disease of Pancreatic or Periampullary Lesions in 514 participants. Status unknown.

Timeline
10 October 2018
Primary endpoint
31 December 2021
31 December 2024

Quick facts

Lead sponsorUniversity of Toyama
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment514
Start date10 October 2018
Primary completion31 December 2021
Estimated completion31 December 2024
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

University of Toyama

Who can join

20 and older, any sex, with Disease of Pancreatic or Periampullary Lesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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 f
    Shibuya K, Jang JY, Satoi S, Sho M, et al · · 2019 · cited 7× · PMID 31399139 · DOI 10.1186/s13063-019-3595-x
  2. Effect of artificial or autologous coverage of the pancreatic remnant or anastomosis on postoperative pancreatic fistulas after partial pancreatectomy: meta-analysis of randomized clinical trials.
    Walber JK, Antony P, Strothmann H, Kalkum E, et al · · 2024 · cited 2× · PMID 38814751 · DOI 10.1093/bjsopen/zrae059
  3. Effect of Double Layer Polyglycolic Acid Felt for Reducing Pancreatic Fistula After Pancreatoduodenectomy: Results of a Multicenter Randomized Control Trial (PLANET-PJ trial).
    Shibuya K, Park JS, Kwon W, Kawai M, et al · · 2026 · PMID 40728222 · DOI 10.1097/sla.0000000000006857

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