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NCT03331718
PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
Phase 3 trial testing PGA felt reinforcement in Disease of Pancreatic or Periampullary Lesions in 514 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | University of Toyama |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 514 |
| Start date | 10 October 2018 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- PGA felt reinforcement — full drug profile →
Conditions studied
- Disease of Pancreatic or Periampullary Lesions — all drugs for Disease of Pancreatic or Periampullary Lesions →
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):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03331718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03331718 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Toyama
- Last refreshed: 10 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03331718.
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