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

NCT03331718 | Completed Phase 3

• 1 other identifier: PLANET-PJ
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pancreatoduodenectomy; pancreaticojejunostomy; polyglycolic acid; Neoveil; pancreatic fistula; pancreas

Outcome Measures

Primary Outcomes (1)

• Incidence of a clinically relevant POPF (ISGPS grade B/C)

  Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF

  within 3 months after surgery

Secondary Outcomes (13)

• Length of drain placement

  within 3 months after surgery

• Length of the hospital stay

  within 3 months after surgery

• Incidence of overall POPF (Biochemical leak, grade B, and C)

  within 3 months after surgery

• Incidence of POPF by each suturing method to approximate the pancreas and the jejunum

  within 3 months after surgery

• Incidence of delayed gastric emptying (DGE)

  within 3 months after surgery

Study Arms (2)

Control

NO INTERVENTION

Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual.

PGA felt reinforcement

ACTIVE COMPARATOR

In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.

Drug: PGA felt reinforcement

Interventions

PGA felt reinforcement DRUG

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.

PGA felt reinforcement

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
• Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
• MPD diameter ≤3mm on the left side of the portal vein in preoperative imaging (CT or MRI)
• Performance status (ECOG scale): 0-1 at the time of enrollment
• Age: 20 years or older
• Adequate organ function A) Leukocyte count: ≥2500 mm3, ≤14000 mm3 B) Hemoglobin: ≥9.0 g/dL C) Platelet count: ≥100,000 mm3 D) Total Bilirubin: ≤2.0 mg/dL (not apply to cases with obstructive jaundice) E) Creatinine: ≤2.0 mg/dL
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Planned pancreatogastrostomy
• Laparoscopic or laparoscope-assisted pancreatoduodenectomy
• Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis
• Neoadjuvant treatment including chemotherapy or radiotherapy
• History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy
• Emergency operation
• Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery
• Severe ischemic heart disease
• Severe liver dysfunction due to liver cirrhosis or active hepatitis
• Severe respiratory disorder required oxygen inhalation
• Chronic renal failure with dialysis
• Requiring resection of other organs (liver or colon) during pancreatoduodenectomy
• Immunosuppressive treatment
• History of severe hypersensitivity to PGA felt and fibrin glue
• Other severe drug allergies

Sponsors & Collaborators

• Kansai Medical University: collaborator
• Kumamoto University: collaborator
• Nagoya University: collaborator
• Nara Medical University: collaborator
• Osaka City University: collaborator
• Osaka University: collaborator
• Shiga Medical University: collaborator
• Shimane University: collaborator
• Tokyo Medical and Dental University: collaborator
• Tokyo Medical University: collaborator
• Wakayama Medical University: collaborator
• Gangnam Severance Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Samsung Medical Center: collaborator
• University of Toyama: lead
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

University of Toyama

Toyama, Toyama, 9300194, Japan

Location

Related Publications (2)

• Shibuya K, Park JS, Kwon W, Kawai M, Yoshioka I, Hashimoto D, Takami H, Lim CS, Seo HI, Nagai M, Inoue Y, Yoon YS, Lee SE, Baba H, Choi SB, Lee HK, Do Yang J, Kimura Y, Hwang HK, Nah YW, Tani M, Akahoshi K, Han IW, Nagakawa Y, Eguchi H, Yamada S, Satoi S, Sho M, Kitayama M, Wan K, Shimokawa T, Yamaue H, Jang JY, Fujii T. Effect of Double Layer Polyglycolic Acid Felt for Reducing Pancreatic Fistula After Pancreatoduodenectomy: Results of a Multicenter Randomized Control Trial (PLANET-PJ trial). Ann Surg. 2026 Mar 1;283(3):398-409. doi: 10.1097/SLA.0000000000006857. Epub 2025 Jul 29.

  PMID: 40728222 DERIVED

• Shibuya K, Jang JY, Satoi S, Sho M, Yamada S, Kawai M, Kim H, Kim SC, Heo JS, Yoon YS, Park JS, Hwang HK, Yoshioka I, Shimokawa T, Yamaue H, Fujii T. 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. Trials. 2019 Aug 9;20(1):490. doi: 10.1186/s13063-019-3595-x.

  PMID: 31399139 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tsutomu Fujii, MD, PhD

  University of Toyama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FACS

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 6, 2017
• Study Start: October 10, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)