Disease of Pancreatic or Periampullary LesionsPhase 3NCT03331718
PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
A Phase 3 study testing PGA felt reinforcement in people with Disease of Pancreatic or Periampullary Lesions, run by University of Toyama at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Disease of Pancreatic or Periampullary Lesions
- What is being tested?
- PGA felt reinforcement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteJapan
- Study dates
- 10 Oct 2018to 31 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Contrast media allergy of both iodine and gadolinium
- Active duplicate cancer thought to affect adverse events
- Severe psychological or neurological disease
- Drug abuse or alcoholics
- Planned use of octreotide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
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.
Read the detailed description
Pancreatojejunostomy is generally a combination of suture between the pancreatic parenchyma and the seromuscular layer of the jejunum, and duct-to-mucosa suture. The clinical study about the various kinds of pancreatojejunostomy have been reported for the purpose of lowering the frequency of POPF; however, the frequency of more than grade B POPF is still around 10 to 20%. In soft pancreas cases with unexpanded pancreatic ducts, the risk is further elevated.
The polyglycolic acid (PGA) felt is an absorbable suture reinforcing material. It is generally used to reinforce sutures of fragile tissues such as the lung, bronchi, liver, and gastrointestinal tract, and to reinforce a wide range of tissue defects. Regarding pancreatojejunostomy using a PGA felt, the incidence of POPF formation was decreased in some retrospective studies; on the other hand, no significant difference was found in other study. As described above, 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.
- Being tested
- PGA felt reinforcement
- Keywords
- pancreatoduodenectomy, pancreaticojejunostomy, polyglycolic acid, Neoveil, pancreatic fistula, pancreas
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGA felt reinforcementDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PGA felt reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3 months after surgery
Secondary outcomes (13)
Length of drain placement
Number of days from operation date to drain removal date (the peripancreatic drain to be removed last)
Measured: within 3 months after surgery
Length of the hospital stay
Number of days from operation date to discharge date
Measured: within 3 months after surgery
Incidence of overall POPF (Biochemical leak, grade B, and C)
Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria
Measured: within 3 months after surgery
Incidence of POPF by each suturing method to approximate the pancreas and the jejunum
Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria by each suturing method to approximate the pancreas and the jejunum (Kakita, two-layer, or Blumgart)
Measured: within 3 months after surgery
Incidence of delayed gastric emptying (DGE)
Incidence of overall DGE, according to the ISGPS criteria
Measured: within 3 months after surgery
Incidence of intraabdominal abscess
Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification
Measured: within 3 months after surgery
Incidence of postpancreatectomy hemorrhage (PPH)
Incidence of overall PPH, according to the ISGPS criteria
Measured: within 3 months after surgery
Incidence of interventional drainage
Incidence of additional drainage percutaneously or endoscopically
Measured: within 3 months after surgery
Incidence of overall postoperative complications
Incidence of overall postoperative complications, according to Clavien-Dindo classification
Measured: within 3 months after surgery
Incidence of POPF-related complications (POPF+DGE+abscess+PPH)
Incidence of cases in whom one of 3), 5), 6) or 7) occurred
Measured: within 3 months after surgery
Incidence of 3-month mortality
Incidence of surgery-related deaths from operation date to postoperative 3 months
Measured: within 3 months after surgery
Incidence of reoperation
Incidence of reoperation from operation date to postoperative 3 months
Measured: within 3 months after surgery
Incidence of readmission
Incidence of readmission from operation date to postoperative 3 months
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Oct 2018
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disease of Pancreatic or Periampullary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toyama
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Kansai Medical University, Kumamoto University, Nagoya University, Nara Medical University, Osaka City University, Osaka University, Shiga Medical University, Shimane University, Tokyo Medical and Dental University, Tokyo Medical University, Wakayama Medical University, Gangnam Severance Hospital, National Cancer Center, Korea, Samsung Medical Center, Seoul National University Bundang Hospital, Severance Hospital
- Responsible party
- Principal investigator, Tsutomu Fujii, University of Toyama
- Investigators
- Tsutomu Fujii, MD, PhD, Principal investigator, University of Toyama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331718
- Sponsor's protocol ID
- PLANET-PJ
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2017
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40728222Shibuya 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.
PubMed 31399139
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
- ClinicalTrials.gov ID
- NCT03331718
- Acronym / sponsor ID
- PLANET-PJ
- Keywords
- pancreatoduodenectomy, pancreaticojejunostomy, polyglycolic acid, Neoveil, pancreatic fistula, pancreas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- University of ToyamaUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Kansai Medical University, Kumamoto University, Nagoya University, Nara Medical University, Osaka City University, Osaka University, Shiga Medical University, Shimane University, Tokyo Medical and Dental University, Tokyo Medical University, Wakayama Medical University, Gangnam Severance Hospital, National Cancer Center, Korea, Samsung Medical Center, Seoul National University Bundang Hospital, Severance Hospital
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatojejunostomy is generally a combination of suture between the pancreatic parenchyma and the seromuscular layer of the jejunum, and duct-to-mucosa suture. The clinical study about the various kinds of pancreatojejunostomy have been reported for the purpose of lowering the frequency of POPF; however, the frequency of more than grade B POPF is still around 10 to 20%. In soft pancreas cases with unexpanded pancreatic ducts, the risk is further elevated.
The polyglycolic acid (PGA) felt is an absorbable suture reinforcing material. It is generally used to reinforce sutures of fragile tissues such as the lung, bronchi, liver, and gastrointestinal tract, and to reinforce a wide range of tissue defects. Regarding pancreatojejunostomy using a PGA felt, the incidence of POPF formation was decreased in some retrospective studies; on the other hand, no significant difference was found in other study. As described above, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual. |
| PGA felt reinforcement | Active comparator | Drug: PGA felt reinforcementIn addition to usual pancreaticojejunostomy, PGA felt is used in duplicate. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PGA felt reinforcementDuring 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. | Drug | PGA felt reinforcement |
Primary outcome
Incidence of a clinically relevant POPF (ISGPS grade B/C)
Time frame: within 3 months after surgery
Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF
13 secondary outcomes
Length of drain placement
Time frame: within 3 months after surgery
Length of the hospital stay
Time frame: within 3 months after surgery
Incidence of overall POPF (Biochemical leak, grade B, and C)
Time frame: within 3 months after surgery
Incidence of POPF by each suturing method to approximate the pancreas and the jejunum
Time frame: within 3 months after surgery
Incidence of delayed gastric emptying (DGE)
Time frame: within 3 months after surgery
Incidence of intraabdominal abscess
Time frame: within 3 months after surgery
Incidence of postpancreatectomy hemorrhage (PPH)
Time frame: within 3 months after surgery
Incidence of interventional drainage
Time frame: within 3 months after surgery
Incidence of overall postoperative complications
Time frame: within 3 months after surgery
Incidence of POPF-related complications (POPF+DGE+abscess+PPH)
Time frame: within 3 months after surgery
Incidence of 3-month mortality
Time frame: within 3 months after surgery
Incidence of reoperation
Time frame: within 3 months after surgery
Incidence of readmission
Time frame: within 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40728222Shibuya 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.
- Derived from this study: PubMed 31399139Shibuya 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsutomu Fujii, MD, PhD principal investigator
University of Toyama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PGA felt reinforcement in people with Disease of Pancreatic or Periampullary Lesions, run by University of Toyama at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a clinically relevant POPF (ISGPS grade B/C) (time frame: within 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.