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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Disease of Pancreatic or Periampullary Lesions
• Intervention / Treatment: Drug: PGA felt reinforcement

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 Type: Interventional
• Enrollment (Anticipated): 514
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Toyama, Japan, 9300194
    • University of Toyama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
2. Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
3. MPD diameter ≤3mm on the left side of the portal vein in preoperative imaging (CT or MRI)
4. Performance status (ECOG scale): 0-1 at the time of enrollment
5. Age: 20 years or older
6. 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
7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Planned pancreatogastrostomy
2. Laparoscopic or laparoscope-assisted pancreatoduodenectomy
3. Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis
4. Neoadjuvant treatment including chemotherapy or radiotherapy
5. History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy
6. Emergency operation
7. Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery
8. Severe ischemic heart disease
9. Severe liver dysfunction due to liver cirrhosis or active hepatitis
10. Severe respiratory disorder required oxygen inhalation
11. Chronic renal failure with dialysis
12. Requiring resection of other organs (liver or colon) during pancreatoduodenectomy
13. Immunosuppressive treatment
14. History of severe hypersensitivity to PGA felt and fibrin glue
15. Other severe drug allergies
16. Contrast media allergy of both iodine and gadolinium
17. Active duplicate cancer thought to affect adverse events
18. Severe psychological or neurological disease
19. Drug abuse or alcoholics
20. Planned use of octreotide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual.
Active Comparator: PGA felt reinforcement; In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of drain placement	Number of days from operation date to drain removal date (the peripancreatic drain to be removed last)	within 3 months after surgery
Length of the hospital stay	Number of days from operation date to discharge date	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	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)	within 3 months after surgery
Incidence of delayed gastric emptying (DGE)	Incidence of overall DGE, according to the ISGPS criteria	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	within 3 months after surgery
Incidence of postpancreatectomy hemorrhage (PPH)	Incidence of overall PPH, according to the ISGPS criteria	within 3 months after surgery
Incidence of interventional drainage	Incidence of additional drainage percutaneously or endoscopically	within 3 months after surgery
Incidence of overall postoperative complications	Incidence of overall postoperative complications, according to Clavien-Dindo classification	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	within 3 months after surgery
Incidence of 3-month mortality	Incidence of surgery-related deaths from operation date to postoperative 3 months	within 3 months after surgery
Incidence of reoperation	Incidence of reoperation from operation date to postoperative 3 months	within 3 months after surgery
Incidence of readmission	Incidence of readmission from operation date to postoperative 3 months	within 3 months after surgery

Collaborators and Investigators

• Sponsor: University of Toyama
• Collaborators: National Cancer Center, Korea; Samsung Medical Center; Seoul National University Hospital; Seoul National University Bundang Hospital; Osaka University; Gangnam Severance Hospital; Severance Hospital; Kumamoto University; Nagoya University; Wakayama Medical University; Tokyo Medical and Dental University; Osaka City University; Tokyo Medical University; Nara Medical University; Kansai Medical University; Shiga Medical University; Shimane University
• Investigators: Principal Investigator: Tsutomu Fujii, MD, PhD, University of Toyama

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pancreas; pancreatic fistula; pancreaticojejunostomy; pancreatoduodenectomy; Neoveil; polyglycolic acid
• Other Study ID Numbers: PLANET-PJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No