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)

Sponsors

Lead Sponsor: University of Toyama

Collaborator: 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

Source University of Toyama
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.

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.

Overall Status Enrolling by invitation
Start Date 2018-10-10
Completion Date 2021-05-01
Primary Completion Date 2021-05-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of a clinically relevant POPF (ISGPS grade B/C) within 3 months after surgery
Secondary Outcome
Measure Time Frame
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
Incidence of intraabdominal abscess within 3 months after surgery
Incidence of postpancreatectomy hemorrhage (PPH) within 3 months after surgery
Incidence of interventional drainage within 3 months after surgery
Incidence of overall postoperative complications within 3 months after surgery
Incidence of POPF-related complications (POPF+DGE+abscess+PPH) within 3 months after surgery
Incidence of 3-month mortality within 3 months after surgery
Incidence of reoperation within 3 months after surgery
Incidence of readmission within 3 months after surgery
Enrollment 514
Condition
Intervention

Intervention Type: Drug

Intervention Name: PGA felt reinforcement

Description: 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.

Arm Group Label: PGA felt reinforcement

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Tsutomu Fujii, MD, PhD Principal Investigator University of Toyama
Location
Facility: University of Toyama
Location Countries

Japan

Verification Date

2020-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Toyama

Investigator Full Name: Tsutomu Fujii

Investigator Title: MD, PhD, FACS

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Control

Type: No Intervention

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

Label: PGA felt reinforcement

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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