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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disease of Pancreatic or Periampullary Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

PGA felt reinforcement

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

Group Type ACTIVE_COMPARATOR

PGA felt reinforcement

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No