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

University of Toyama

Status and phase: Active, not recruiting; Phase 3

Conditions: Disease of Pancreatic or Periampullary Lesions

Treatments: Drug: PGA felt reinforcement

Study type: Interventional

Funder types: Other

Identifiers

NCT03331718

PLANET-PJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 514 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

514 participants in 2 patient groups

Control

No Intervention group

Description:

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

PGA felt reinforcement

Active Comparator group

Description:

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

Treatment:

Drug: PGA felt reinforcement