Clinical trial NCT03331718: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
Official title: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Disease of Pancreatic or Periampullary Lesions
Keywords: pancreatoduodenectomy
pancreaticojejunostomy
polyglycolic acid
Neoveil
pancreatic fistula
pancreas
Lead sponsor: University of Toyama
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Kansai Medical University
name: Kumamoto University
name: Nagoya University
name: Nara Medical University
name: Osaka City University
name: Osaka University
name: Shiga Medical University
name: Shimane University
name: Tokyo Medical and Dental University
name: Tokyo Medical University
name: Wakayama Medical University
name: Gangnam Severance Hospital
name: National Cancer Center, Korea
name: Samsung Medical Center
name: Seoul National University Bundang Hospital
name: Severance Hospital
First posted: 2017-11-06
Enrollment: 514
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of a clinically relevant POPF (ISGPS grade B/C)
timeFrame: within 3 months after surgery
Secondary outcomes:
measure: Length of drain placement
timeFrame: within 3 months after surgery
measure: Length of the hospital stay
timeFrame: within 3 months after surgery
measure: Incidence of overall POPF (Biochemical leak, grade B, and C)
timeFrame: within 3 months after surgery
measure: Incidence of POPF by each suturing method to approximate the pancreas and the jejunum
timeFrame: within 3 months after surgery
measure: Incidence of delayed gastric emptying (DGE)
timeFrame: within 3 months after surgery
measure: Incidence of intraabdominal abscess
timeFrame: within 3 months after surgery
measure: Incidence of postpancreatectomy hemorrhage (PPH)
timeFrame: within 3 months after surgery
measure: Incidence of interventional drainage
timeFrame: within 3 months after surgery
measure: Incidence of overall postoperative complications
timeFrame: within 3 months after surgery
measure: Incidence of POPF-related complications (POPF+DGE+abscess+PPH)
timeFrame: within 3 months after surgery
measure: Incidence of 3-month mortality
timeFrame: within 3 months after surgery
measure: Incidence of reoperation
timeFrame: within 3 months after surgery
measure: Incidence of readmission
timeFrame: within 3 months after surgery
Other outcomes:
Locations:
city: Toyama
country: Japan
facility: University of Toyama
Study officials:
affiliation: University of Toyama
name: Tsutomu Fujii, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.