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

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ClinicalTrials.gov Identifier: NCT03331718
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Tsutomu Fujii, 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.

Condition or disease Intervention/treatment Phase
Disease of Pancreatic or Periampullary Lesions Drug: PGA felt reinforcement Phase 3

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  (Clinical Trial)
Estimated Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

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.




Primary Outcome Measures :
  1. Incidence of a clinically relevant POPF (ISGPS grade B/C) [ Time Frame: within 3 months after surgery ]
    Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF


Secondary Outcome Measures :
  1. Length of drain placement [ Time Frame: within 3 months after surgery ]
    Number of days from operation date to drain removal date (the peripancreatic drain to be removed last)

  2. Length of the hospital stay [ Time Frame: within 3 months after surgery ]
    Number of days from operation date to discharge date

  3. Incidence of overall POPF (Biochemical leak, grade B, and C) [ Time Frame: within 3 months after surgery ]
    Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria

  4. Incidence of POPF by each suturing method to approximate the pancreas and the jejunum [ Time Frame: within 3 months after surgery ]
    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)

  5. Incidence of delayed gastric emptying (DGE) [ Time Frame: within 3 months after surgery ]
    Incidence of overall DGE, according to the ISGPS criteria

  6. Incidence of intraabdominal abscess [ Time Frame: within 3 months after surgery ]
    Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification

  7. Incidence of postpancreatectomy hemorrhage (PPH) [ Time Frame: within 3 months after surgery ]
    Incidence of overall PPH, according to the ISGPS criteria

  8. Incidence of interventional drainage [ Time Frame: within 3 months after surgery ]
    Incidence of additional drainage percutaneously or endoscopically

  9. Incidence of overall postoperative complications [ Time Frame: within 3 months after surgery ]
    Incidence of overall postoperative complications, according to Clavien-Dindo classification

  10. Incidence of POPF-related complications (POPF+DGE+abscess+PPH) [ Time Frame: within 3 months after surgery ]
    Incidence of cases in whom one of 3), 5), 6) or 7) occurred

  11. Incidence of 3-month mortality [ Time Frame: within 3 months after surgery ]
    Incidence of surgery-related deaths from operation date to postoperative 3 months

  12. Incidence of reoperation [ Time Frame: within 3 months after surgery ]
    Incidence of reoperation from operation date to postoperative 3 months

  13. Incidence of readmission [ Time Frame: within 3 months after surgery ]
    Incidence of readmission from operation date to postoperative 3 months



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331718


Contacts
Contact: Tsutomu Fujii, MD, PhD +81764347331 fjt@med.u-toyama.ac.jp

Locations
Japan
University of Toyama Not yet recruiting
Toyama, Japan, 9300194
Contact: Tsutomu Fujii, MD, PhD    +81-764347331    fjt@med.u-toyama.ac.jp   
Sponsors and Collaborators
University of Toyama
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
Investigators
Principal Investigator: Tsutomu Fujii, MD, PhD University of Toyama

Responsible Party: Tsutomu Fujii, MD, PhD, FACS, University of Toyama
ClinicalTrials.gov Identifier: NCT03331718     History of Changes
Other Study ID Numbers: PLANET-PJ
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsutomu Fujii, University of Toyama:
pancreatoduodenectomy
pancreaticojejunostomy
polyglycolic acid
Neoveil
pancreatic fistula
pancreas