Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331718
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2017
Last Update Posted : November 4, 2020
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

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • 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)
  • Length of the hospital stay [ Time Frame: within 3 months after surgery ]
    Number of days from operation date to discharge date
  • 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
  • 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)
  • Incidence of delayed gastric emptying (DGE) [ Time Frame: within 3 months after surgery ]
    Incidence of overall DGE, according to the ISGPS criteria
  • 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
  • Incidence of postpancreatectomy hemorrhage (PPH) [ Time Frame: within 3 months after surgery ]
    Incidence of overall PPH, according to the ISGPS criteria
  • Incidence of interventional drainage [ Time Frame: within 3 months after surgery ]
    Incidence of additional drainage percutaneously or endoscopically
  • Incidence of overall postoperative complications [ Time Frame: within 3 months after surgery ]
    Incidence of overall postoperative complications, according to Clavien-Dindo classification
  • 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
  • Incidence of 3-month mortality [ Time Frame: within 3 months after surgery ]
    Incidence of surgery-related deaths from operation date to postoperative 3 months
  • Incidence of reoperation [ Time Frame: within 3 months after surgery ]
    Incidence of reoperation from operation date to postoperative 3 months
  • Incidence of readmission [ Time Frame: within 3 months after surgery ]
    Incidence of readmission from operation date to postoperative 3 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
Official Title  ICMJE PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Disease of Pancreatic or Periampullary Lesions
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: PGA felt reinforcement
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
514
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
550
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331718
Other Study ID Numbers  ICMJE PLANET-PJ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tsutomu Fujii, University of Toyama
Study Sponsor  ICMJE University of Toyama
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Tsutomu Fujii, MD, PhD University of Toyama
PRS Account University of Toyama
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP