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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029647
Receipt No. R000033874
Scientific Title Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial-
Date of disclosure of the study information 2017/11/30
Last modified on 2018/10/26

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Basic information
Public title Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial-
Acronym Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial-
Scientific Title Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial-
Scientific Title:Acronym Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial-
Region
Japan Asia(except Japan)

Condition
Condition Patients who are scheduled to undergo pancreatoduodenectomy for disease of pancreatic or periampullary lesions
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to evaluate the efficacy of PGA mesh reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing pancreatoduodenectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of a clinically relevant POPF grade B or C by the International Study Group of Pancreatic Surgery (ISGPS) criteria
Key secondary outcomes Length of the drain placement
Length of the hospital stay
Incidence of overall POPF (Biochemical leak, grade B, and C)
Incidence of POPF by each suturing method to approximate the pancreas and the jejunum
Incidence of delayed gastric emptying (DGE)
Incidence of intraabdominal abscess
Incidence of postpancreatectomy hemorrhage (PPH)
Incidence of interventional drainage
Incidence of overall postoperative complications
Incidence of POPF-related complications (POPF+DGE+abscess+PPH)
Incidence of 3-month mortality
Incidence of reoperation
Incidence of readmission

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Interventional group: PGA mesh reinforcement in pancreaticojejunostomy in patients undergoing pancreatoduodenectomy
Interventions/Control_2 Control group: pancreaticojejunostomy in patients undergoing pancreatoduodenectomy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key 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
Key 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 mesh 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
Target sample size 514

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Fujii
Organization Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name Department of Surgery and Science
Zip code
Address 2630, Sugitani, Toyama
TEL 076-434-7331
Email fjt@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isaku Yoshioka
Organization Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name Department of Surgery and Science
Zip code
Address 2630, Sugitani, Toyama
TEL 076-434-7331
Homepage URL
Email isaku@med.u-toyama.ac.jp

Sponsor
Institute Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Institute
Department

Funding Source
Organization Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka Medical University, Osaka University, Kansai Medical University, Kumamoto University, Shiga Medical University, Shimane University, Tokyo Medical University, Tokyo Medical and Dental University, Nara Medical University, Nagoya University, Wakayama Medical University, Seoul National University Hospital, Gangnam Severance Hospital, Yonsei University College of Medicine, National Cancer Center, Samsung Medical Center, Seoul National University Bundang Hospital, Severance Hospital, Yonsei University College of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 21 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033874

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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