UMIN-CTR Clinical Trial

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 Tsutomu Middle name Last name Fujii
Organization	Faculty of Medicine, Academic Assembly, University of Toyama
Division name	Department of Surgery and Science
Zip code	9300194
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Email	fjt@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Isaku Middle name Last name Yoshioka
Organization	Faculty of Medicine, Academic Assembly, University of Toyama
Division name	Department of Surgery and Science
Zip code	9300194
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Homepage URL
Email	isaku@med.u-toyama.ac.jp

Sponsor
Institute	Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Institute
Department

Funding Source
Organization	Department of Surgery and Science, Faculty of Medicine, Academic Assembly, 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	Center for Clinical Research, Toyama University Hospital
Address	2630, Sugitani, Toyama
Tel	076-434-7331
Email	rinri@adm.u-toyama.ac.jp

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	514
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	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 05 Day
Date of IRB	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 10 Month 10 Day
Last follow-up date	2022 Year 09 Month 30 Day
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	2021 Year 12 Month 28 Day

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