UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

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

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)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

10

Month

21

Day

Last modified on

2021

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033874