UMIN-CTR Clinical Trial

Public title

Accompanying research of mesenteric approach vs.conventional for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial): Evaluation of circulating tumor DNA in portal vein

Acronym

Accompanying reserach of MAPLE-PD trial: Evaluation of circulating tumor DNA in portal vein

Scientific Title

Accompanying research of mesenteric approach vs.conventional for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial): Evaluation of circulating tumor DNA in portal vein

Scientific Title:Acronym

Accompanying reserach of MAPLE-PD trial: Evaluation of circulating tumor DNA in portal vein

Region

Japan

Condition

Patients who are scheduled to undergo pancreaticoduodenectomy for resectable or BR-PV pancreatic ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Comparison of circulating tumor DNA in portal vein between mesenteric approach and conventional approach duiring pancreaticoduodenectomy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

circulating tumor DNA volume obtained from portal vein duirng pancreaticoduodenectomy

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Interventional group: mesenteric approach during pancreaticoduodenectomy

Interventions/Control_2

Control group: conventional approach during pancreaticoduodenectomy

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or BR-PV pancreatic ductal adenocarcinoma.
2)Patients whose ECOG performance status are 0 or 1.
3)Patients who are 20 years or older.
4)Patients who have adequate organ function.
5)Patients who understand sufficiently the study to provide written informed consent

Key exclusion criteria

1)Patients who have severe ischemic cardiovascular disease
2)Patients who have liver cirrhosis or active hepatitis
3)Patients who need oxygen due to interstitial pneumonia or lung fibrosis
4)Patients who receive dialysis due to chronic renal failure
5)Patients who need surrounding organ resection
6)Patients who need artery reconstruction
7)Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging
8)Patients who have active multiple cancer that is thought to influence the occurrence of adverse events
9)Patients who take steroid for the long period that is thought to influence the occurrence of adverse events
10)Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy
11)Patients who cannot understand the study due to psychotic disease or psychological symptoms
12)Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma
13)Patients who underwent gastrectomy or colon/ rectum resection previously
14)Patients who have severe drug allergy to iodine and gadolinium

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Hiroki Yamaue

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Email

yamaue-h@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Seiko Hirono

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Homepage URL

Email

seiko-h@wakayama-med.ac.jp

Institute

Second Department of Surgery, Wakayama Medical University

Institute

Department

Personal name

Organization

Second Department of Surgery, Wakayama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Osaka Medical University, Osaka University, Kagoshima University, Kansai Medical University, Kyushu University, Kinki University, Kumamoto University, Shiga Medical University, Shimane University, Tokyo Medical University, Toyama University, Nara Medical University, Nagoya University, Hiroshima University

Name of secondary funder(s)

Organization

Address

Tel

Email

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

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

22

Day

Last modified on

2019

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033889