UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029658
Receipt number R000033889
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
Date of disclosure of the study information 2017/10/22
Last modified on 2019/02/24 14:31:49

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Basic information

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

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


Objectives

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



Assessment

Primary outcomes

circulating tumor DNA volume obtained from portal vein duirng pancreaticoduodenectomy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Second Department of Surgery, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Second Department of Surgery, Wakayama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

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)



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 10 Month 22 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name