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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029615
Receipt No. R000033830
Scientific Title Mesenteric approach vs. conventional approach for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial)
Date of disclosure of the study information 2017/10/18
Last modified on 2019/02/24

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Basic information
Public title Mesenteric approach vs. conventional approach for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial)
Acronym MAPLE-PD trial
Scientific Title Mesenteric approach vs. conventional approach for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial)
Scientific Title:Acronym MAPLE-PD trial
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 NO

Objectives
Narrative objectives1 To evaluate the advantage of mesenteric approach during pancreaticoduodenectomy for pancreatic ductal adenocarcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes operative time, time for resection, intraoperative blood loss, blood transfusion volume, grade B/C pancreatic fistula rate, DGE rate, abdominal hemorrhage rate, all morbidity rate, mortality rate, diarrhea rate, R0 rate, R1 rate, the closest length between surgical margin and cancer cell, number of harvesteed lymph nodes, number of metastatic lymph nodes, lymph node ratio, Recurrence free survival, site of initial recurrence

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, which starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy
Interventions/Control_2 Control group: conventional approach, which starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery 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 cirrhsis 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 understant ths 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 gadolinum
Target sample size 354

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
Institute Second Department of Surgery, Wakayama Medical University
Institute
Department

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 Oosaka Medical University, Oosaka University, Kagoshima University, Kansai Medical University, Kyusyu 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 18 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 18 Day
Last modified on
2019 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033830

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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