UMIN-CTR Clinical Trial

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 Hiroki Middle name Last name Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
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 Hirono Middle name Last name Seiko
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
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	Osaka 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, Gunma Univesity, Tsukuba University, Nagasaki University, Tokyo Medical and Dental University, Yokohama City University, Chiba University, Kyoto Prefectural University, Tohoku University, St. Marianna University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakayama Medical University
Address	811-1 Kimiidera Wakayama
Tel	073-441-0613
Email	wa-rinri@wakayama-med.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 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	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 02 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2023 Year 03 Month 31 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 18 Day
Last modified on	2021 Year 10 Month 21 Day

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