UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029615 |
|---|---|
| Receipt number | 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 | 2021/10/21 09:17:21 |
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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 | 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
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
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, 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033830
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