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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043376
Receipt No. R000049524
Scientific Title A clinical role of staging laparoscopy in patients with pancreatic cancer
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/19

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Basic information
Public title A clinical role of staging laparoscopy in patients with pancreatic cancer
Acronym A clinical role of staging laparoscopy in patients with pancreatic cancer
Scientific Title A clinical role of staging laparoscopy in patients with pancreatic cancer
Scientific Title:Acronym A clinical role of staging laparoscopy in patients with pancreatic cancer
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the rate of occult distant organ metastasis, efficacy and safety of staging laparoscopy in patients with pancreatic cancer

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the rate of occult distant organ metastasis, and risk factors for occult distant metastasis
Key secondary outcomes Operation time, blood loss, complication, overall survival, disease free survival

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 no gender
2 age over 20 year old
3 patients who will undergo staging laparoscopy
4 no prior therapy
5 patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for the participation of this study
Key exclusion criteria 1 prior anti-cancer therapy
2 patients judged unsuitable as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nagano
Organization Yamaguchi University
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code 7558505
Address 1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL 0836-22-2264
Email geka2dm@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Yoshitaro
Middle name
Last name Shindo
Organization Yamaguchi University
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code 7558505
Address 1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL 0836-22-2264
Homepage URL
Email geka2dm@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center For Clinical Research, Yamaguchi University Hospital
Address 1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
Tel 0836-22-2428
Email ycrc@yamaguchi-u.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
2021 Year 02 Month 19 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
2020 Year 04 Month 28 Day
Date of IRB
2020 Year 06 Month 16 Day
Anticipated trial start date
2020 Year 06 Month 16 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
2025 Year 03 Month 31 Day
Date trial data considered complete
2025 Year 03 Month 31 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information To investigate the rate of occult distant organ metastasis, efficacy and safety of staging laparoscopy in patients with pancreatic cancer

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049524

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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