UMIN-CTR Clinical Trial

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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