UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043376 |
|---|---|
| Receipt number | 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 12:20:36 |
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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
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
geka2dm@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049524
