UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032184 |
|---|---|
| Receipt number | R000036305 |
| Scientific Title | Clinical study of diagnostic laparoscopy with 5 aminolevulinic acid mediated photodynamic diagnosis for the detection of peritoneal micrometastasis in hepatobiliary pancreatic tumor. |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2020/04/11 09:35:05 |
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Basic information
Public title
Clinical study of diagnostic laparoscopy with 5 aminolevulinic
acid mediated photodynamic diagnosis for the detection
of peritoneal micrometastasis in hepatobiliary pancreatic tumor.
Acronym
Clinical study of diagnostic laparoscopy with 5 aminolevulinic
acid mediated photodynamic diagnosis for the detection
of peritoneal micrometastasis in hepatobiliary pancreatic tumor.
Scientific Title
Clinical study of diagnostic laparoscopy with 5 aminolevulinic
acid mediated photodynamic diagnosis for the detection
of peritoneal micrometastasis in hepatobiliary pancreatic tumor.
Scientific Title:Acronym
Clinical study of diagnostic laparoscopy with 5 aminolevulinic
acid mediated photodynamic diagnosis for the detection
of peritoneal micrometastasis in hepatobiliary pancreatic tumor.
Region
| Japan |
Condition
Condition
hepatobiliary pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the 5 aminolevulinicacid mediated photodynamic diagnosis for detecting peritoneal metastases of hepatobiliary pancreatic tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive predictive value of photodynamic diagnosis using 5 ALA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Take 5ALA 3 hours before surgery
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
Patient scheduled for operation
Patients with high probability of peritoneal dissemination
It is deeper than the wall deepening degree T3 by preoperative diagnosis
Key exclusion criteria
Pregnant women or possibly breast-feeding patients
Patients with photosensitivity, history of porphyria, or family history
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokyo Women's Medical Universty
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
1628666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
yamamoto.masakazu@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Higuchi |
Organization
Tokyo Women's Medical Universty
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
1628666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
higuchi.ryota@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical Universty
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1 kawada-cho, Shinjuku-ku
Tel
81333538111
higuchi.ryota@twmu.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
| 2018 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2020 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036305
