UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026788 |
|---|---|
| Receipt number | R000030751 |
| Scientific Title | Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/04/01 17:36:56 |
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Basic information
Public title
Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration.
Acronym
Photodynamic diagnosis of Peritoneal disseminations of gastric cancer with 5-ALA.
Scientific Title
Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration.
Scientific Title:Acronym
Photodynamic diagnosis of Peritoneal disseminations of gastric cancer with 5-ALA.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a photodynamic diagnostic power for peritoneal dissemination of gastric cancer with 5-aminolevulinic acid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Additive effect to a photodynamic diagnostic power for peritoneal dissemination of gastric cancer with 5-ALA.
Key secondary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value of examination for peritoneal disseminated malignant nodules from primary gastric cancer using photodynamic diagnosis with 5-ALA.
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 |
Interventions/Control_1
5-aminolevulinic acid(5-ALA) is administered orally, 3-4 hours before start of an operation. Under general (and epidural) anesthesia and peumoperitoneum with carbon dioxide gas, laparoscopic examination is performed intraabdominally with blue-light exciting fluorescence and white-light. Observed by white-light only, blue-light only, and both white and blue-light, peritoneal nodules are snapshooted and counted. Some of them are excisional biopsied and confirmed their pathological diagnoses to compare with their photodynamic diagnoses.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have advanced gastric cancer with serosal invasion and scheduled a staging laparoscopy or a curative gastric resection.
Patients who signed informed consent.
Key exclusion criteria
Porphyria.
A history of photosensitivity.
Taking drugs that may cause photosensitivity.
Patients are judged to be inappropriate to participate in this study for any reason by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Imamura |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-323-5111
imamurakazu@mac.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Imamura |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-323-5111
Homepage URL
imamurakazu@mac.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel
0423235111
Kaori_Murase@member.metro.tokyo.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H280502001
Org. issuing International ID_1
Tokyo Metropolitan Government
Study ID_2
Org. issuing International ID_2
IND to MHLW
102
Institutions
Institutions
東京都立多摩総合医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
12
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
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030751
