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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026788
Receipt No. 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

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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
Email 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
Email imamurakazu@mac.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030751

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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