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

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 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

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

Value
https://center6.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