UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009217
Receipt number R000010825
Scientific Title Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Date of disclosure of the study information 2012/10/29
Last modified on 2021/05/05 09:44:51

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Basic information

Public title

Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)

Acronym

Photodynamic diagnosis of gastrointestinal cancer

Scientific Title

Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)

Scientific Title:Acronym

Photodynamic diagnosis of gastrointestinal cancer

Region

Japan


Condition

Condition

Gastrointestinal cancer

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the value of the photodynamic diagnosis (PDD) of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) including safety and usefulness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results. The diagnostic capability of photodynamic diagnosis (PDD) using fluorescence (blue light) endoscopy was compared to that in conventional diagnostic method.

Key secondary outcomes

Safety: The occurrence frequency and degree of adverse event were
investigated through the procedures.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment Maneuver

Interventions/Control_1

Two to two and half hours prior to endoscopy 1.5g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 8.4% sodium hydrogen carbonate (NaHCO3) solution was administrated orally (1.0g/50ml) or instilled intravesically (1.5g/50ml).
For fluorescence excitation a blue light source (D-LIGHT System, Karl Storz Endoscopy Japan K.K.) was used.
Under white and fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), tumor locations were recorded.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patient who has primary and recurrent cancer of esophagus, stomach, colorectum, pancreas, liver, gallbladder and biliary tract.

Key exclusion criteria

Patients who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kazuhiro
Middle name
Last name Hanazaki

Organization

Kochi Medical School

Division name

Department of Surgery, Kochi Medical School

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan

TEL

+81-88-880-2370

Email

hanazaki@kochi-u.ac.jp


Public contact

Name of contact person

1st name Tsutomu
Middle name
Last name Namikawa

Organization

Kochi Medical School

Division name

Department of Surgery, Kochi Medical School

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan

TEL

+81-88-880-2370

Homepage URL

http://www.kochi-ms.ac.jp/~fm_srgr1/index.html

Email

tsutomun@kochi-u.ac.jp


Sponsor or person

Institute

Department of Surgery, Kochi Medical School

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ethical Review Boad of Kochi Medical School

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kochi Medical School

Address

Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan

Tel

088-880-2370

Email

im31@kochi-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

高知大学医学部附属病院(高知県)
Kochi Medical School Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

31

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

2012 Year 10 Month 26 Day

Date of IRB

2012 Year 10 Month 26 Day

Anticipated trial start date

2012 Year 10 Month 30 Day

Last follow-up date

2021 Year 05 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 10 Month 29 Day

Last modified on

2021 Year 05 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name