Unique ID issued by UMIN | UMIN000009217 |
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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 |
Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Photodynamic diagnosis of gastrointestinal cancer
Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Photodynamic diagnosis of gastrointestinal cancer
Japan |
Gastrointestinal cancer
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
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.
Safety: The occurrence frequency and degree of adverse event were
investigated through the procedures.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Medicine | Device,equipment | Maneuver |
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.
20 | years-old | <= |
90 | years-old | > |
Male and Female
Patient who has primary and recurrent cancer of esophagus, stomach, colorectum, pancreas, liver, gallbladder and biliary tract.
Patients who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction.
50
1st name | Kazuhiro |
Middle name | |
Last name | Hanazaki |
Kochi Medical School
Department of Surgery, Kochi Medical School
783-8505
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
+81-88-880-2370
hanazaki@kochi-u.ac.jp
1st name | Tsutomu |
Middle name | |
Last name | Namikawa |
Kochi Medical School
Department of Surgery, Kochi Medical School
783-8505
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
+81-88-880-2370
http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
tsutomun@kochi-u.ac.jp
Department of Surgery, Kochi Medical School
None
Self funding
Ethical Review Boad of Kochi Medical School
Kochi Medical School
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
088-880-2370
im31@kochi-u.ac.jp
NO
高知大学医学部附属病院(高知県)
Kochi Medical School Hospital
2012 | Year | 10 | Month | 29 | Day |
Published
31
Completed
2012 | Year | 10 | Month | 26 | Day |
2012 | Year | 10 | Month | 26 | Day |
2012 | Year | 10 | Month | 30 | Day |
2021 | Year | 05 | Month | 05 | Day |
2012 | Year | 10 | Month | 29 | Day |
2021 | Year | 05 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010825
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