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

INTERVENTION: 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. CONDITION: Gastrointestinal cancer PRIMARY OUTCOME: 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. SECONDARY OUTCOME: Safety: The occurrence frequency and degree of adverse event were ; investigated through the procedures. INCLUSION CRITERIA: Patient who has primary and recurrent cancer of esophagus, stomach, colorectum, pancreas, liver, gallbladder and biliary tract.