title: Preliminary study of photodynamic diagnosis using 5-aminolevulinic acid in gastric and colorectal tumors.
abstract: OBJECTIVE
  To investigate the utility of photodynamic diagnosis (PDD) using 5-aminolevulinic acid (5-ALA) to detect gastric/colorectal tumors.
  
  
  METHODS
  This prospective single-center study investigated inter-subject variability in patients with early-stage gastric/colorectal tumor indicated for endoscopic resection. Subjects were patients with gastric or colorectal tumors who had undergone endoscopic resection between November 2012 and November 2013. Selection criteria included age 20-80 years, either sex, and provision of informed consent. Patients were orally administered 20 mg/kg of 5-ALA enteric-coated capsules (SBI ALApromo Co., Tokyo, Japan). Administration of 5-ALA was followed by endoscopic resection of gastric or colorectal tumors, and the resected specimens were examined using a video autofluorescence processor and a fluorescence endoscope (SAFE-3000 and EB-1970AK, respectively; Pentax, Tokyo, Japan). The primary endpoint was the presence of fluorescence in tumors. Endoscopic, macroscopic, and histopathologic findings of tumors were assessed. We also evaluated adverse events of the present procedure as a secondary endpoint and examined each patient for the presence of known adverse effects of 5-ALA, namely, hematocytopenia, liver dysfunction, hypotension, nausea, and photosensitivity.
  
  
  RESULTS
  We enrolled 10 patients (7 men, 3 women) (n = 13 lesions: 10 gastric/3 colorectal tumors). Fluorescence was detected in 7/13 (53.8%) lesions. No significant differences in sex (male: 55.6% vs female: 50.5%, P = 1.00), age (67.1 ± 1.9 years vs 65.0 ± 2.0 years, P = 0.45), tumor color (reddish: 60.0% vs discolored: 33.3%, P = 0.56), tumor diameter (15.0 ± 2.1 mm vs 14.2 ± 2.3 mm, P = 0.80), macroscopic type (protruded: 70.0% vs depressed 0%, P = 0.07), histologic type (differentiated type: 58.3% vs 0%, P = 0.46), invasion depth (mucosal layer: 55.6% vs submucosal layer: 33.3%, P = 1.00), lymphatic invasion (present: 33.3% vs absent: 50.0%, P = 1.00), venous invasion (present: 0% vs absent: 54.5%, P = 1.00) or procedure time of endoscopic resection (36.3 ± 8.3 min vs 36.7 ± 9.0 min, P = 0.98) were observed between the patients with and without fluorescence. Fluorescence detection rate tended to be high for elevated lesions. Liver dysfunction developed in 4/10 (40.0%) patients. The extent of the liver dysfunction was a slight increase in transaminases and total bilirubin levels, which spontaneously improved in the patients. None of the patients developed photosensitivity.
  
  
  CONCLUSIONS
  Results of this preliminary study suggest the utility of PDD using 5-ALA for screening of gastric and colorectal cancers.
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Munetaka
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Nishikawa
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Kouichi
authors.initials: K
authors.lastname: Hamabe
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Goto
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Nishimura
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Shibata
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Misato
authors.initials: M
authors.lastname: Nagao
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Sho
authors.initials: S
authors.lastname: Sasaki
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hashimoto
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Okamoto
authors.affiliation: Munetaka Nakamura, Jun Nishikawa, Kouichi Hamabe, Atsushi Goto, Junichi Nishimura, Hiroaki Shibata, Misato Nagao, Sho Sasaki, Shinichi Hashimoto, Takeshi Okamoto, Isao Sakaida, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755-8505, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Sakaida
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D003082:Colectomy; D020685:Colonoscopes; D003113:Colonoscopy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D004867:Equipment Design; D005260:Female; D005456:Fluorescent Dyes / Q000008:administration & dosage* / Q000009:adverse effects; D005743:Gastrectomy; D020699:Gastroscopes; D005773:Gastroscopy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D061848:Optical Imaging; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery
chemical_list: D002214:Capsules; D005456:Fluorescent Dyes; D000622:Aminolevulinic Acid
keywords: 5-aminolevulinic acid; Colorectal tumor; Photodynamic diagnosis; Protoporphyrin IX, Gastric tumor