title: An endogastric capsule for measuring tumor markers in gastric juice: an evaluation of the safety and efficacy of a new diagnostic tool.
abstract: BACKGROUND
  In gastric juice, high levels of the carcinoembryonic antigen (CEA) and the carbohydrate antigen 19-9 (CA 19-9) have been found to correlate with precancerous lesions and gastric cancer. So far, sampling of gastric juice has required upper endoscopy. In place of this invasive procedure, we investigated a new tool for the quantitation of tumor markers in gastric juice.
  
  
  METHODS
  The study population consisted of healthy controls and consecutive subjects with suspected gastric cancer or dyspepsia/epigastric distress. Patients were asked to swallow a small gelatine capsule (14 mm in length and 5 mm in diameter) containing a pierced plastic cover and surrounding a piece of absorbent paper. The capsule was left in the gastric cavity for 60 min to allow saturation of the absorbent paper with gastric juice. A 45-50 cm length of nylon thread connected to the inner capsule was used to remove the device from the gastric cavity. After processing the absorbent paper for radioimmunoassay, CEA and CA 19-9 levels were correlated to the findings of upper endoscopy and biopsies of gastric mucosa or suspected lesions.
  
  
  RESULTS
  The endogastric capsule did not cause any side-effects and 62 participants were fully compliant to the procedure. Assessable gastric juice samples were taken from 23 patients with gastric cancer, 15 patients with intestinal metaplasia or dysplasia, 12 patients with gastritis and 12 controls without gastric diseases. In the 12 samples of gastric juice from control patients, mean values of CEA and CA 19-9 were 1.1 +/- 0.9 ng/ml and 16 +/- 7.5 ng/ml, respectively. The mean levels of both markers were found to increase according to the severity of gastric lesions and in patients with cancer, mean CEA and CA 19-9 levels were 513 +/- 627 ng/ml and 545 +/- 510 ng/ml, respectively. Patients with precancerous lesions and cancer showed higher levels of CEA and CA 19-9 than patients with normal findings or gastritis (P <0.001).
  
  
  CONCLUSIONS
  The endogastric capsule is a simple, non-invasive tool for the measurement of CEA and CA 19-9 levels in gastric juice. These values may discriminate between normal or minor pathologic changes and precancerous lesions or carcinomas. Further investigations are warranted, since this may represent a new method for gastric cancer screening.
authors.affiliation: Department of Histopathology, Azienda Ospedale S. Salvatore, Pesaro, Italy. p.muretto@ospedalesansalvatore.it
authors.forename: P
authors.initials: P
authors.lastname: Muretto
authors.forename: F
authors.initials: F
authors.lastname: Graziano
authors.forename: M P
authors.initials: MP
authors.lastname: Staccioli
authors.forename: I
authors.initials: I
authors.lastname: Barbanti
authors.forename: A
authors.initials: A
authors.lastname: Bartolucci
authors.forename: G
authors.initials: G
authors.lastname: Paolini
authors.forename: D
authors.initials: D
authors.lastname: Giordano
authors.forename: E
authors.initials: E
authors.lastname: Testa
authors.forename: A
authors.initials: A
authors.lastname: De Gaetano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018395:CA-19-9 Antigen / Q000032:analysis*; D002214:Capsules / Q000008:administration & dosage*; D002272:Carcinoembryonic Antigen / Q000032:analysis*; D016022:Case-Control Studies; D003937:Diagnosis, Differential; D004724:Endoscopy; D005260:Female; D005750:Gastric Juice / Q000737:chemistry*; D005756:Gastritis / Q000175:diagnosis / Q000276:immunology; D006801:Humans; D008297:Male; D008679:Metaplasia / Q000175:diagnosis / Q000276:immunology; D008875:Middle Aged; D009367:Neoplasm Staging; D011230:Precancerous Conditions / Q000175:diagnosis; D011446:Prospective Studies; D011863:Radioimmunoassay; D012307:Risk Factors; D012449:Safety; D013048:Specimen Handling; D013274:Stomach Neoplasms / Q000737:chemistry* / Q000175:diagnosis*
chemical_list: D018395:CA-19-9 Antigen; D002214:Capsules; D002272:Carcinoembryonic Antigen