A Retrospective Analysis to Validate the Alarm Signs Used in the CEDAP-Plus Study

Background and Study Aim . This study aimed to validate the alarm signs used in the 2007 German CEDAP-Plus study for indicating capsule endoscopy in patients who have idiopathic chronic abdominal pain. Patients and Methods . We retrospectively reviewed the cases of all patients who underwent capsule endoscopy at our institution between August 2007 and August 2009 for chronic hitherto undiagnosed abdominal pain, despite previous investigations. The demographic data, indications, findings, and diagnoses were recorded, as were the alarm signs (i.e., 10% loss of weight within 3 months, suspected small intestinal bleed or chronic anemia, and laboratory indications of inflammation). Results . Alarm signs were found in only 4 of the 62 included patients. Capsule endoscopy revealed findings that led to diagnoses of Crohn's disease ( n = 4), tuberculosis ( n = 1), gastrointestinal stromal tumors ( n = 3), and hookworm ( n = 1); these diagnoses included 100% (4/4) of the patients with alarm signs, but only 8.6% (5/58) of patients without them. However, 55.6% (5/9) of patients with clinically capsule endoscopy findings reported no alarm signs. Conclusions . Although selecting patients based on the alarm signs may increase the yield of capsule endoscopy, the alarm sign criteria appear to have low sensitivity.