Prospective multicenter trial of capsule encloscopy in patients with chronic abdominal pain, diarrhea and other signs and symptoms (CEDAP-Plus Study)

Background: On the basis of the published data, capsule endoscopy cannot be recommended in patients whose only symptom is chronic abdominal pain. The present study therefore focused on the diagnostic yield of capsule endoscopy in patients with chronic abdominal pain who were also suffering from additional symptoms. Patients and methods: A total of 50 patients with chronic abdominal pain, plus other symptoms singly or in combination were enrolled in this prospective multicenter trial. The "plus" symptoms or signs consisted of weight loss (> 10 % of body weight), inflammation shown by laboratory tests, chronic anemia, or suspected mid-gastrointestinal bleeding. Chronic diarrhea was recorded if present, but patients did not qualify for the study if they had pain and diarrhea alone. Capsule endoscopy was carried out following a defined previous diagnostic work-up that had not revealed the cause of the patient's symptoms. The capsule videos were assessed by two independent blinded investigators. The findings were classified as relevant, potentially relevant, or not relevant for explaining the symptoms, or else classified as normal. Results: The capsule reached the cecum in 84% of the patients (42 of 50). Relevant findings were discovered on capsule endoscopy in 36% and 40% of patients by the two investigators, and potentially relevant findings in 14% and 24% of patients. The additional symptom or sign of inflammation was associated with the highest diagnostic yield (odds ratio 3.2). The presence of more than one additional symptom did not increase the yield in our patient group. Two capsules (4%) entrapped at previously unrecognized stenoses were removed endoscopically using pushand-pull enteroscopy (n = 1) or surgery (n = 1). Conclusions: Strict patient selection on the basis of additional symptoms or signs is the key to increasing the yield of capsule endoscopy in patients with chronic abdominal pain. Inflammation seemed to be the additional sign with the highest value.