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BACKGROUND & AIMS: Topically applied methylene blue dye chromoendoscopy is effective in improving detection of colorectal neoplasia. When combined with a pH- and time-dependent multi-matrix structure, a per-oral methylene blue formulation (MB-MMX) can be delivered directly to the colorectal mucosa. METHODS: We performed a phase 3 study of 1205 patients scheduled for colorectal cancer screening or surveillance colonoscopies (50-75 years old) at 20 sites in Europe and the United states, from December 2013 through October 2016. Patients were randomly assigned to groups given 200 mg MB-MMX, placebo, or 100 mg MB-MMX (ratio of 2:2:1). The 100 mg MB-MMX group included for masking purposes. MB-MMX and placebo tablets were administered with a 4-liter polyethylene glycol-based bowel preparation. The patients then underwent colonoscopy by an experienced endoscopist with centralized double-reading. The primary endpoint was the proportion of patients with 1 adenoma or carcinoma (adenoma detection rate [ADR]). We calculated odds ratio (OR) and 95% CIs for differences in detection between the 200 mg MB-MMX and placebo groups. False-positive (resection rate for non-neoplastic polyps) and adverse events were assessed as secondary endpoints. RESULTS: The ADR was higher for the MB-MMX group (273/485 patients, 56.29%) than the placebo group (229/479 patients, 47.81%) (OR, 1.46; 95% CI, 1.09-1.96). The proportion of patients with nonpolypoid lesions was higher in the MB-MMX group (213/485 patients, 43.92%) than the placebo group (168/479 patients, 35.07%) (OR, 1.66; 95% CI, 1.21-2.26). The proportion of patients with adenomas <5 mm was higher in the MB-MMX group (180/485 patients, 37.11%) than the placebo group (148/479 patients, 30.90%) (OR, 1.36; 95% CI, 1.01-1.83), but there was no difference between groups in detection of polypoid or larger lesions. The false-positive rate did not differ significantly between groups (83/356 patients with non-neoplastic lesions, 23.31% in the MB-MMX vs 97/326 patients with non-neoplastic lesions, 29.75% in the placebo group). Overall, 0.7% of patients had severe adverse events but there was no significant difference between groups. CONCLUSIONS: In a phase 3 trial of patients undergoing screening or surveillance colonoscopies, we found MB-MMX led to an absolute 8.5% increase in ADR, compared to placebo, without increasing the removal of non-neoplastic lesions. no: NCT01694966.

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chromoendoscopy, colon cancer, endoscopy, visualization