Efficacy of Per-oral Methylene Blue Formulation for Colonoscopy Detection of Non-polypoid Colorectal Neoplasms: A Randomized Clinical Trial

Aims Non-polypoid colorectal neoplasms (NP-CRNs) are associated with a higher risk of malignant transformation, while their morphology poses a challenge in their detection during colonoscopy compared to protruded lesions. This trial is set to assess whether the use of methylene blue (MB) with a per-oral, colon-release, pH- and time-dependent multimatrix structure (MB-MMX) could enhance the detection of NP-CRNs during colonoscopy [1] [2] [3] [4] [5] [6] [7].

Methods This multicenter, placebo-controlled, randomized, double-blind, phase III trial was conducted between January 6, 2022, and September 15, 2022, at 19 hospitals in China and involved individuals undergoing CRC screening or surveillance colonoscopy.1802 participants were randomly assigned to receive either 200 mg of MB-MMX or placebo tablets orally along with bowel preparation. The primary outcome was the detection rate of NP-CRNs, defined as the proportion of participants with at least one histologically confirmed NP-CRN. Key secondary outcomes included the non-polypoid adenoma detection rate (NP-ADR) (defined as the proportion of participants with at least one histologically confirmed non-polypoid adenoma), the mean number of NP-CRNs, false positive rate, and safety.

Results Oral administration of MB-MMX significantly increased the detection rate of NP-CRNs, with rates of 51.0% in the MB-MMX group compared to 41.2% in the placebo group, indicating an 8.8% absolute increase in the full analysis set. Moreover, the NP-ADR was significantly higher in the MB-MMX group (39.1%) than in the placebo group (30.9%). The mean number of NP-CRNs per person was also significantly higher in the MB-MMX group (0.9) compared to the placebo group (0.7). There was no significant difference in the false-positive rate between the MB-MMX and placebo groups. The oral administration of 200 mg MB-MMX with bowel preparation was well-tolerated, with comparable rates of adverse events between the MB-MMX and placebo groups, and no new safety concerns emerged.

Conclusions The study demonstrates that orally administering 200 mg of MB-MMX with bowel preparation effectively enhances the detection of NP-CRNs, with clinical relevance in potentially reducing post-colonoscopy CRC incidence and mortality.

Publikationsverlauf

Artikel online veröffentlicht:
27. März 2025

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