OTSC® – RCT proves OTSC® is superior as first-line treatment in ulcer bleeding

Multicenter, randomized controlled trial shows higher efficacy of OTSC^® in obtaining successful hemostasis in peptic ulcers compared to through-the-scope clips (TTSC).

Key findings
• Initial hemostasis rate was 98.4% with OTSC, 78.4% with TTSC (p=0.001)
• Clinical success, defined as the composite of successful initial hemostasis and no evidence of rebleeding within a 30-day period was 96.7% with OTSC vs 74.5% with TTSC (p=0.001).
• 30-day rebleeding rate was low for both OTSC (1.6%) and TTSC (3.9%) (p=0.458)
• Study shows higher efficacy of initial hemostasis as well as overall success of OTSC as first-line treatment for peptic ulcers as compared to TTSC

Study details
• 251 patients in 5 European centers were assessed for eligibility, of which 112 were enrolled in the study
• Patients were randomized to the OTSC group (n=61) or the TTSC group (n=51)
• Only patients with Forrest Ia-IIb gastroduodenal peptic ulcers were enrolled in the study
• In case of no clinical success, the endoscopist was allowed to choose any rescue endoscopic treatment
• Generalized linear model with log-binominal distribution confirmed that OTSC had a 25% higher efficacy compared to TTSC in obtaining successful hemostasis (p=0.003).

Soriani P, Biancheri P, Bonura GF, Gabbani T, Rodriguez de Santiago E, Dioscoridi L, Andrisani G, Luigiano C, Deiana S, Rainer J, Del Buono M, Amendolara R, Marino M, Hassan C, Repici A, Manno M. Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicentre randomized controlled trial (TOP Study). Endoscopy. 2024 Apr 10. doi: 10.1055/a-2303-4824. Epub ahead of print.

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Yours sincerely,
the team from the Ovesco Scientific Information Service