Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicentre randomized controlled trial (TOP Study)

Background: First-line over-the-scope-clip (OTSC) treatment has shown higher efficacy than standard endoscopic therapy in acute non-variceal upper gastrointestinal bleeding (UGIB) from different causes. We performed a head-to-head randomized controlled trial (RCT) comparing OTSC vs through-the-scope-clip (TTSC) as first-line mechanical treatment in the specific setting of peptic ulcer (PU) bleeding. Methods: We conducted an international, multicenter RCT on consecutive patients with suspected UGIB. In case of Forrest Ia-IIb gastroduodenal PU, patients were randomized 1:1 to OTSC or TTSC treatment. The primary outcome was the rate of 30-day rebleeding after successful initial hemostasis. Secondary outcomes included successful initial hemostasis and overall clinical success rates, defined as the composite of successful initial hemostasis and no evidence of 30-day rebleeding. Results: 251 patients were screened and 112 patients were finally randomized to OTSC (n=61) or TTSC (n=51) treatment. 30-day rebleeding rates were 1.6% (1/61) and 3.9% (2/51) for OTSC- and TTSC-treated patients, respectively (Kaplan-Meier log-rank, p = 0.458). Successful initial hemostasis rates were 98.4% (60/61) in the OTSC group and 78.4% (40/51) in the TTSC group (p=0.001). Eventually, overall clinical success rates were 96.7% (59/61) in the OTSC group and 74.5% (38/51) in the TTSC group (p=0.001). Conclusions: Low rates of 30-day rebleeding were observed after first-line endoscopic treatment of acute PU bleeding with either OTSC or TTSC. However, OTSC showed higher efficacy than TTSC in achieving successful initial hemostasis and overall clinical success.

Publication History

Received: 21 July 2023

Accepted after revision: 10 April 2024

Accepted Manuscript online:
10 April 2024