Higher efficacy of over-the-scope clips compared to through-the-scope clips for first-line endoscopic treatment of acute peptic ulcer bleeding: results of an international, multi-center, randomized controlled trial

Aims First-line over-the-scope clip (OTS-clip) treatment has shown higher efficacy than standard endoscopic therapy in acute non-variceal upper GI bleeding from several different causes [1] [2]. However, no randomized controlled trial (RCT) comparing first-line mechanical treatment with OTS-clip vs through-the-scope clips (TTSCs) in the specific setting of peptic ulcer (PU) bleeding has been performed to date. This was our study aim (▶Table [1]).

Table 1 Demographic and clinical patients' characteristics..

Methods This study was awarded the 2019 ESGE research grant. We conducted an international, multi-center RCT on consecutive patients with suspected upper GI bleeding (NCT03551262). In case of Forrest Ia-IIb gastroduodenal PU, patients were randomized to OTS-clip or TTSC treatment. Primary outcomes were technical success, 30-day rebleeding and overall clinical success (defined as technical success without evidence of 30-day rebleeding) rates.

Results 251 patients were screened and 112 patients were finally randomized to OTS-clip (n=61) or TTSC (n=51) treatment. Patients' characteristics are shown in Table 1. Technical success was achieved in 98.4% (60/61) and 78.4% (40/51) of patients treated with OTS-clip or TTSC, respectively (p=0.001). TTSC failure was related to fibrotic PU (7/11), posterior duodenal wall location (3/11) and large-size visible bleeding vessel (1/11). When technical success was obtained, 30-day rebleeding occurred in 1.7% (1/60) and 5.0% (2/40) of OTS-clip and TTSC-treated patients, respectively (p=0.562). Overall clinical success rate was 96.7% (59/61) in the OTS-clip group compared to 74.5% (38/51) in the TTSC group (p=0.0006).

Conclusions Compared to TTSC, OTS-clip showed higher efficacy as first-line endoscopic treatment of acute PU bleeding, both in terms of technical and overall clinical success rates.

 

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Conflicts of interest

Authors do not have any conflict of interest to disclose.

• 1 Meier B, Wannhoff A, Denzer U. et al. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2). Gut 2022; 71: 1251-1258
• 2 Jensen DM, Kovacs T, Ghassemi KA. et al. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol 2021; 19: 2315-2323

Publication History

Article published online:
14 April 2023