Over-the-scope clip as first-line treatment of peptic ulcer bleeding: is it suitable for all?

In this issue of Endoscopy, Soriani et al. [1] evaluate the efficacy of over-the-scope (OTS) clips versus through-the-scope (TTS) clips as a primary treatment in Forrest Ia–IIb peptic ulcer bleeding. They conducted a multicenter, randomized controlled trial (RCT) in four Italian and one Spanish center. This was the first trial to provide head-to-head comparison between two mechanical modalities in endoscopic hemostatic treatment for high risk peptic ulcer bleeding. The negative result of the 30-day rebleeding rate after successful initial hemostasis was 1.6% (1/61) and 3.9% (2/51) for patients treated with OTS clips and TTS clips, respectively (RR = 0.42, 95%CI 0.04–4.53; P=0.47). However, the successful initial hemostasis and overall clinical success rates were higher in the OTS clip group than in the TTS clip group (98.4% vs. 78.4%, P=0.001; 96.7% vs. 74.5%, P=0.001, respectively) with an absolute risk reduction of 20%.

“These data support the recommendation of the ESGE guideline to use over-the-scope clips as the primary treatment only in selected patients with peptic ulcer bleeding who have a high risk of hemostatic failure with through-the scope clips.”

This study emphasizes an important factor for successful initial hemostasis and overall clinical success, which is the expertise of the endoscopist. The study included only experienced endoscopists who had already placed 30 or more OTS clips, resulting in near perfect initial hemostasis and overall clinical success in the OTS clip group. This information was supported by our previous trial, which concluded that OTS clips could be helpful as a primary hemostasis modality in large (≥1.5cm) bleeding peptic ulcers only in experienced hands [2]. Other previous RCTs on this topic [3] [4] have also emphasized the need for endoscopist experience in OTS clip use by setting a protocol of a 2-week OTS clip training program [3] or including only endoscopists who performed ≥20 OTS clip applications per year [4] in the study. Therefore, the results of the Soriani et al. study might not be applicable to general endoscopists. The learning curve for the use of OTS clips is warranted to ensure excellent outcomes for initial hemostasis.

Compared with TTS clips, OTS clips can capture a larger amount of tissue and anchor onto the base of the fibrotic ulcer, and therefore have a higher clip retention rate [5]. The nitinol clip has a high tensile strength and compresses the bleeding artery firmly [5]. Brandler et al. reported three characteristics of actively bleeding ulcers that would make OTS clip use appropriate at the index endoscopy: 1) size >2cm plus a vessel ≥2mm; 2) location around the major arteries (posterior wall of the duodenal bulb and lesser curvature of the body); and 3) presence of a deep, excavated, or fibrotic base [6]. Consequently, the European Society of Gastrointestinal Endoscopy (ESGE) suggest using a cap-mounted clip in these three scenarios as first-line treatment (weak recommendation, low quality of evidence) [7]. In the current study, among patients with failed TTS clip hemostasis (n=11), the majority (7/11; 63.6%) had fibrotic-based ulcers, 3/11 (27.3%) had ulcers at the posterior wall of the duodenal bulb, and one patient (9.1%) had a large vessel [1]. Subsequently, all 11 patients underwent successful endoscopic hemostasis with OTS clip application [1]. These data support the recommendation of the ESGE guideline to use OTS clips as the primary treatment only in selected patients who have a high risk of hemostatic failure with TTS clips.

In summary, OTS clips should not be used routinely as a first-line endoscopic hemostatic method for peptic ulcer bleeding. Patients with fibrotic-based or large ulcers sitting on top of a large vessel or ulcers at a high risk location may be selected for OTS clip application as an initial treatment, as these patients would benefit from this approach without being overtreated.

Publication History

Article published online:
24 June 2024

• References

• 1 Soriani P, Biancheri P, Bonura GF. et al. Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicenter randomized controlled trial (TOP Study). Endoscopy 2024; 56
• 2 Chan S, Pittayanon R, Wang HP. et al. Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.5 cm): an open-labelled, multicentre international randomised controlled trial. Gut 2023; 72: 638-643
• 3 Lau JYW, Li R, Tan CH. et al. Comparison of over-the-scope clips to standard endoscopic treatment as the initial treatment in patients with bleeding from a nonvariceal upper gastrointestinal cause: a randomized controlled trial. Ann Intern Med 2023; 176: 455-462
• 4 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
• 5 Pittayanon R, Lau JYW. Strategies to pre-empt recurrent bleeding after endoscopic hemostasis. Gastrointest Endosc 2021; 93: 1238-1240
• 6 Brandler J, Baruah A, Zeb M. et al. Efficacy of over-the-scope clips in management of high-risk gastrointestinal bleeding. Clin Gastroenterol Hepatol 2018; 16: 690-696.e1
• 7 Gralnek IM, Stanley AJ, Morris AJ. et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline – update 2021. Endoscopy 2021; 53: 300-332