Esophagus to Small Intestine
Over-the-scope clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: A randomized controlled trial (STING-2)
Objective: Acute non-variceal upper gastrointestinal bleeding (UGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of the present study was to compare first-line over-the-scope clips (OTSC) therapy with standard endoscopic treatment in these selected patients.
Design: The authors conducted a prospective, randomized, controlled, multicenter study. Patients with endoscopic evidence of acute non-variceal UGIB and high risk of rebleeding (defined as complete Rockall Score ≥ 7) were included. Primary end point was clinical success defined as successful endoscopic hemostasis without evidence of recurrent bleeding.
Results: 246 patients were screened and 100 patients were finally randomized (mean of 5 cases/center and year; 70% male, 30% female, mean age 78 years; OTSC group, n = 48; standard group, n = 52). All but 1 case in the standard group were treated with conventional clips. Clinical success was 91.7% (n = 44) in the OTSC group compared with 73.1% (n = 38) in the standard treatment group (p = 0.019), with persistent bleeding occurring in 0 versus 6 in the OTSC versus standard group (p = 0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in 4 patients (8.3%) in the OTSC group and in 8 patients (15.4%) in the standard group (p = 0.362).
Conclusion: Over-the-scope clips (OTSC) therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of non-variceal upper gastrointestinal bleeding with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC hemostasis.