RT Journal Article
SR Electronic
T1 Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 1251
OP 1258
DO 10.1136/gutjnl-2021-325300
VO 71
IS 7
A1 Benjamin Meier
A1 Andreas Wannhoff
A1 Ulrike Denzer
A1 Petros Stathopoulos
A1 Brigitte Schumacher
A1 David Albers
A1 Albrecht Hoffmeister
A1 Jürgen Feisthammel
A1 Benjamin Walter
A1 Alexander Meining
A1 Edris Wedi
A1 Markus Zachäus
A1 Tilman Pickartz
A1 Armin Küllmer
A1 Arthur Schmidt
A1 Karel Caca
YR 2022
UL http://gut.bmj.com/content/71/7/1251.abstract
AB Objective Acute non-variceal upper gastrointestinal bleeding (NVUGIB) 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 our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients.Design We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding.Results 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one 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 ST group (p=0.019), with persistent bleeding occurring in 0 vs 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 four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362).Conclusion OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis.Trial registration number NCT03331224.All data relevant to this study are included in the article or uploaded as supplementary information.