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Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)

Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg, Germany. Gastroenterology, University of Marburg, Marburg, Germany. Gastroenterology, Elisabeth-Krankenhaus-Essen, Essen, Germany. Gastroenterology, University of Leipzig, Leipzig, Germany. Gastroenterology, University of Ulm, Ulm, Germany. Gastroenterology, University of Würzburg, Würzburg, Germany. Gastroenterology, Sana Klinikum Offenbach, Offenbach, Germany. Gastroenterology, University of Göttingen, Göttingen, Germany. Gastroenterology, Helios Park-Klinikum Leipzig, Leipzig, Germany. Gastroenterology, University of Greifswald, Greifswald, Germany. Gastroenterology, University of Freiburg, Freiburg im Breisgau, Germany. Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg, Germany karel.caca@rkh-kliniken.de.

Gut. 2022
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PICO Summary

Population

High-risk patients with acute non-variceal upper gastrointestinal bleeding enrolled in the STING-2 trial (n= 100).

Intervention

First-line over-the-scope-clips therapy (OTSC group, n= 48).

Comparison

Standard endoscopic treatment (ST group, n= 52).

Outcome

Clinical success was 91.7% (44 patients) in the OTSC group compared with 73.1% (38 patients) in the ST group. Persistent bleeding occurred in 11.5% (6 patients) in the ST group, vs. zero patients in the OTSC group. Recurrent bleeding was observed in 8.3% (4 patients) in the OTSC group and in 15.4% (8 patients) in the ST group.
Abstract
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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine