Objectives In the management of patients with bleeding peptic ulcers, recurrent bleeding is associated with high mortality. We investigated if added angiographic embolisation after endoscopic haemostasis to high-risk ulcers could reduce recurrent bleeding.
Design After endoscopic haemostasis to their bleeding gastroduodenal ulcers, we randomised patients with at least one of these criteria (ulcers≥20 mm in size, spurting bleeding, hypotensive shock or haemoglobin<9 g/dL) to receive added angiographic embolisation or standard treatment. Our primary endpoint was recurrent bleeding within 30 days.
Results Between January 2010 and July 2014, 241 patients were randomised (added angiographic embolisation n=118, standard treatment n=123); 22 of 118 patients (18.6%) randomised to angiography did not receive embolisation. In an intention-to-treat analysis, 12 (10.2%) in the embolisation and 14 (11.4%) in the standard treatment group reached the primary endpoint (HR 1.14, 95% CI 0.53 to 2.46; p=0.745). The rate of reinterventions (13 vs 17; p=0.510) and deaths (3 vs 5, p=0.519) were similar. In a per-protocol analysis, 6 of 96 (6.2%) rebled after embolisation compared with 14 of 123 (11.4%) in the standard treatment group (HR 1.89, 95% CI 0.73 to 4.92; p=0.192). None of 96 patients died after embolisation compared with 5 (4.1%) deaths in the standard treatment group (p=0.108). In a posthoc analysis, embolisation reduced recurrent bleeding only in patients with ulcers≥15 mm in size (2 (4.5%) vs 12 (23.1%); p=0.027).
Conclusions After endoscopic haemostasis, added embolisation does not reduce recurrent bleeding.
Trial registration number NCT01142180.
- peptic ulcer bleeding
- angiographic treatment
- endoscopic treatment
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Contributors JYWL has full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. JYWL and RP are both first authors. Concept and design: JYWL, RP, K-TW, NP, PWYC, RR, ILH, EJK, K-CW, KWLA, FKLC, JJYS. Acquisition, analysis or interpretation of data: JYWL, RP, K-TW, NP, PWYC, RR, ILH, EJK, K-CW, KWLA, FKLC, JJYS. Drafting of the manuscript: JYWL. Critical revision of the manuscript for important intellectual content: JYWL, RP, K-TW, NP, PWYC, RR, ILH, EJK, K-CW, KWLA, FKLC, JJYS. Statistical analysis: KWLA. Obtained funding: JYWL. Administrative technical or material support: JYWL, RP, K-TW, NP, PWYC, RR, ILH, EJK, K-CW, KWLA, FKLC, JJYS. Study supervision: JYWL, RP, ILH, K-CW.
Funding Hong Kong SAR Government Research Grant.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The New Territories East Cluster Hospitals Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.