Over-the-scope clip does not prevent 30-day rebleeding in patients with peptic ulcers
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Routine use of over-the-scope clip as primary hemostasis did not decrease 30-day rebleeding compared with conventional therapy in patients with bleeding peptic ulcers at least 15 mm in size, according to research published in Gut.
“Acute upper GI bleeding is a common and potentially life-threatening condition,” Shannon Chan, MBChB, FRCSEd, FCSHK, FKAM, assistant professor of upper gastrointestinal and metabolic surgery at The Chinese University of Hong Kong, and colleagues wrote. “Endoscopic hemostasis has significantly improved the outcome of these patients. Despite acid suppression and endoscopic treatment, 10% to 20% of patients continue to bleed or develop rebleeding. Recurrent bleeding remains one of the most important predictors of mortality.”
According to researchers, physicians have conventionally achieved endoscopic hemostasis by injection therapy, thermocoagulation or mechanical therapy, such as hemostatic clips. The over-the-scope clip (OTSC) now available is a novel endoscopic clipping device that provides “strong tissue apposition with a larger jaw width and greater strength.”
Seeking to compare OTSC with standard therapy for primary hemostasis, Chan and colleagues enrolled 100 patients with high-risk bleeding peptic ulcers, at least 15 mm in size, in an open-label, multicenter international trial. Patients were included if they had actively bleeding peptic ulcers (Forrest Ia and Ib), ulcers with a non-bleeding visible vessel or Forrest IIa ulcers greater than or equal to 15 mm in size.
Studied outcomes included 30-day rebleeding, 3-day all-cause mortality, transfusion requirement, hospital stay, technical/clinical success and further intervention. There were 50 patients in each study arm.
According to study results, 92% of patients in the OTSC arm and 96% in the standard therapy arm achieved primary hemostasis. Among those who achieved primary hemostasis, 4.35% and 18.75%, respectively, experienced 30-day rebleeding.
In the intention to treat analysis, researchers reported no difference in rebleeding within 30 days (10% vs. 18%) or all-cause mortality (4% vs. 8%). There also was no difference between groups for the remaining study outcomes.
“This study showed that the routine use of OTSC as primary hemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding. However, there may be a role of OTSC in expert hands where OTSC can be successfully applied,” Chan and colleagues concluded. “It also highlighted that there is a learning curve to the use of OTSC and that salvage after a misplaced OTSC could be challenging.”
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