Efficacy of the Over-The-Scope Clip Device in the Management of Acute Gastroduodenal Artery Territory Bleeding From Duodenal Ulcers: A Single-Center Experience

Abstract

Introduction: The over-the-scope clip (OTSC’) is a novel device for the management of acute bleeding originating from the gastroduodenal artery (GDA) territory. The compression force and volume of tissue captured are greater with OTSC relative to standard hemoclips. We compared the outcomes between OTSC® and standard hemoclips in the management of acute duodenal ulcer bleeding. Methods: We reviewed the electronic medical records of all patients evaluated in our tertiary referral center for acute duodenal ulcer bleeding between January 2005 and May 2014. Data were abstracted for demographic, comorbid conditions, and important clinical parameters such as anticoagulation status, INR, medication history and information on bleeding disorders and platelet dysfunction, outcomes related to hemostasis, re-bleeding, and re-intervention rates, number of clips placed, procedural adverse events, and cost-effectiveness of the procedure. Means and proportions between the 2 groups were compared. Results: A total of 828 patients had endoscopically confirmed acute duodenal source of bleeding. Of these, 211 patients underwent mechanical hemostasis as the primary treatment modality. Since 2008, in 25 patients (17 men), the source of bleeding was in the gastro duodenal artery territory, and this was treated with OTSC®. We identified 45 (35 men) age, location, and comorbidity matched controls between 2005 and 2008 who were treated with hemoclips. The rate of presumed re-bleeding requiring repeat endoscopy in OTSC patients was 32% compared to 33% in the hemoclip treated group (p=0.91). However, the re-intervention rate was 40% in the hemoclip group as compared to 28% in the OTSC® group (p=0.02). The average cost related to OTSC use was $511 +/- 225, as compared to $807 +/- 538 (p=0.01) related to hemoclip use. This can be attributed to the total number of clips utilized in patients undergoing hemoclip placement (mean: 3 SD: 2) as compared to patients treated with OTSC (mean: 1 SD: 0.3). The mean INR was 1.3 and there were no treatment-related adverse events in either of the groups. Conclusion: Patients who underwent OTSC management for acute GDA territory duodenal ulcer bleeding demonstrated a statistically significant reduction in the cost of clipping and required fewer re-interventions during follow-up as compared to patients who underwent hemoclip placement. A randomized controlled trial is recommended to confirm these findings.