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Over-the-scope Clips Reduce Upper GI Rebleeding
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SAN ANTONIO — Patients with upper gastrointestinal bleeding treated with large, over-the-scope hemoclips experienced lower rates of rebleeding and severe complications, according to data presented at the American College of Gastroenterology Annual Meeting.
According to Dennis M. Jensen, MD, FACG, of the David Geffen School of Medicine at University of California, Los Angeles, recurrent bleeding from peptic ulcers and Dieulafoy’s lesions is common, and high-risk patients who receive standard treatment have a rebleeding rate of more than 26%.
“With visually guided, over-the-scope large clips, you can obliterate the blood flow underneath the stigmata, and most of the time, those patients don’t rebleed,” Jensen said in his presentation.
Researchers conducted a randomized controlled trial to compared over-the-scope clips (OTSC) with standard treatment (hemoclips and/or multipolar probe with epinephrine pre-injection). They randomly assigned patients who met clinical and emergency endoscopy criteria for peptic ulcers or Dieulafoy’ lesions (n = 49) to undergo standard treatment or OTSC. All patients received high dose proton pump inhibitors after randomization and were followed prospectively for 30 days.
Clinically significant rebleeding within 30 days served as the primary endpoint.
The proportion of patients with 30-day rebleeding in the OTSC group was 4.2% (1/24) compared with 28% (7/25) in the standard group (P = .022). The rebleed rate in the OTSC group was 85% lower than the standard group (RR = 0.149; 95% CI, 0.006-0.863).
The standard group also had higher rates of severe complications compared with the OTSC group (16% vs. 0%; P = .041).
Jensen said their findings appear to show the superiority of OTSC over standard treatment to reduce lesion rebleeding.
“These results primarily relate to the larger clip’s ability to obliterate underlying arterial blood flow, which is a significant risk factor for rebleeding,” he said. “It seems like only the patients with significant stigmata of hemorrhage benefited from this large clip, and it is unlikely that the lesser stigmata will because the standard treatment also worked very well.” – by Alex Young
Reference:
Jensen DM, et al. Abstract 8. Presented at: American College of Gastroenterology Annual Meeting; Oct. 25-30, 2019; San Antonio.
Disclosures: The authors report no relevant financial disclosures.
Perspective
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Sunguk Jang, MD
Dr. Jensen is a world-renowned expert in the area of endoscopic management of gastrointestinal bleeding, and his group has done extensive work in the area of endoscopic hemostasis. His new study on the effectiveness of over-the-scope hemoclips in managing non-variceal upper gastrointestinal bleeding (NVUGIB) provides new insight in the area of endoscopic hemostasis.
Despite significant advancement in the outcomes of endoscopic hemostasis, much frustration remains as the rate of rebleeding after a successful initial endoscopic hemostasis remains substantial. The rebleeding after endoscopic hemostasis appears to be irrespective of treatment modality: a mechanical hemostasis or thermo-ablative hemostatic method. The recent development of the over-the-scope clip (OTSC), which is a hemoclip with larger tissue “bite,” allows apposition of bigger tissue with stronger tamponading effect. Contrast to traditional hemoclips that are fed through the working channels of the endoscope, OTSC is mounted at the tip of the endoscope prior to its deployment.
The randomized controlled trial (RCT) design of Dr. Jensen’s study is significant as no previous RTC of such kind exists. In particular, the stratification of bleeding lesion based on endoscopic description of Forrest classification provides scientific and refined categorization of bleeding lesion, which is one of many strengths of the study.
The primary outcome of the study was the 30-day rebleeding rate and the study group found that using the over-the-scope clip dramatically reduced the incidence of rebleeding compared with the traditional endoscopic hemostatic methods. If validated, it is safe to say that OTSC will be considered as the “go-to” method of endoscopic hemostasis in selected circumstances.
Future directions should aim for a larger study. This was almost a pilot study with a relatively small number of study participants. Further, the cost of OTSC is much higher than traditional hemoclips and the cost analysis to justify its use should also be considered.
Finally, generalizability to everyday practice is an issue for a few reasons. First, Dr. Jensen’s group uses Doppler technology during endoscopy to identify the feeding vessel. The use of Doppler during endoscopy has not been adopted by the vast majority of GI practice, including our own institution. Also, technical proficiency in the use of OTSC should be examined. The over-the-scope clips approved in the United States – the neovascular clip or the padlock clip – do require more technical savviness than traditional hemoclips.
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