when used as primary treatment in patients with high-risk nonvariceal upper gastrointestinal lesions, shows a randomized controlled trial (RCT).
However, noted the investigators, writing in Annals of Internal Medicine, and physicians who wrote an accompanying editorial, reservations remain about first-line use of OTSCs, but mostly relate to method, technique, and cost.
“The absolute difference in the rate of further bleeding was 11.4 percentage points. We should however be cautious in our recommendation of using OTSC as first-line treatment,” wrote researchers who were led by James Y.W. Lau, MD, from Prince of Wales Hospital, Chinese University of Hong Kong.
“The primary use of OTSCs may find a role in the treatment of ulcers predicted to fail standard endoscopic treatment,” the authors wrote. However, they emphasized that, “We are not advocating routine primary use of OTSCs. These clips are costly, and a formal cost analysis is not available in the literature. The use of OTSCs involves scope withdrawal, mounting of the OTSCs, and scope reinsertion, which increase the procedure time. Endoscopists also require training before using OTSCs.”
Alan N. Barkun, MD, gastroenterologist and professor of medicine with McGill University, Montreal, who cowrote the editorial accompanying the research paper, said the study investigators were highly experienced surgeon-scientists, pointing out that, overall, first-line use of OTSC in this patient group improved patient outcomes.
“The main message here is that if you can position the clip properly, then it is likely to stay in place, better than standard approaches,” he said, adding that, “I support it fully for second-line use but there currently still exists uncertainty for routine first-line adoption in nonvariceal bleeding. Clinicians fail to position the clip properly in around 5% of patients which is higher than standard endoscopic approaches, and nobody has yet clearly defined the lesions that are difficult to clip with the OTSC.
“If you’re going to tell people to use it, then you need to tell them with which particular lesions OTSC works best as first-line approach,” he added.
Lesions of concern include upon leaving the stomach and entering the duodenum, and in passing from the first to the second stage of the duodenum. “These are tight areas, and these larger full-thickness bite OTSC may create pseudo-polyps, even possibly causing obstruction. Perforation is also a risk.” One of each of these complications were noted in this study.
The study included 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Of these, 97 patients received standard hemostatic treatment and 93 received OTSC. The primary endpoint of a 30-day probability of further bleeding was 14.6% in the standard treatment and 3.2% in the OTSC group (risk difference, 11.4 percentage points [95% confidence interval (CI), 3.3-20.0 percentage points]; P = .006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 in the standard treatment and OTSC groups, respectively. Thirty-day recurrent bleeding was 8 versus 2 in the standard treatment and OTSC groups, respectively. Eight patients in the standard treatment group needed further intervention compared with two in the OTSC group. Thirty-day mortality was four versus two, respectively.
“First-line OTSC has a role to play but whether it is the best approach is hard to say due to methodological limitations that were seen in this and earlier studies, however if you can position the clip properly it likely does well,” Dr. Barkun said.
Dr. Lau declares that he received honorarium for a lecture from OVESCO. Dr. Li has no disclosures. Dr. Barkun has no relevant disclosures.