SAN ANTONIO – Use of a large over-the-scope hemoclip for initial endoscopic treatment of severe nonvariceal upper gastrointestinal bleeding resulted in a markedly lower 30-day rebleeding rate compared with standard endoscopic hemostasis in the first-ever randomized prospective clinical trial addressing the issue, Dennis M. Jensen, MD, reported at the annual meeting of the American College of Gastroenterology.
The over-the-scope clip also resulted in significantly fewer complications and cut the red blood cell transfusion rate in half, added Dr. Jensen, professor of medicine at the University of California, Los Angeles.
“The results appear to relate to the clip’s superior ability to obliterate critical arterial blood flow underneath the stigmata of hemorrhage and thereby reduce lesion rebleeding,” according to Dr. Jensen.
However, he emphasized a couple of caveats regarding this highly effective intervention.
First, it’s best reserved for patients with major stigmata of hemorrhage: that is, active arterial bleeding, a nonbleeding visible vessel, and/or adherent clot. That’s where all the benefit lies. Study participants with minor stigmata of hemorrhage – mere oozing bleeding or flat spots with arterial flow by Doppler – did just fine with standard endoscopic hemostasis, and in that setting the over-the-scope clip offered no additional benefit.
Second, there’s a significant learning curve involved in successful use of the clip.
“If someone’s going to be using this they have to get additional training. There’s a lot of tricks to using this,” the gastroenterologist cautioned.
The two-center prospective trial included 49 patients with severe nonvariceal upper GI bleeding who were randomized double-blind to the over-the-scope clip or standard hemostasis with hemoclips and/or application of a multipolar probe with epinephrine pre-injection as initial therapy. The severe bleeding was due to peptic ulcers in 40 patients and Dieulafoy’s lesions in the rest. All participants received high-dose proton pump inhibitor therapy after randomization.
The primary endpoint was clinically significant rebleeding within 30 days following initial therapy. This occurred in 7 of 25 patients (28%) on standard treatment and in 1 of 24 (4%) treated with the over-the-scope clip. This translated to an 85% relative risk reduction, with an impressive low number-needed-to-treat of 4.2.
Among the 35 patients with major stigmata of hemorrhage, the rebleeding rate was 35% in the over-the-scope clip group, compared with 6.3% with standard therapy, with a number-needed-to-treat of 3.5.
All four severe complications – a stroke, aspiration pneumonia, a case of severe heart failure, and a bleeding ischemic ulcer secondary to angiographic embolization – occurred in the standard therapy group. Patients in that group also averaged a 1.3-day-longer hospital length of stay and 2.8 more days in the ICU; however, those trends didn’t achieve statistical significance because of the small study size.
One audience member leapt to his feet to declare: “This is the study we’ve all been waiting for.” He pressed Dr. Jensen for technical details about the procedure.
Dr. Jensen explained that the large clip goes over an 11-mm-diameter endoscope with a 3-mm hood and no teeth. But he cautioned that some gastroenterologists in a busy community practice may find the procedure too time- and labor-intensive for their liking.
“It really takes two people to treat a duodenal ulcer. Somebody has to push quite firmly and suction very hard as you try to deploy this. By suctioning hard, the clip will burrow in so long as it’s centered on the stigmata of hemorrhage; that’s really key,” according to Dr. Jensen.
The procedure takes longer than standard endoscopic hemostasis because the over-the-scope clip limits visualization. So the patient must be scoped twice: the first time with a clipless diagnostic endoscope, so the operator can get his or her bearings; then that scope needs to be taken out, the patient is reintubated, and the over-the-scope clip is brought to bear.
“You shouldn’t just grab this off the shelf and try to use it in an emergency. You’ll really have problems. People have to be taught with porcine models and they need to review the stigmata,” Dr. Jensen said.
He reported having no financial conflicts regarding this study, conducted free of commercial support.
SOURCE: Jensen DM. ACG 2019, Abstract 8.