Bentonite hemostatic powder noninferior to standard care for GI bleeding

In a single-blind randomized controlled trial, bleeding was controlled within 30 days in 90.1% of adults with acute nonvariceal bleeding on upper GI endoscopy assigned to receive TC-325 versus 81.4% of those assigned to standard treatment.

Bentonite hemostatic powder TC-325 is noninferior to standard care as a single endoscopic treatment for acute nonvariceal upper GI bleeding, a recent study found.

Researchers performed a single-blind randomized controlled trial at three university hospitals in Singapore, Thailand, and Hong Kong to compare TC-325 with standard endoscopic hemostatic treatments to control active bleeding from nonvariceal upper GI causes. Patients with acute bleeding from a nonvariceal cause on upper GI endoscopy were randomly assigned to receive TC-325 (n=111) or standard hemostatic treatment (n=113). Control of bleeding within 30 days was the primary outcome, while other outcomes included failure to control bleeding during index endoscopy, recurrent bleeding after initial hemostasis, need for additional interventions, blood transfusion, hospitalization, and death. If patients' bleeding could not be controlled with the assigned treatment, endoscopists were permitted to cross over to the other treatment. The study results were published Dec. 7 by Annals of Internal Medicine.

Of the 224 patients enrolled in the study, 136 (60.7%) had gastroduodenal ulcers, 33 (14.7%) had tumors, and 55 (24.6%) had other causes of bleeding. Within 30 days, bleeding was controlled in 100 of 111 patients (90.1%) in the TC-325 group and 92 of 113 patients (81.4%) in the standard treatment group (risk difference, 8.7 percentage points). Fewer failures of hemostasis during index endoscopy were seen with TC-325 versus standard treatment (3 [2.7%] vs. 11 [9.7%]; odds ratio, 0.26 [95% CI, 0.07 to 0.95]). Rates of recurrent bleeding within 30 days (8.1% vs. 8.8%) and need for further interventions (further endoscopic treatment, 7.2% vs. 8.8%; angiography, 1.8% vs. 3.5%; surgery, 0.9% vs. 0%) did not differ between groups. Fourteen patients died in each group (12.6% vs. 12.4%).

The authors noted that clinicians were not blinded to treatment group and that it was difficult to define failure with standard endoscopic hemostatic treatment, among other limitations. They concluded that TC-325 is not inferior to standard treatment for endoscopic control of nonvariceal upper GI bleeding. It may be used as a first endoscopic treatment for this indication and considered when other treatments have failed, the authors said. They called for additional comparative studies, however, noting that their results may have been biased in favor of TC-325 due to overrepresentation of GI tumor bleeding in the TC-325 group and the higher rate of rebleeding in the standard treatment group.

An accompanying editorial agreed that the study has limitations but called its findings important and said it showed that TC-325 can be used alone in nonvariceal upper GI bleeding or as rescue therapy, but only in patients with actively bleeding lesions. The editorialists urged caution when choosing TC-325 alone in patients with bleeding ulcers and said it may be reasonable to perform a second-look endoscopy 16 to 24 hours after successful immediate hemostasis in these cases. Optimal management algorithms will be further informed by future research, the editorialists said.