TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study. 
Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding.  However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT).  Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata.  This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers.  Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group.  TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer.  Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group.  One patient required angio-embolization therapy while three had successful conventional endotherapy.  Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related.  In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding.  Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers.  Larger trials are necessary for definitive results.