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TC‐325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high‐risk bleeding stigmata: A randomized pilot study
Author(s) -
Kwek Boon Eu Andrew,
Ang Tiing Leong,
Ong Peng Lan Jeannie,
Tan Yi Lyn Jessica,
Ang Shih Wen Daphne,
Law Ngai Moh,
Thurairajah Prem Harichander,
Fock Kwong Ming
Publication year - 2017
Publication title -
journal of digestive diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 51
eISSN - 1751-2980
pISSN - 1751-2972
DOI - 10.1111/1751-2980.12481
Subject(s) - medicine , stigmata , peptic , randomized controlled trial , gastroenterology , peptic ulcer , surgery , archaeology , history
OBJECTIVE 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. METHODS This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. RESULTS 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. CONCLUSIONS 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.