TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

Abstract

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.

• Authors: Boon Eu Andrew Kwek, Tiing Leong Ang, Peng Lan Jeannie Ong, Yi Lyn Jessica Tan, Shih Wen Daphne Ang, Ngai Moh Law, Prem Harichander Thurairajah, Kwong Ming Fock
• Journal: Journal of digestive diseases (J Dig Dis) Vol. 18 Issue 6 Pg. 323-329 (Jun 2017) ISSN: 1751-2980 [Electronic] Australia
• PMID: 28485544 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Chemical References

• Hemostatics
• Minerals
• hemospray

Topics

• Adult
• Aged
• Aged, 80 and over
• Combined Modality Therapy
• Female
• Hemostasis, Endoscopic (methods)
• Hemostatics (administration & dosage)
• Humans
• Male
• Middle Aged
• Minerals (administration & dosage)
• Peptic Ulcer (therapy)
• Peptic Ulcer Hemorrhage (therapy)
• Pilot Projects
• Recurrence
• Treatment Outcome
• Young Adult