TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial

Gastrointest Endosc. 2020 Feb;91(2):321-328.e1. doi: 10.1016/j.gie.2019.08.005. Epub 2019 Aug 19.

Abstract

Background and aims: TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding.

Methods: Adult patients presenting with acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality.

Results: A preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, age 67.2 ± 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P = .057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P = .170).

Conclusions: This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding. (Clinical trial registration number: NCT02135627.).

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Argon Plasma Coagulation
  • Electrocoagulation
  • Epinephrine / therapeutic use
  • Feasibility Studies
  • Female
  • Gastrointestinal Hemorrhage / etiology
  • Gastrointestinal Hemorrhage / therapy*
  • Gastrointestinal Neoplasms / complications*
  • Hemostasis, Endoscopic / methods*
  • Hemostatics / therapeutic use*
  • Humans
  • Injections, Intralesional
  • Light Coagulation
  • Male
  • Middle Aged
  • Minerals / therapeutic use*
  • Pilot Projects
  • Recurrence
  • Sclerosing Solutions / therapeutic use
  • Sodium Tetradecyl Sulfate / therapeutic use
  • Surgical Instruments
  • Vasoconstrictor Agents / therapeutic use

Substances

  • Hemostatics
  • Minerals
  • Sclerosing Solutions
  • Vasoconstrictor Agents
  • hemospray
  • Sodium Tetradecyl Sulfate
  • Epinephrine

Associated data

  • ClinicalTrials.gov/NCT02135627