Clinical trial · Interventional
HemosprayTM for Gastrointestinal Bleeding From Cancer
The Efficacy of Hemostatic Powder TC-325 Versus Standard Endoscopic Treatment for Gastrointestinal Bleeding From Malignancy; a Multi-center Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Title: The efficacy of hemostatic powder TC-325 versus standard endoscopic treatment for gastrointestinal bleeding from malignancy; a multi-center randomized trial Background: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. It has a trend to be an effective hemostasis method for active GI bleeding from tumor, however, in view of the lack of RCTs and large-scale studies, the efficacy of TC-325 is still inconclusive. Objective: To evaluate the efficacy of TC325 in endoscopic hemostasis treatment for malignant gastrointestinal hemorrhage.The 24-hour, 72-hour, 30-day, 90-day and 180-day rebleeding rate were assessed as the outcomes of treatment as well as 6-month mortality. Study design: Single-blinded, multi-center, randomized-control trial study The intervention (experimental) arm: TC-325 alone (define failure if continued bleeding despite application of 1 syringes) The control arm: Standard of (traditional) endoscopic treatments \*\* Crossover is possible. Inclusion criteria: Patients with acute upper or lower GIB from a lesion that is actively bleeding at index endoscopy (spurting or oozing) and is suspected to be malignant or diagnosed as malignancy from previous tissue diagnosis. Exclusion criteria: Patients less than 18 years old, previously included in the trial, ECOG score 3 or 4, pregnancy/lactation, and/or bleeding from GI sources suspected of not being malignant. If an endoscopist is unsure of the malignant likelihood of the lesion, he/she will not be enrolled. Sample size: 112 in total Duration of participation for each volunteer: 180 days
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Bleeding From Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC-325 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TC-325
- description
- The intervention (experimental) arm patients are treated initially with TC-325 alone. Treatment failure for TC-325 is defined as endoscopists cannot achieve hemostasis with 1 syringe (20gm) of TC-325.
- interventionNames
- Device: TC-325
- type
- ACTIVE_COMPARATOR
- label
- Traditional treatment (Control group)
- description
- Control group patients initially receive usual standard of (traditional) endoscopic treatment (SET) as defined by injection therapy with another modality or sole/combination use of thermal or mechanical modalities. Crossovers to either treatment arm are permitted if immediate haemostasis does not achieved with standard endoscopic or TC-325 application.Treatment failure of SET is defined as endoscopists cannot achieve hemostasis by selected SET.
- interventionNames
- Device: TC-325
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Acute upper or lower gastrointestinal bleeding * Endoscopy shows actively bleeding at index endoscopy (spurting or oozing) * Bleeding from malignancy Exclusion Criteria: * Less than 18 years old * Previously included in the trial * Eastern Cooperative Oncology Group (ECOG) score 3 or 4 * Pregnancy/lactation * Bleeding from GI sources suspected of not being malignant
References
Publications (1)
- DERIVEDPittayanon R, Khongka W, Linlawan S, Thungsuk R, Aumkaew S, Teeratorn N, Maytapa J, Kimtrakool S, Pakvisal P, Kongtub N, Rerknimitr R, Barkun A. Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial. Gastroenterology. 2023 Sep;165(3):762-772.e2. doi: 10.1053/j.gastro.2023.05.042. Epub 2023 Jun 3. PMID 37277078