HemosprayTM for Gastrointestinal Bleeding From Cancer
- Conditions
- Gastrointestinal Bleeding From Malignancy
- Interventions
- Device: TC-325
- Registration Number
- NCT03855904
- Lead Sponsor
- King Chulalongkorn Memorial Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- Acute upper or lower gastrointestinal bleeding
- Endoscopy shows actively bleeding at index endoscopy (spurting or oozing)
- Bleeding from malignancy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TC-325 TC-325 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. Traditional treatment (Control group) TC-325 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.
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate 30 days Rebleeding rate
- Secondary Outcome Measures
Name Time Method 1. To evaluate the efficacy of TC-325 in immediate hemostasis and rebleeding at 24 hours, 72 hours, 90 days and 180 days following presentation at initial bleeding episode as well as 6-month survival rate 180 days Morbidity and mortality rate
Trial Locations
- Locations (1)
King Chulalongkorn Memorial Hospital
🇹đź‡Bangkok, Thailand