Gastrointestinal Bleeding From Malignancy Clinical Trial
Official title:
The Efficacy of Hemostatic Powder TC-325 Versus Standard Endoscopic Treatment for Gastrointestinal Bleeding From Malignancy; a Multi-center Randomized Trial
| Verified date | September 2022 |
| Source | King Chulalongkorn Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 112 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | August 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | King Chulalongkorn Memorial Hospital | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| King Chulalongkorn Memorial Hospital |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate | Rebleeding rate | 30 days | |
| Secondary | 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 | Morbidity and mortality rate | 180 days |