HemosprayTM for Gastrointestinal Bleeding From Cancer

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    140
  • sponsor
    King Chulalongkorn Memorial Hospital
Updated on 26 April 2022

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: 140 in total

Duration of participation for each volunteer: 180 days

Details
Condition Gastrointestinal Bleeding From Malignancy
Treatment TC-325
Clinical Study IdentifierNCT03855904
SponsorKing Chulalongkorn Memorial Hospital
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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