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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Bleeding From Malignancy
• Intervention / Treatment: Device: TC-325

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: TC-325; TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.; Other Names: HemosprayTM
Active Comparator: Traditional treatment (Control group); 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.	Device: TC-325; TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.; Other Names: HemosprayTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate	Rebleeding rate	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: GI bleeding; malignancy; tumor; Hemospray; TC-325
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Neoplasms; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: RP014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will not share individual participant data to others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes