Clinical trial NCT03855904: HemosprayTM for Gastrointestinal Bleeding From Cancer
Official title: The Efficacy of Hemostatic Powder TC-325 Versus Standard Endoscopic Treatment for Gastrointestinal Bleeding From Malignancy; a Multi-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Bleeding From Malignancy
Keywords: GI bleeding
Hemospray
TC-325
malignancy
tumor
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the time of initial early endoscopy, following fulfillment of patient and bleeding lesion eligibility, central randomization is carried out in a 1:1 ratio, in blocks of 4. The confidential centralized random numbers allocation is obtained by using REDCap (https://www.project-redcap.org/), a web based platform available to all participating centres. An independent staff member maintained the randomization numbers in sealed opaque envelopes. After obtaining a written informed from an eligible patient, the gastroenterologists who were blinded to the sequence of treatment opened the next numbered sealed envelope with treatment allocation.Randomization is stratified by location of bleed (upper versus lower GI tract), considering the lack of comparative outcomes data in the literature, thus balancing known and unknown confounding more completely
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate
timeFrame: 30 days
Secondary outcomes:
measure: 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
timeFrame: 180 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Rapat Pittayanon, MD
role: PRINCIPAL_INVESTIGATOR
References: