Gastrointestinal Bleeding From MalignancyNCT03855904
HemosprayTM for Gastrointestinal Bleeding From Cancer
A study testing TC-325 in people with Gastrointestinal Bleeding From Malignancy, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding From Malignancy
- What is being tested?
- TC-325
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute upper or lower gastrointestinal bleeding
- Endoscopy shows actively bleeding at index endoscopy (spurting or oozing)
- Bleeding from malignancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- TC-325
- Keywords
- GI bleeding, Hemospray, TC-325, malignancy, tumor
- Medical subject headings
- Gastrointestinal Hemorrhage, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-325Device
Also called HemosprayTM
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.
| Study group | Role | What they receive |
|---|---|---|
| TC-325 | Experimental | 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. Receives: Device: TC-325 |
| Traditional treatment (Control group) | Active comparator | 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. Receives: Device: TC-325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate
Rebleeding rate
Measured: 30 days
Secondary outcomes (1)
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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Jun 2019
- Primary completion31 Aug 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Bleeding From MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
- Investigators
- Rapat Pittayanon, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855904
- Sponsor's protocol ID
- RP014
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not share individual participant data to others.
Publications
Pittayanon R, Khongka W, Linlawan S, Thungsuk R, Aumkaew S, Teeratorn N, Maytapa J, Kimtrakool S, Pakvisal P, Kongtub N, Rerknimitr R, Barkun A. Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial. Gastroenterology. 2023 Sep;165(3):762-772.e2. doi: 10.1053/j.gastro.2023.05.042. Epub 2023 Jun 3.
PubMed 37277078
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hemostatic Powder TC-325 Versus Standard Endoscopic Treatment for Gastrointestinal Bleeding From Malignancy; a Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT03855904
- Acronym / sponsor ID
- RP014
- Keywords
- GI bleeding, Hemospray, TC-325, malignancy, tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| TC-325 | Experimental | Device: TC-325The 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) | Active comparator | Device: TC-325Control 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute upper or lower gastrointestinal bleeding
- Endoscopy shows actively bleeding at index endoscopy (spurting or oozing)
- Bleeding from malignancy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-325Also: HemosprayTMTC-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. | Device | TC-325, Traditional treatment (Control group) |
Primary outcome
To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate
Time frame: 30 days
Rebleeding rate
1 secondary outcome
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
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 37277078Pittayanon R, Khongka W, Linlawan S, Thungsuk R, Aumkaew S, Teeratorn N, Maytapa J, Kimtrakool S, Pakvisal P, Kongtub N, Rerknimitr R, Barkun A. Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial. Gastroenterology. 2023 Sep;165(3):762-772.e2. doi: 10.1053/j.gastro.2023.05.042. Epub 2023 Jun 3.
- Individual participant dataSharing planned: No. We will not share individual participant data to others.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rapat Pittayanon, MD principal investigator
King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC-325 in people with Gastrointestinal Bleeding From Malignancy, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of TC-325 in preventing 30-day rebleeding following the index malignant hemorrhage: Rebleeding rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.