Bleeding After GI EndoscopyNCT07540026
Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial
A study testing 3g of sucralfate powder and 1.5g of tranexamic acid powder and Standard Treatment in people with Bleeding After GI Endoscopy, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Background Gastrointestinal bleeding is a common disease among the population in Taiwan, with gastrointestinal tumor bleeding accounting for 3-5% of cases. The pathophysiology of gastrointestinal tumor bleeding is unique, involving fragile surface mucosa, abnormal vascular proliferation, and malformation, making… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding After GI Endoscopy
- What is being tested?
- 3g of sucralfate powder and 1.5g of tranexamic acid powder and Standard Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patients aged ≥ 18 years who accept endoscopy for upper GI tumor bleeding
Who cannot join
- patients with no need for endoscopic hemostasis, allergy to sucralfate, tranexamic acid, pregnancy, and patients with hollow organ perforation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Not Required For This Country, 704
Hsueh-Chien Chiang, MD, 8862353535 ext. 9118, scion456scion@gmail.com
About this study
Background Gastrointestinal bleeding is a common disease among the population in Taiwan, with gastrointestinal tumor bleeding accounting for 3-5% of cases. The pathophysiology of gastrointestinal tumor bleeding is unique, involving fragile surface mucosa, abnormal vascular proliferation, and malformation, making endoscopic hemostasis challenging. Conventional endoscopic hemostasis methods such as hemostatic injections, clips, or thermal coagulation have suboptimal success rates below 80%, with recurrence rates exceeding 50%. Recent clinical trials have demonstrated that hemostatic powder spraying effectively enhances hemostasis for gastrointestinal ulcers and reduces recurrence rates. Our previous research repurposed tranexamic acid in a powder form to enhance hemostasis for peptic ulcer and applied sucralfate powder to prevent postpolypectomy wound bleeding.
Study aim Our research team combines previous experience by using tranexamic acid and sucralfate drug powders to spray onto bleeding gastrointestinal tumors to achieve hemostatic effects. Additionally, tumor-derived exosomes are associated with tumor angiogenesis and growth, so we hypothesize that gastrointestinal tumor bleeding may be linked to VEGF and miR-21 expression within gastrointestinal tumor exosomes.
Study method This study is a clinical randomized controlled trial conducted at National Cheng Kung University Hospital. We will recruit 60 patients with gastrointestinal tumor bleeding undergoing endoscopic hemostasis. Patients in the experimental treatment group will receive additional topical administration of 1.5 g of tranexamic acid and 3 g of sucralfate drug powder. Immediate hemostasis and 30-day bleeding recurrence will be observed. Enrolled patients will also provide blood and tumor specimens for exosome analysis, evaluating the predictive effect of extracted tumor exosomes' VEGF and miR-21 on bleeding risk. This study will explore the association between specific tumor exosome expression levels and bleeding, serving as a basis for bleeding risk assessment and innovative therapies.
Read the detailed description
Upper gastrointestinal (GI) cancer bleeding is a challenging scenario in clinical practice, including esophageal cancer, gastric cancer, and duodenal cancer. Upper GI cancer bleeds because the growing tumor erodes into the gastrointestinal lining and blood vessels, creating ulcers or damaging capillaries. Certain risk factors contribute to upper GI tumor bleeding, including advanced tumor stage, male gender, older age, usage of certain medications (NSAIDs, anticoagulants, antiplatelets), and comorbidities like thrombocytopenia, coagulopathy, and chronic kidney disease.
Furthermore, angiogenesis in upper GI tumors increased the fragility of new tumor blood vessels, leading to slow oozing or severe hemorrhage. Upper GI cancer exosomes play a significant role in gastric cancer progression, influencing metastasis, drug resistance, and the tumor microenvironment. Exosomes contain and transport a wide range of DNA, mRNA, and miRNA molecules. Tumor-derived exosomes carry pro-angiogenic factors like vascular endothelial growth factor (VEGF) and miR-21, enhancing vessel permeability and clot instability in bleeding sites. In tumors, VEGF drives pathological angiogenesis, enabling tumor growth, invasion, and metastasis by forming leaky vessels. VEGF is transported via exosomes, leading to GI tumor bleeding risks. High serum VEGF also correlates with poor prognosis in gastric cancers. MiR-21 acts as an oncomiR in tumors, overexpressed across many cancers to promote proliferation, invasion, and metastasis by targeting tumor suppressor genes. In gastric cancers, elevated miR-21 correlates with advanced stages, angiogenesis, and bleeding risks through vessel instability.
Gastrointestinal tumor bleeding represents approximately 3-5% of all gastrointestinal bleeding cases, posing significant clinical challenges due to its unique pathophysiology and treatment complexity. The management of such bleeding is particularly difficult because malignant lesions have distinct characteristics compared to benign etiologies of bleeding. Gastrointestinal tumors often exhibit invasive growth patterns, causing disruption of the normal tissue architecture. They frequently develop multiple ulcerations on their surface, which serve as persistent bleeding sites. Additionally, local blood vessels within or adjacent to the tumor can be damaged or fragile, further complicating hemostasis.
In this situation, conventional endoscopic treatment, such as epinephrine injection, clipping, or heat coagulation for tumor bleeding, is challenging and less effective. Cohort studies have reported initial endoscopic hemostasis rates ranging from 31% to 86%, with rebleeding rates between 28% and 80% when using conventional endoscopic hemostatic methods. Hemostatic powder spray, introduced in clinical practice since around 2011, represents a novel endoscopic technique for managing active GI bleeding. The hemostatic powder is delivered through a spraying system under endoscopic visualization. When applied to the bleeding site, the hemostatic powder absorbs water and swells to create an adhesive barrier that covers the lesion and promotes hemostasis. Hemospray has been proven to achieve immediate hemostasis and decrease 30-day rebleeding rates in gastrointestinal tumor bleeding. However, current hemostatic powders on the market are expensive, and some case reports have indicated a risk of perforation in the gastrointestinal tract associated with Hemospray.
Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. Our recent study evaluating the effect of topical TXA powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect. This study involved 60 patients (30 in each group) with peptic ulcer bleeding. The application of topical TXA reduced the early treatment failure rate (6.7% vs 30%, P = 0.042).
Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. Our recent study proved the protective effect of topical sucralfate in preventing postpolypectomy bleeding. This study involved 160 patients (80 in each group) who underwent polypectomy. The application of topical sucralfate reduced the delayed bleeding rate (0% vs 6.4%, P = 0.029).
In combination with TXA powder in stabilizing the clotting, we expect the rebleeding event will be reduced. Our recent clinical trials applying the combination powder (TXA 1g + sucralfate 2g) in all upper GI bleeding have shown promising efficacy in immediate hemostasis. Between October 2024 and May 2025, a total of 60 patients with upper GI bleeding were enrolled. Among these patients, 54 patients (90%) had peptic ulcer bleeding with major SRH, 2 (3.3%) had tumor ulcer bleeding, 2 (3.3%) had Dieulafoy lesion, and 2 (3.3%) had angiodysplasia. Adding the combination powder demonstrated a significantly lower rebleeding rate (10.0% vs 36.7%, P=0.030). In this recent study, two patients with tumor bleeding were successfully treated with the drug powder after conventional therapy failed. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate can achieve immediate hemostasis and decrease 30-day rebleeding rates in gastrointestinal tumor bleeding.
Gastrointestinal tumor-derived exosomes transport pro-angiogenic factors like VEGF, which promote abnormal blood vessel formation, increasing permeability, and destabilizing clots at bleeding sites. This mechanism contributes to tumor bleeding by creating leaky, immature vessels prone to rupture. Current evidence shows uncertainty in whether serum or tumor exosome levels directly correlate with bleeding incidence. To investigate the relationship between upper GI tumor exosomes and tumor bleeding, this study will identify specific exosomes from upper GI tumors and measure their serum levels in cancer cohorts, correlating them with bleeding events for non-invasive hemorrhage risk prediction. Such insights enable proactive clinical monitoring and evaluation of recurrent bleeding. Targeting these pro-angiogenic exosomes via neutralizing antibodies or RNA interference offers a novel therapeutic method to stabilize vessels and mitigate gastric tumor bleeding
- Conditions
- Bleeding After GI Endoscopy
- Being tested
- 3g of sucralfate powder and 1.5g of tranexamic acid powder, Standard Treatment
- Keywords
- Gastric tumor, Tumor bleeding
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3g of sucralfate powder and 1.5g of tranexamic acid powderDrug
For patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. After endoscopic treatment, 5 minutes of observation time is needed for the immediate hemostasis confirmation. After endoscopic hemostasis, patients with upper gastrointestinal lesions received an intravenous 80-mg bolus of proton pump inhibitors followed by 8 mg/h continuously for at least 72 hours.
Epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | For patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. For patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. Receives: Drug: 3g of sucralfate powder and 1.5g of tranexamic acid powder |
| Standard group | Active comparator | For patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. Receives: Drug: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day rebleeding
Rebleeding was defined by any of the following criteria: (1) hematemesis or bloody nasogastric tube drainage occurring more than 6 hours after endoscopy; (2) melena recurring after initial normalization of stool color; (3) hematochezia occurring after normalization of stool color or melena; (4) development of tachycardia (heart rate ≥110 beats/min) or hypotension (systolic blood pressure ≤90 mm Hg) after at least 1 hour of stable vital signs without other identifiable cause; (5) a hemoglobin drop of ≥2 g/dL following two consecutive stable hemoglobin measurements; (6) tachycardia or hypotension persisting beyond 8 hours after the index endoscopy despite appropriate resuscitation, without alternative explanation, accompanied by ongoing melena or hematochezia; or (7) a persistent hemoglobin decline of >3 g/dL within 24 hours together with ongoing melena or hematochezia.
Measured: 30 days
immediate hemostasis
no evidence of further bleeding after 3 minutes of observation during the index endoscopy, with elapsed time measured by a stopwatch.
Measured: 3 minutes
Secondary outcomes (3)
rebleeding in need of TAE or surgery
rebleeding in need of TAE or surgery
Measured: 30 days
all cause mortality
all cause mortality
Measured: 30 days
hospitalization day
hospitalization day
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bleeding After GI EndoscopyStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- For patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. For patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. After endoscopic treatment, 5 minutes of observation time is needed for the immediate hemostasis confirmation. After endoscopic hemostasis, patients with upper gastrointestinal lesions received an intravenous 80-mg bolus of proton pump inhibitors followed by 8 mg/h continuously for at least 72 hours.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Chien Chiang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540026
- Sponsor's protocol ID
- A-BR-114-065
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After paper accept
Publications
Chiang HC, Chen PJ, Yang EH, Kuo TL, Hsieh MT, Kang JW, Cheng HC, Chang WL, Chen WY, Chiu HC, Lin MY, Hong TC, Chiang CM, Chen WC, Huang KK, Lu MH, Wu MH, Chen CY, Lin XZ, Chuang CH. Clinical Trial: Precise Administration of Sucralfate Powder in Prevention of Delayed Postpolypectomy Bleeding. A Randomized Controlled Trial. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00818. doi: 10.14309/ctg.0000000000000818.
PubMed 39836033Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24.
PubMed 37356632Ceci C, Atzori MG, Lacal PM, Graziani G. Role of VEGFs/VEGFR-1 Signaling and its Inhibition in Modulating Tumor Invasion: Experimental Evidence in Different Metastatic Cancer Models. Int J Mol Sci. 2020 Feb 18;21(4):1388. doi: 10.3390/ijms21041388.
PubMed 32085654Fu M, Gu J, Jiang P, Qian H, Xu W, Zhang X. Exosomes in gastric cancer: roles, mechanisms, and applications. Mol Cancer. 2019 Mar 15;18(1):41. doi: 10.1186/s12943-019-1001-7.
PubMed 30876419Wang M, Shu H, Cheng X, Xiao H, Jin Z, Yao N, Mao S, Zong Z. Exosome as a crucial communicator between tumor microenvironment and gastric cancer (Review). Int J Oncol. 2024 Mar;64(3):28. doi: 10.3892/ijo.2024.5616. Epub 2024 Jan 19.
PubMed 38240092Zheng Z, Zhai Y, Yan X, Wang Z, Zhang H, Xu R, Liu X, Cai J, Zhang Z, Shang Y, Zhang J, Yin J. Functions and Clinical Applications of Exosomes in Gastric Cancer. Int J Biol Sci. 2025 Feb 28;21(5):2330-2345. doi: 10.7150/ijbs.98087. eCollection 2025.
PubMed 40083701
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07540026
- Acronym / sponsor ID
- A-BR-114-065
- Conditions
- Bleeding After GI Endoscopy
- Keywords
- Gastric tumor, Tumor bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
Background Gastrointestinal bleeding is a common disease among the population in Taiwan, with gastrointestinal tumor bleeding accounting for 3-5% of cases. The pathophysiology of gastrointestinal tumor bleeding is unique, involving fragile surface mucosa, abnormal vascular proliferation, and malformation, making endoscopic hemostasis challenging. Conventional endoscopic hemostasis methods such as hemostatic injections, clips, or thermal coagulation have suboptimal success rates below 80%, with recurrence rates exceeding 50%. Recent clinical trials have demonstrated that hemostatic powder spraying effectively enhances hemostasis for gastrointestinal ulcers and reduces recurrence rates. Our previous research repurposed tranexamic acid in a powder form to enhance hemostasis for peptic ulcer and applied sucralfate powder to prevent postpolypectomy wound bleeding.
Study aim Our research team combines previous experience by using tranexamic acid and sucralfate drug powders to spray onto bleeding gastrointestinal tumors to achieve hemostatic effects. Additionally, tumor-derived exosomes are associated with tumor angiogenesis and growth, so we hypothesize that gastrointestinal tumor bleeding may be linked to VEGF and miR-21 expression within gastrointestinal tumor exosomes.
Study method This study is a clinical randomized controlled trial conducted at National Cheng Kung University Hospital. We will recruit 60 patients with gastrointestinal tumor bleeding undergoing endoscopic hemostasis. Patients in the experimental treatment group will receive additional topical administration of 1.5 g of tranexamic acid and 3 g of sucralfate drug powder. Immediate hemostasis and 30-day bleeding recurrence will be observed. Enrolled patients will also provide blood and tumor specimens for exosome analysis, evaluating the predictive effect of extracted tumor exosomes' VEGF and miR-21 on bleeding risk. This study will explore the association between specific tumor exosome expression levels and bleeding, serving as a basis for bleeding risk assessment and innovative therapies.
Detailed description
Upper gastrointestinal (GI) cancer bleeding is a challenging scenario in clinical practice, including esophageal cancer, gastric cancer, and duodenal cancer. Upper GI cancer bleeds because the growing tumor erodes into the gastrointestinal lining and blood vessels, creating ulcers or damaging capillaries. Certain risk factors contribute to upper GI tumor bleeding, including advanced tumor stage, male gender, older age, usage of certain medications (NSAIDs, anticoagulants, antiplatelets), and comorbidities like thrombocytopenia, coagulopathy, and chronic kidney disease.
Furthermore, angiogenesis in upper GI tumors increased the fragility of new tumor blood vessels, leading to slow oozing or severe hemorrhage. Upper GI cancer exosomes play a significant role in gastric cancer progression, influencing metastasis, drug resistance, and the tumor microenvironment. Exosomes contain and transport a wide range of DNA, mRNA, and miRNA molecules. Tumor-derived exosomes carry pro-angiogenic factors like vascular endothelial growth factor (VEGF) and miR-21, enhancing vessel permeability and clot instability in bleeding sites. In tumors, VEGF drives pathological angiogenesis, enabling tumor growth, invasion, and metastasis by forming leaky vessels. VEGF is transported via exosomes, leading to GI tumor bleeding risks. High serum VEGF also correlates with poor prognosis in gastric cancers. MiR-21 acts as an oncomiR in tumors, overexpressed across many cancers to promote proliferation, invasion, and metastasis by targeting tumor suppressor genes. In gastric cancers, elevated miR-21 correlates with advanced stages, angiogenesis, and bleeding risks through vessel instability.
Gastrointestinal tumor bleeding represents approximately 3-5% of all gastrointestinal bleeding cases, posing significant clinical challenges due to its unique pathophysiology and treatment complexity. The management of such bleeding is particularly difficult because malignant lesions have distinct characteristics compared to benign etiologies of bleeding. Gastrointestinal tumors often exhibit invasive growth patterns, causing disruption of the normal tissue architecture. They frequently develop multiple ulcerations on their surface, which serve as persistent bleeding sites. Additionally, local blood vessels within or adjacent to the tumor can be damaged or fragile, further complicating hemostasis.
In this situation, conventional endoscopic treatment, such as epinephrine injection, clipping, or heat coagulation for tumor bleeding, is challenging and less effective. Cohort studies have reported initial endoscopic hemostasis rates ranging from 31% to 86%, with rebleeding rates between 28% and 80% when using conventional endoscopic hemostatic methods. Hemostatic powder spray, introduced in clinical practice since around 2011, represents a novel endoscopic technique for managing active GI bleeding. The hemostatic powder is delivered through a spraying system under endoscopic visualization. When applied to the bleeding site, the hemostatic powder absorbs water and swells to create an adhesive barrier that covers the lesion and promotes hemostasis. Hemospray has been proven to achieve immediate hemostasis and decrease 30-day rebleeding rates in gastrointestinal tumor bleeding. However, current hemostatic powders on the market are expensive, and some case reports have indicated a risk of perforation in the gastrointestinal tract associated with Hemospray.
Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. Our recent study evaluating the effect of topical TXA powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect. This study involved 60 patients (30 in each group) with peptic ulcer bleeding. The application of topical TXA reduced the early treatment failure rate (6.7% vs 30%, P = 0.042).
Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. Our recent study proved the protective effect of topical sucralfate in preventing postpolypectomy bleeding. This study involved 160 patients (80 in each group) who underwent polypectomy. The application of topical sucralfate reduced the delayed bleeding rate (0% vs 6.4%, P = 0.029).
In combination with TXA powder in stabilizing the clotting, we expect the rebleeding event will be reduced. Our recent clinical trials applying the combination powder (TXA 1g + sucralfate 2g) in all upper GI bleeding have shown promising efficacy in immediate hemostasis. Between October 2024 and May 2025, a total of 60 patients with upper GI bleeding were enrolled. Among these patients, 54 patients (90%) had peptic ulcer bleeding with major SRH, 2 (3.3%) had tumor ulcer bleeding, 2 (3.3%) had Dieulafoy lesion, and 2 (3.3%) had angiodysplasia. Adding the combination powder demonstrated a significantly lower rebleeding rate (10.0% vs 36.7%, P=0.030). In this recent study, two patients with tumor bleeding were successfully treated with the drug powder after conventional therapy failed. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate can achieve immediate hemostasis and decrease 30-day rebleeding rates in gastrointestinal tumor bleeding.
Gastrointestinal tumor-derived exosomes transport pro-angiogenic factors like VEGF, which promote abnormal blood vessel formation, increasing permeability, and destabilizing clots at bleeding sites. This mechanism contributes to tumor bleeding by creating leaky, immature vessels prone to rupture. Current evidence shows uncertainty in whether serum or tumor exosome levels directly correlate with bleeding incidence. To investigate the relationship between upper GI tumor exosomes and tumor bleeding, this study will identify specific exosomes from upper GI tumors and measure their serum levels in cancer cohorts, correlating them with bleeding events for non-invasive hemorrhage risk prediction. Such insights enable proactive clinical monitoring and evaluation of recurrent bleeding. Targeting these pro-angiogenic exosomes via neutralizing antibodies or RNA interference offers a novel therapeutic method to stabilize vessels and mitigate gastric tumor bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. For patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. After endoscopic treatment, 5 minutes of observation time is needed for the immediate hemostasis confirmation. After endoscopic hemostasis, patients with upper gastrointestinal lesions received an intravenous 80-mg bolus of proton pump inhibitors followed by 8 mg/h continuously for at least 72 hours.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: 3g of sucralfate powder and 1.5g of tranexamic acid powderFor patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. For patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. |
| Standard group | Active comparator | Drug: Standard TreatmentFor patients in both the standard group and intervention group, epinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged ≥ 18 years who accept endoscopy for upper GI tumor bleeding
Key exclusion criteria (1 listed)
- patients with no need for endoscopic hemostasis, allergy to sucralfate, tranexamic acid, pregnancy, and patients with hollow organ perforation
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 |
|---|---|---|
| 3g of sucralfate powder and 1.5g of tranexamic acid powderFor patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. After endoscopic treatment, 5 minutes of observation time is needed for the immediate hemostasis confirmation. After endoscopic hemostasis, patients with upper gastrointestinal lesions received an intravenous 80-mg bolus of proton pump inhibitors followed by 8 mg/h continuously for at least 72 hours. | Drug | intervention group |
| Standard TreatmentEpinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding. | Drug | Standard group |
Primary outcome
30-day rebleeding
Time frame: 30 days
Rebleeding was defined by any of the following criteria: (1) hematemesis or bloody nasogastric tube drainage occurring more than 6 hours after endoscopy; (2) melena recurring after initial normalization of stool color; (3) hematochezia occurring after normalization of stool color or melena; (4) development of tachycardia (heart rate ≥110 beats/min) or hypotension (systolic blood pressure ≤90 mm Hg) after at least 1 hour of stable vital signs without other identifiable cause; (5) a hemoglobin drop of ≥2 g/dL following two consecutive stable hemoglobin measurements; (6) tachycardia or hypotension persisting beyond 8 hours after the index endoscopy despite appropriate resuscitation, without alternative explanation, accompanied by ongoing melena or hematochezia; or (7) a persistent hemoglobin decline of >3 g/dL within 24 hours together with ongoing melena or hematochezia.
immediate hemostasis
Time frame: 3 minutes
no evidence of further bleeding after 3 minutes of observation during the index endoscopy, with elapsed time measured by a stopwatch.
3 secondary outcomes
rebleeding in need of TAE or surgery
Time frame: 30 days
all cause mortality
Time frame: 30 days
hospitalization day
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 39836033Chiang HC, Chen PJ, Yang EH, Kuo TL, Hsieh MT, Kang JW, Cheng HC, Chang WL, Chen WY, Chiu HC, Lin MY, Hong TC, Chiang CM, Chen WC, Huang KK, Lu MH, Wu MH, Chen CY, Lin XZ, Chuang CH. Clinical Trial: Precise Administration of Sucralfate Powder in Prevention of Delayed Postpolypectomy Bleeding. A Randomized Controlled Trial. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00818. doi: 10.14309/ctg.0000000000000818.
- Results publication: PubMed 37356632Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24.
- Results publication: PubMed 32085654Ceci C, Atzori MG, Lacal PM, Graziani G. Role of VEGFs/VEGFR-1 Signaling and its Inhibition in Modulating Tumor Invasion: Experimental Evidence in Different Metastatic Cancer Models. Int J Mol Sci. 2020 Feb 18;21(4):1388. doi: 10.3390/ijms21041388.
- Results publication: PubMed 30876419Fu M, Gu J, Jiang P, Qian H, Xu W, Zhang X. Exosomes in gastric cancer: roles, mechanisms, and applications. Mol Cancer. 2019 Mar 15;18(1):41. doi: 10.1186/s12943-019-1001-7.
- Results publication: PubMed 38240092Wang M, Shu H, Cheng X, Xiao H, Jin Z, Yao N, Mao S, Zong Z. Exosome as a crucial communicator between tumor microenvironment and gastric cancer (Review). Int J Oncol. 2024 Mar;64(3):28. doi: 10.3892/ijo.2024.5616. Epub 2024 Jan 19.
- Results publication: PubMed 40083701Zheng Z, Zhai Y, Yan X, Wang Z, Zhang H, Xu R, Liu X, Cai J, Zhang Z, Shang Y, Zhang J, Yin J. Functions and Clinical Applications of Exosomes in Gastric Cancer. Int J Biol Sci. 2025 Feb 28;21(5):2330-2345. doi: 10.7150/ijbs.98087. eCollection 2025.
- Individual participant dataSharing planned: Yes. After paper accept
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3g of sucralfate powder and 1.5g of tranexamic acid powder and Standard Treatment in people with Bleeding After GI Endoscopy, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsueh-Chien Chiang, MD (8862353535 ext. 9118, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day rebleeding (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT07540026, which also lists 6 linked publications.
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 20 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.