Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial

NCT07540026 | Recruiting

• 1 other identifier: A-BR-114-065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bleeding After GI Endoscopy

Keywords

Gastric tumor; Tumor bleeding

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 minutes

Secondary Outcomes (3)

• rebleeding in need of TAE or surgery

  30 days

• all cause mortality

  30 days

• hospitalization day

  30 days

Study Arms (2)

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.

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.

Drug: Standard Treatment

Interventions

3g of sucralfate powder and 1.5g of tranexamic acid powder DRUG

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.

intervention group

Standard Treatment DRUG

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.

Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥ 18 years who accept endoscopy for upper GI tumor bleeding

You may not qualify if:

• patients with no need for endoscopic hemostasis, allergy to sucralfate, tranexamic acid, pregnancy, and patients with hollow organ perforation

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Not Required For This Country, 704, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 39836033 RESULT

• Chiang 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.

  PMID: 37356632 RESULT

• Ceci 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.

  PMID: 32085654 RESULT

• Fu 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.

  PMID: 30876419 RESULT

• Wang 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.

  PMID: 38240092 RESULT

• Zheng 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.

  PMID: 40083701 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Hsueh-Chien Chiang, MD

CONTACT

8862353535; scion456scion@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After paper accept
• Access Criteria: Email PI for information

Locations

TW (1)