Clinical trial · Interventional
Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer. Recently developed hemostatic powder \[Endo-Clot(TM)\] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility \& safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding at Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endo-Clot(TM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endo-Clot(TM)
- interventionNames
- Drug: Endo-Clot(TM)
Primary outcomes (1)
- measure
- Rebleeding rate
- timeFrame
- within 30 days
- description
- Proportion of patients who are experience rebleeding events after hemostasis within 30 days expected to be lower than 10 %. Definition rebleeding events 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.
Secondary outcomes (4)
- measure
- Success of bleeding control rate
- timeFrame
- within 2 weeks and 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 19 and less 80 yeas old * Gastric cancer was diagnosed with biopsy and/or computed tomography * Endoscopic hemostasis is needed upto GI hemorrhage * Endoscopic examination is available in 24hours * ECOG performance status(PS) \<2 Exclusion Criteria: * Double primary caner * Hypersensitivity of hemostatic power\[Endo-Clot(TM)\] * Variceal bleeding or benign gastric ulcer bleeding * Hemodynamically unstable with low systolic BP\<90mmHg and/or tachycardia PR\>120bpm * endoscopic hemostasis within 7 days before screening * Contraindication for endoscopic examination * Pregnant * Breast feeding * bleeding tendency with low platelet count \<50,000 /mm\^3 and/or INR\>2 * Bacterial infection with needs for antibiotics therapy * Unavailable to discontinue anti-coagulation agent for 3days * Vascular shunt * Cardiovascular and/or pulmonary diseases * Active hepatitis or severe liver diseases * Renal dysfunction * Bone marrow dysfunction * Neurologic deficit and/or psychotic feature * Unavailable informed consent
References
Publications (16)
- RESULTThrumurthy SG, Chaudry MA, Hochhauser D, Mughal M. The diagnosis and management of gastric cancer. BMJ. 2013 Nov 4;347:f6367. doi: 10.1136/bmj.f6367. No abstract available. PMID 24191271
- RESULTChaw CL, Niblock PG, Chaw CS, Adamson DJ. The role of palliative radiotherapy for haemostasis in unresectable gastric cancer: a single-institution experience. Ecancermedicalscience. 2014 Jan 10;8:384. doi: 10.3332/ecancer.2014.384. eCollection 2014. PMID 24482669
- RESULTLee HJ, Yang HK, Ahn YO. Gastric cancer in Korea. Gastric Cancer. 2002;5(3):177-82. doi: 10.1007/s101200200031. No abstract available. PMID 12378346
- RESULTIsobe Y, Nashimoto A, Akazawa K, Oda I, Hayashi K, Miyashiro I, Katai H, Tsujitani S, Kodera Y, Seto Y, Kaminishi M. Gastric cancer treatment in Japan: 2008 annual report of the JGCA nationwide registry. Gastric Cancer. 2011 Oct;14(4):301-16. doi: 10.1007/s10120-011-0085-6. Epub 2011 Sep 7. PMID 21894577
- RESULTLasithiotakis K, Antoniou SA, Antoniou GA, Kaklamanos I, Zoras O. Gastrectomy for stage IV gastric cancer. a systematic review and meta-analysis. Anticancer Res. 2014 May;34(5):2079-85. PMID 24778009
- RESULTRomera Barba E, Castaner Ramon-Llin J, Sanchez Perez A, Garcia Marcilla JA, Vazquez Rojas JL. Transcatheter arterial embolization in the management of acute bleeding from advanced gastric cancer. Cir Esp. 2014 Aug-Sep;92(7):492-4. doi: 10.1016/j.ciresp.2013.11.004. Epub 2013 Dec 27. No abstract available. English, Spanish. PMID 24378191
- RESULTSheibani S, Kim JJ, Chen B, Park S, Saberi B, Keyashian K, Buxbaum J, Laine L. Natural history of acute upper GI bleeding due to tumours: short-term success and long-term recurrence with or without endoscopic therapy. Aliment Pharmacol Ther. 2013 Jul;38(2):144-50. doi: 10.1111/apt.12347. Epub 2013 May 28.