Background and Aims
Endoscopic hemostatic techniques remain poorly effective for GI tumor bleeding. We
assessed Tc-325 (Hemospray, Cook Medical, Bloomington, Ind, USA) for this indication
and determined possible predictors of decreased recurrent bleeding and improved 6-month
survival in affected patients.
Methods
This retrospective study identified 99 patients with active malignant GI bleeding
(primary or metastatic) treated with Tc-325. Eleven patients were excluded because
of incomplete data. Data on patient characteristics and possible predictive factors
of early (72-hour) and delayed (7-, 14-, and 30-day) recurrent bleeding, as well as
6-month survival, were collected.
Results
Overall, 70.5% were male (age, 65 ± 14 years). Half had a high Eastern Cooperative
Oncology Group (ECOG) score (3 or 4). An upper GI cancer was found in 56.8%, and 72.7%
cancers were stage 4. Of those affected, 51.6% received at least 1 non-endoscopic
additional definitive hemostatic treatment after Tc-325. Immediate hemostasis with
Tc-325 was 97.7%, with recurrent bleeding noted in 15% (early) and 17% (delayed).
Six-month survival was 53.4%. On multivariable analysis, no predictive factor for
recurrent bleeding was identified, whereas ECOG score 0 to 2 (P = .001; hazard ratio [HR], 0.14; 95% confidence interval [CI], 0.04-0.47), cancer
stage 1 to 3 (P = .04; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostatic treatment
alone or in any combination with surgery, chemotherapy, radiotherapy, or radiologic
embolization (P = .002; HR, 0.24; 95% CI, 0.09-0.59) were significant prognosticators of 6-month
survival after adjusting for comorbidity, type of cancer bleeding, and presence of
a coagulopathy.
Conclusion
Before definitive therapy can be offered, Tc-325 provides effective initial hemostasis
of tumoral GI bleeding. Good performance status, non-end-stage cancer, and receiving
definite hemostatic treatment are independent predictors of 6-month survival. (Clinical
trial registration number: NCT03066700.)
Abbreviations:
CI (confidence interval), ECOG (Eastern Cooperative Oncology Group), HR (hazard ratio), INR (international normalized ratio), OR (odds ratio)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Gastrointestinal EndoscopyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- The burden of gastrointestinal and liver disease around the world.in: Talley N.J. Locke G.R. Moayyedi P. West J. Ford A.C. Saito Y.A. GI epidemiology: diseases and clinical methodology. 2nd ed. Wiley, Hoboken, NJ2014: 1-13
- Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) guideline.Endoscopy. 2015; 47: a1-a46
- Management of bleeding GI tumors.Gastrointest Endosc. 2010; 72: 817-824
- Management of patients with ulcer bleeding.Am J Gastroenterol. 2012; 107 (quiz 361): 345-360
- The role of endoscopy in the patient with lower GI bleeding.Gastrointest Endosc. 2014; 79: 875-885
- 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; 38: 144-150
- The efficacy of Hemospray in patients with upper gastrointestinal bleeding from tumor.Endosc Int Open. 2016; 4: E933-E936
- Endoscopic hemostatic devices.Gastrointest Endosc. 2009; 69: 987-996
- Aggressive endoscopy in critically ill patients with upper gastrointestinal bleeding and cancer.Gastrointest Endosc. 1974; 20: 152-153
- Outcome of endoscopic therapy for cancer bleeding in patients with unresectable gastric cancer.J Gastroenterol Hepatol. 2013; 28: 1489-1495
- Prognosis following upper gastrointestinal bleeding.PLoS One. 2012; 7: e49507
- Early clinical experience of the safety and effectiveness of Hemospray in achieving hemostasis in patients with acute peptic ulcer bleeding.Endoscopy. 2011; 43: 291-295
- A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).Endoscopy. 2016; 48: 1084-1095
- Use of the endoscopically applied hemostatic powder TC-325 in cancer-related upper GI hemorrhage: preliminary experience (with video).Gastrointest Endosc. 2012; 75: 1278-1281
- Methodology for randomized trials of patients with nonvariceal upper gastrointestinal bleeding: recommendations from an international consensus conference.Am J Gastroenterol. 2010; 105: 540-550
- Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors.Stat Med. 1996; 15: 361-387
- Hemospray for treatment of acute bleeding due to upper gastrointestinal tumours.Dig Liver Dis. 2017; 49: 514-517
- The successful endoscopic hemostasis factors in bleeding from advanced gastric cancer.Gastric Cancer. 2013; 16: 397-403
- Pharmacological manipulation of gastric juice: thrombelastographic assessment and implications for treatment of gastrointestinal haemorrhage.Gut. 1995; 36: 358-362
- Topical hemostatic agents: a systematic review with particular emphasis on endoscopic application in GI bleeding.Gastrointest Endosc. 2013; 77: 692-700
- Acute haemorrhage from gastric malignancy.Br J Surg. 1990; 77: 19-20
- Severe upper gastrointestinal tumor bleeding: endoscopic findings, treatment, and outcome.Endoscopy. 1996; 28: 244-248
- Endoscopic treatment of major bleeding from advanced gastroduodenal malignant lesions.Mayo Clin Proc. 1994; 69: 736-740
- Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer.Ann Oncol. 1997; 8: 163-168
- Clinical benefit of palliative radiation therapy in advanced gastric cancer.Acta Oncol. 2008; 47: 421-427
- Hemostatic powder TC-325 in the management of upper and lower gastrointestinal bleeding: a two-year experience at a single institution.Endoscopy. 2015; 47: 167-171
Article info
Publication history
Published online: November 20, 2017
Accepted:
November 9,
2017
Received:
September 12,
2017
Footnotes
DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
Identification
Copyright
© 2018 by the American Society for Gastrointestinal Endoscopy
