Tc-325 effective for immediate GI tumor bleeding

The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.

The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.

“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.

The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.

The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.

Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.

An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).

Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.

Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.

Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.

The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.

SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.

The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.

The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.

“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.

The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.

The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.

Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.

An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).

Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.

Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.

Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.

The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.

SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.

The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.

The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.

“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.

The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.

The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.

Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.

An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).

Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.

Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.

Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.

The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.

SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.