Introduction
Upper gastrointestinal bleeding (UGIB) in patients with cancer is a challenging situation
since these patients usually present a poor clinical condition and endoscopic hemostasis
is difficult and only modestly effective. A 30-day mortality rate ranging from 10 %
to 45 % has been reported [1 ]
[2 ]
[3 ]
[4 ]. In a retrospective study conducted at our institution, patients with malignant
bleeding had a median survival of 20 days with a 30-day mortality rate of 44.9 % [1 ]. Moreover, rebleeding and mortality rates were not affected by endoscopic treatment.
Numerous endoscopic treatments have been described in small case series for hemostasis
of malignant bleeding, with initial success rates ranging from 63 % to 100 % and rebleeding
rates ranging from 30 % to 80 % [2 ]
[3 ]
[5 ]
[6 ]
[7 ]
[8 ]. Bleeding from malignant lesions is usually diffuse. In addition, the tumor surface
is friable, reducing the efficacy of clipping, injection and elastic banding, even
in the presence of focal bleeding.
In this sense, a thermal therapy like argon plasma coagulation (APC) is attractive,
since it can be applied over large surfaces. However, in a retrospective comparative
study conducted in our institution, we did not find any benefits in rebleeding and
mortality rates comparing APC vs non-treated patients [5 ].
Recently, TC-325 powder (Hemospray; Cook Medical, Winston-Salem, North Carolina,
United States), has emerged as a promising hemostatic therapy. Two recent meta-analysis
reported immediate hemostasis rates of 93 % to 97 % and rebleeding rates of 14.4 %
to 27 % [9 ]
[10 ]. The role of TC-325 powder in GI malignancy was tested in a pilot randomized study
(10 patients in each arm), achieving immediate hemostasis in 90 % of patients, 20 %
rebleeding (180 days) and 30-day mortality of 50% [4 ].
The aim of this study was to compare the efficacy of TC-325 powder versus best clinical
management in the treatment of malignant upper GI bleeding.
Patients and methods
This was a prospective randomized controlled trial conducted at the Cancer Institute
of the University of São Paulo (Instituto do Cancer do Estado de São Paulo – ICESP)
between August 2016 and February 2020 (when occurred a global recall of TC-325 hemostatic
powder). This study was approved by the local research ethics committee of our institution
(CAAE55377216.0.0000.0065) and was registered on ClinicalTrials.gov (NCT02820077).
All patients registered in our institution must have a confirmed diagnosis of cancer.
Patient eligibility
All patients with malignancy referred to the endoscopy unit (inpatient or outpatients)
with suspected UGIB were eligible to the study. Inclusion criteria were patients with
a known diagnosis of malignancy from any site; history of hematemesis, hematochezia
or melena in the last 48 hours and endoscopic confirmation of bleeding from neoplasia
(primary or metastatic) located in the upper gastrointestinal tract. Exclusion criteria
included bleeding from a non-malignant lesion; previous treatment by another endoscopic
method in the last 48 hours; hemoglobin drop without overt bleeding, neoplastic hemobilia
and patients under 18 years old. Written informed consent was obtained from patients
or a legal responsible before performance of the index endoscopic procedure.
Randomization
If bleeding from a malignant lesion was confirmed at the index endoscopy, patients
were randomized to either the TC-325 or control group. Randomization was performed
by brown concealed envelopes arranged by blocks during index endoscopy. In the control
group, endoscopic treatment was not mandatory. However, if the attending endoscopist
judged that a specific treatment could benefit the patient, standard endoscopic therapies
such as injection, clipping, argon plasm coagulation or others, could be applied.
In the TC-325 group, the hemostatic powder was the only endoscopic therapy delivered.
In the case of non-active tumor bleeding, but with tumor bleeding stigmata, endoscopic
washing of the tumor surface with water jet was performed in order to remove the clot
and reactivate bleeding or to induce brisk bleeding, so that TC-325 powder could adhere
to the tumor surface and promote coagulation. If the tumor bleeding was not reactivated,
the patient was excluded. Cross-over was not contemplated in this trial.
Clinical data as status of the primary tumor, symptoms of the bleeding episode, hemodynamic
signs, comorbidities, Eastern Cooperative Oncology Group (ECOG) status, antiplatelet
or anticoagulation drugs and laboratory exams, were collected. AIMS65 score was calculated
based on albumin level, international normalized ratio (INR), alteration in mental
status, systolic blood pressure and age.
All healthcare personal involved with the patient treatment were blinded to the allocation
group (except the endoscopist) in order to minimize bias of clinical management and
additional treatment. The information that the patient had been included in TC-325
protocol was included in the endoscopy report, without mention to the allocation group. The
indication of hemostatic radiotherapy was let to the discretion of the attending physicians
after the index endoscopy.
Definitions
Tumor bleeding was defined when active bleeding from a primary or metastatic malignant
lesion was seen, or when there was coffee grounds stasis in the stomach, associated
with bleeding stigmata in the tumor (visible vessel, clot attached to the lesion),
without any other lesion that could justify the hemorrhagic condition (eg. ulcer,
esophageal varices, angioectasia, etc).
Immediate hemostasis was defined when active bleeding was seen during endoscopy and
TC-325 powder achieved sustained hemostasis during an observation period of 3 minutes
after endoscopic intervention. Recurrent bleeding after the index endoscopy was defined
if any of the following clinical criteria was noted: new episode of hematemesis, new
episode of melena or hematochezia; exteriorization of red blood content from a nasogastric
tube; hemodynamic instability (tachycardia or hypotension); or recurrent need of red
blood cell package transfusion. In the case of rebleeding after TC-325, an alternative
hemostatic therapy could be applied.
Study outcomes
The primary outcome of this study was 30-day mortality rate and 30-day rebleeding
rate. Secondary outcomes were blood transfusion and length of hospital stay.
Clinical evaluation and follow-up
Patients were monitored by dedicated research assistants through regular consultation
of electronic medical charts and laboratory exams. In the case of early hospital discharge,
telephone contact was made, inquiring about clinical signs and symptoms that may suggest
rebleeding. All patients received omeprazole 40 mg daily for the entire follow-up
period (30 days). Patients were withdrawn from the study if it was not possible to
obtain their medical data or due to loss of follow-up.
Sample size calculation
The sample size was calculated based on our previous experience, in which a 30-day
mortality rate of 44 % was expected. Alpha was set to 0.05 and a study power of 80 %
was adopted. At the time of conception of this study, there were no studies with quality
data on the use of TC-325 hemostatic powder in malignant bleeding. Thus, we assumed
that a reduction of 30-day mortality from 44 % to 20 % would be considered clinically
relevant. Considering a dropout rate of 5 %, a total of 47 patients would be necessary
in each arm.
Statistical analysis
Descriptive analysis of quantitative data with normal distribution were expressed
using means and standard deviations. Categorical variables were expressed with frequency
and percentages. A normal distribution was verified using the Shapiro-Wilk test. Quantitative
variables were compared using Student t-test, and categorical variables using chi-square
or Fisher’s exact test. Univariable analysis adopted logistic regression to explore
significant correlations between predictive variables and outcomes. Variables with
P ≤ 0.1 were included in the multivariable analysis (Stepwise Backward Likelihood Ratio).
P ≤ 0.05 was considered statistically significant. Statistical modeling and tests were
performed with the SPSS software, version 21.0 (SPSS Statistics for Windows, Version
21.0, IBM Corp., Armonk, New York, United States).
Results
Enrollment began in August 2016 and the last patient was included in January 2020. From
1406 eligible patients, 62 consecutive patients with confirmed upper malignant GI
bleeding were randomized. Three patients were excluded because of incomplete data
(2) and loss of follow-up (1). Finally, 59 patients were included in the final analysis,
28 in the TC-325 group and 31 in the control group ([Fig. 1 ]).
Fig. 1 CONSORT flow diagram. From Schulz KF, Altman DG, Moher D , for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting
parallel group randomised trials. Ann Int Med 2010; 1: 100–107
Most patients were male (57.6 %) with a mean age of 58.7 years (range 32–86 years).
The predominant primary tumor was gastric cancer (42.4 %), followed by esophageal
cancer (10.2 %). The majority of patients had a “good” performance status (61 % ECOG
0, 1 or 2); antiplatelet or/and anticoagulant medications were used by eight patients
(13.6 %). The mean hemoglobin at admission was 7.62 g/dL (range 2.9–14.3), with a
mean INR of 1.28 (± 0.28). Complete patients’ characteristics are shown in [Table 1 ]. Baseline clinical characteristics and laboratorial findings were similar between
groups.
Table 1
Baseline clinical characteristics and laboratory findings.
Variables
Total
TC-325 group
Control group
P
N = 59 (%)
N = 28 (%)
N = 31 (%)
Gender
34 (57.6)
17 (60.7)
17 (54.8)
0.648
25 (42.4)
11 (39.3)
14 (45.2)
Mean age (years)
58.7 (14.1)
55 (15.3)
62.1 (12.1)
0.053
Origin
48 (81.4)
23 (82.1)
25 (80.6)
0.883
11 (18.6)
5 (17.9)
6 (19.4)
Primary tumor
0.647
6 (10.2)
3 (10.7)
3 (9.7)
3 (5.1)
2 (7.1)
1 (3.2)
25 (42.4)
11 (39.3)
14 (45.2)
4 (6.8)
1 (3.6)
3 (9.7)
4 (6.8)
2 (7.1)
2 (6.5)
3 (5.1)
1 (3.6)
2 (6.5)
3 (5.1)
2 (7.1)
1 (3.2)
1 (1.7)
1 (3.6)
0
1 (1.7)
1 (3.6)
0
2 (3.4)
0
2 (6.5)
3 (5.1)
2 (7.1)
1 (3.2)
2 (3.4)
0
2 (6.5)
1 (1.7)
1 (3.6)
0
1 (1.7)
1 (3.6)
0
ECOG score
39 (66.1)
18 (64.3)
21 (67.7)
0.779
20 (33.9)
10 (35.7)
10 (32.3)
Comorbidities
6 (10.2)
3 (10.7)
3 (9.7)
> 0.999
3 (5.1)
2 (7.1)
1 (3.2)
0.599
5 (8.5)
3 (10.7)
2 (6.5)
0.661
24 (40.7)
8 (28.6)
16 (51.6)
0.072
8 (13.6)
3 (10.7)
5 (16.1)
0.709
48 (81.4)
23 (82.1)
25 (80.6)
0.883
Symptoms at admission
31 (52.5)
17 (53.6)
14 (51.6)
0.880
28 (47.5)
13 (46.4)
15 (48.4)
7.62
7.77 (± 2.43)
7.81 (± 2.04)
0.948
1.28 (± 0.28)
1.29 (± 0.30)
1.25 (± 0.24)
0.523
AIMS65
28 (52.8)
14 (51.9)
14 (53.8)
0.884
25 (47.2)
13 (48.1)
12 (46.2)
GE junction, gastroesophageal junction; ECOG, Eastern Cooperative Oncology Group;
INR, international normalized ratio.
Endoscopic findings and therapy
The most frequent location of tumor bleeding was the stomach (57.6 %), with a predominance
of bleeding from a primary neoplasm (67.8 %), followed by metastatic lesions (20.3 %)
and direct invasion (11.9 %). Active bleeding was identified in 41 patients (69.5 %),
22 (78.6 %) in the TC-325 group and 19 (61.3 %) in the control group (P = 0.15). Immediate hemostasis was achieved in all patients treated with TC-325. Six
patients (19.4%) in the control group received endoscopic therapy, including hemoclip
application (n = 2) and injection of adrenaline (n = 4), while no patients in the
TC-325 group required additional endoscopic therapy (P = 0.049; [Table 2 ]). There were no adverse events reported in either group.
Table 2
Endoscopic findings and procedure-related characteristics.
Variables
Total
TC-325 group
Control group
P
N = 59 (%)
N = 28 (%)
N = 31 (%)
Time to endoscopy
22 (37.3)
12 (42.9)
10 (32.3)
0.427
22 (37.3)
11 (39.3)
(35.5)
15 (25.4)
5 (17.9)
10 (32.3)
Location of tumor bleeding
8 (13.6)
5 (17.9)
3 (9.7)
0.607
34 (57.6)
16 (57.1)
18 (58.1)
17 (28.9)
7 (25.0)
10 (32.3)
Type of cancer
40 (67.8)
19 (67.9)
21 (67.7)
0.646
7 (11.9)
3 (10.7)
4 (12.9)
12 (20.3)
6 (21.4)
6 (19.4)
Active bleeding (AB)
41 (69.5)
22 (78.6)
19 (61.3)
0.150
6 (10.2)
6 (21.4)
NA
Signs of bleeding
24 (40.7)
11 (39.3)
13 (41.9)
0.366
14 (23.7)
4 (14.3)
10 (32.3)
2 (3.4)
1 (3.6)
1 (3.2)
9 (15.3)
5 (17.9)
4 (12.9)
10 (16.9)
7 (25.0)
3 (9.7)
Endoscopic therapy
28 (47.5)
28 (100.0)
0
0.049
2 (3.4)
0
2 (6.5)
4 (6.8)
0
4 (12.9)
NA, not applicable.
Eighteen patients did not have spontaneous active bleeding in the beginning of endoscopic
examination but presented tumor bleeding stigmata. Water jet irrigation was sufficient
to induce brisk bleeding in all these patients, so they were all included in the study.
Outcomes
There were no differences in 30-day mortality rates (TC-325 28.6 % vs. control 19.4 %,
P = 0.406). Recurrent bleeding at 30 days occurred in 9 (32.1 %) TC-325 patients and
6 (19.4 %) controls (P = 0.26). Of the nine patients in the TC-325 group who presented recurrent bleeding,
endoscopy was repeated in 6, with associated endoscopic therapy in one patient (APC).
Mean time to rebleeding was 8.2 (± 8.2) days in the TC-325 group and 4.5 (± 6.7) days
in the control group (P = 0.376). [Table 3 ] shows patient’s outcomes.
Table 3
Patient outcomes after randomization and endoscopy.
Variables
Total
TC-325 group
Control group
P
N = 59 (%)
N = 28 (%)
N = 31 (%)
Rebleeding rate (30 days)
15 (25.4)
9 (32.1)
6 (19.4)
0.26
Mean time to recurrent bleeding (days)
6.7 (± 7.6)
8.2 (± 8.2)
4.5 (± 6.7)
0.376
New endoscopic therapy
2 (3.4)
1 (3.6)
1 (3.2)
> 0.999
Additional treatment
3 (5.1)
1 (3.6)
2 (6.5)
0.615
2 (3.4)
0
2 (6.5)
0.493
28 (47.5)
12 (42.9)
16 (51.6)
0.501
30 (50.9)
12 (42.9)
18 (58.1)
0.243
45 (76.3)
20 (71.4)
25 (80.6)
0.41
15.0 (± 15.9)
17.4 (± 17.7)
12.8 (± 14.1)
0.277
14 (23.7)
8 (28.6)
6 (19.4)
0.406
Twenty patients (71.4 %) required red blood cell transfusions in the TC-325 group
compared to twenty-five (80.6 %) in the control group (P = 0.41; median 2 units/patient in each group). Additional non-endoscopic hemostatic
treatment was used similarly in both groups: surgery (3.6 % vs 6.5 %; P = 0.615), arteriography embolization (0 vs 6.5 %; P = 0.493) and radiotherapy (42.9 % vs 51.6 %; P = 0.501). Length of hospital stay after bleeding was also comparable between groups
(17.4 ± 17.7 days vs 12.8 ± 14.1 days; P = 0.277). [Table 3 ] shows patient’s outcomes after randomization and endoscopy.
Risk factors for 30-day rebleeding and mortality
On univariate analysis, age (P = 0.027), ECOG 3 or 4 (P = 0.009) and AIMS65 > 1 (P = 0.01) were associated to higher mortality rates ([Table 4 ]). All these factors were confirmed as risk factors for mortality on multivariate
analysis: age (OR 1.07; [confidence interval] CI 1.01–1.13; P = 0.032); ECOG (OR 7.89; CI 1.39–44.6; P = 0.019); AIMS65 (OR 6.04; CI 1.06–34.28; P = 0.042). Logistic regression analysis did not identify any risk factor for rebleeding
([Table 4 ]).
Table 4
Logistic regression analysis for risk factors for 30-day rebleeding and mortality.
30-day rebleeding
30-day mortality
Univariate analysis
Univariate analysis
Multivariate analysis
OR
CI (95 %)
P
OR
CI (95 %)
P
OR
CI (95 %)
P
Gender (male/female)
2.51
0.69 – 9.10
0.161
0.97
0.29 – 3.27
0.967
Age
1.02
0.97 – 1.06
0.420
1.06
1.00 – 1.12
0.027
1.07
1.01 – 1.13
0.032
Origin (inpatient/outpatient)
4.12
0.48 – 35.27
0.197
3.71
0.43 – 31.95
0.232
Primary tumor (gastric-GE junction/others)
0.67
0.2 – 2.19
0.504
0.53
0.15 – 1.83
0.318
ECOG (3–4/0–1-2)
3.05
0.91 – 10.24
0.072
5.56
1.53 – 20.16
0.009
7.89
1.39 – 44.6
0.019
History (melena/hematemesis)
0.96
0.29 – 3.10
0.943
0.53
0.15 – 1.83
0.318
AIMS65 score ( > 1/ ≤ 1)
0.97
0.29 – 3.22
0.963
6.54
1.56 – 27.48
0.010
6.04
1.06 – 34.28
0.042
Time to endoscopy (< 12 h/ > 24 h)
3.03
0.53 – 17.25
0.211
2.43
0.42 – 14.16
0.321
Time to endoscopy (12–24 h/ > 24 h)
2.44
0.42 – 14.16
0.321
2.43
0.42 – 14.16
0.321
Location of tumor bleeding (esophagus/duodenum)
1.44
0.24 – 8.46
0.687
2.80
0.42 – 18.69
0.288
Location of tumor bleeding (stomach/duodenum)
0.62
0.16 – 2.36
0.486
1.43
0.33 – 6.29
0.631
Primary metastasis (primary tumor/metastasis)
2.27
0.65 – 7.92
0.200
1.71
0.47 – 6.22
0.410
Active bleeding (yes/no)
0.84
0.24 – 2.94
0.783
3.31
0.65 – 16.67
0.147
Hemoglobin level
0.95
0.73 – 1.24
0.716
0.91
0.69 – 1.21
0.543
TC-325 therapy
1.97
0.6 – 6.51
0.264
1.66
0.49 – 5.59
0.408
OR, odds ratio; CI, confidence interval; GE junction, gastroesophageal junction; ECOG,
Eastern Cooperative Oncology Group.
Discussion
This randomized controlled trial reports on the largest published experience with
TC-325 in patients with malignant GI bleeding to date. Immediate hemostasis was achieved
in all patients treated with TC-325, confirming results of prior studies. Chen et
al. conducted a randomized pilot trial comparing TC-325 with a standard of care (SOC)
group, achieving immediate hemostasis in 90 % of patients treated with TC-325 versus
40 % in the SOC group (P = 0.057) [4 ]. A cohort of 41 patients with gastrointestinal tumor bleeding treated with TC-325
achieved immediate hemostasis in 97.5 % and 28 days rebleeding in 22.5 % [11 ]. A retrospective study including 12 patients with gastric malignant bleeding treated
with a similar hemostatic powder reported immediate hemostasis in all patients and
rebleeding in 16 % [12 ]. A systematic review and meta-analysis including 11 prospective studies and four
randomized trials found an immediate hemostasis rate of 93 % with TC-325 powder (95 %
CI 90.3–95 %, P < 0.001) [10 ]. For the subgroup of tumor-related bleeding, immediate hemostasis was achieved in
95.3 % (95 % CI 89.6–97.3 %; P < 0.001) and rebleeding rate was 21.9 % (95 % CI 13.9–32.7 %, P < 0.001) [10 ].
Despite the encouraging immediate results, TC-325 did not reduce the incidence of
30-day recurrent bleeding (TC-325 32.1 % vs control 19.4 %; P = 0.26). This contrasts with the results reported by Chen et al. [4 ] which reported a recurrence rate of 20 % in TC-325 group and 60 % in SOC group. However,
these results must be interpreted with caution, since 50 % of the patients allocated
to the SOC group crossed over to receive TC-325 after failed hemostasis attempt. Thus,
it is not known how many patients from the SOC group who presented recurrent bleeding
were treated with TC-325. Moreover, this was a pilot trial with low number of patients
and inferential analysis was not possible. Another non-randomized comparative study
(10 patients in each group) reported lower 14-day rebleeding rate in TC-325 group
although not statistically significant (10 % vs 30 %; P = 0.60) [13 ]. In a retrospective study with 99 patients with active malignant gastrointestinal
bleeding treated with TC-325, early recurrent bleeding occurred in 15 % and delayed
bleeding occurred in 17 % [14 ].
Also, TC-325 did not reduce 30-day mortality, which was as high as 28.6 % (versus
19.4 % on control group). This study confirms malignant gastrointestinal bleeding
as a pre-terminal or terminal event in the course of the patient’s disease. In the
study by Chen et al, 30-day mortality was 45 % and 180-day mortality was 80 % [4 ]. Pittayanon et al.[14 ] reported 6-month survival of 53.4 % in patients with active malignant GI bleeding
treated with TC-325, and the hemostatic powder was not predictive of rebleeding or
survival. Loftus et al. reported a median survival of 39 days after endoscopic therapy
for UGIB from tumors [2 ]. In two other studies conducted at our institution, 30-day mortality varied from
20.8 % to 44.9 %, and predictably, endoscopic treatment did not impact mortality rates
(43.9 % vs. 44.1 %, P = 0.677) [1 ]
[5 ].
As expected, poor ECOG status and AIMS65 score were predictors of mortality. ECOG
3 to 4 presented 7.89 OR (CI 1.39–44.6; P = 0.019) compared to ECOG 0, 1 and 2 on multivariate analysis and AIMS65 > 1 presented
6.04 OR (CI 1.06–34.28; P = 0.042) compared to AIMS65 score 0 and 1. Age was also a predictor of mortality.
Although the OR of 1.07 may suggest a weaker effect of age compared to ECOG and AIMS65,
it is important to understand that this effect is cumulative with aging, impacting
more significantly the older patients.
One may criticize that not all patients in this study presented active bleeding during
index endoscopy and that this could diminish TC-325 efficacy since it needs active
bleeding to absorb water, polymerize, activate and bind to the bleeding site. This
was considered during the conception of this study. One factor that motivate us to
try this therapy on these patients was the absence of effective endoscopy therapies
to treat them. In a prior study conducted at our institution, APC showed discouraging
results in reducing recurrent bleeding and mortality and, until now, we have no effective
alternative to offer to these patients [5 ]. Therefore, we opted to attempt to reactivate bleeding by applying water spray jet
in the tumor surface when evident malignant bleeding was diagnosed, so optimize TC-325
powder adherence to the tumor surface. In the present study, water spray jet proved
to be an efficient maneuver to reactive bleeding in all patients, allowing the application
of TC-325 powder.
The presumption that TC-325 powder could reduce the incidence of recurrent bleeding
is merely speculative, since the estimate dwelling time of TC-325 is around 12–24 h
[15 ]. However, although TC-325 did not reduce 30-day rebleeding rates in this study,
it presented excellent results of immediate hemostasis. This result may encourage
its use in cases of active bleeding, allowing better clinical compensation and planning
for additional therapy. In addition, treatment with TC-325 could be repeated in the
case of rebleeding, due to its high immediate hemostasis rate, ease of use and safety
profile. This hypothesis should be explored in future trials.
In this study, TC-325 did not reduce the need for additional treatment (surgery: P = 0.615; angiography: P = 0.493; radiotherapy: P = 0.501), the percentage of patients requiring a blood transfusion (71.4 % vs 80.6 %),
or the length of hospital stay (17.4 vs 12.8 days). A strength of this study was that
attending physicians caring for the patients after index endoscopy were blinded to
group allocation, which helped to reduce the indication bias of additional treatment,
blood transfusion and hospital stay.
This study had some limitations. First, this was a single-center study, conducted
in a tertiary care academic center with very debilitated patients manifesting advanced
disease. Selection bias may have influenced the results, which could limit the external
validity of our findings. Second, due to prolonged time to recruit patients and the
global recall of TC-325 in the beginning of 2020, the number of patients included
in this study was smaller than initial planned. We achieved 62 % of the planned cohort,
which impacted study power. The difficulty of recruiting patients had already being
experienced by other authors [4 ]. Moreover, even if the planned cohort had been achieved, the sample size might have
been too small to show an effect on rebleeding (a sample size of 124 patients would
be required to test a reduction from 30 % to 10 % on rebleeding rates). Nonetheless
it adds to a limited literature, especially in terms of controlled comparisons let
alone randomized trials, attempting to identify effective endoscopic methods in this
difficult patient population.
Conclusions
In conclusion, TC-325 was effective in achieving immediate hemostasis in patients
with malignant GI bleeding, but did not reduce 30-day mortality, 30-day rebleeding,
blood transfusion or length of hospital stay. Age, poor ECOG score, and AIMS65 score
> 1 were significant predictors of mortality.
