REVIEW

CURRENT
OPINION New and emerging endoscopic therapies for
gastrointestinal bleeding
Ivo Boškoski, Pietro Familiari, and Guido Costamagna

Purpose of review
To highlight the most recent findings and results of new hemostatic agents for acute bleeding of the
gastrointestinal tract of common and less common cause published in the past 12 months.
Recent findings
New hemostatic agents have been tested and emerged as promising therapies for acute upper and lower
gastrointestinal bleeding. These are hemostatic sprays, stents for variceal tamponade and devices for
mechanical closure of the gut wall.
Summary
Some of these devices are capable to definitively stop a bleeding, others are used as adjuvant to other
techniques as bridge to other definitive treatments. All these devices have been tested recently; therefore,
more trials are needed to better establish their efficacy and safety.
Keywords
covered self-expandable metal stents, endoscopic hemostasis, hemostatic powders, over-the-scope clip

INTRODUCTION already known devices (used for other gastrointes-

In their recent editorial, Aslanian and Laine [1]
defined the ideal method of endoscopic hemostasis
as a method that would immediately stop active
bleeding, prevent rebleeding, require minimal train-
ing, be easy to apply, well tolerated, can be applied in
unlimited amounts, work in patients with coagulo-
pathies and be inexpensive. Science fiction or reality?
What we well know and all commonly use for
hemostasis of active bleeding of the gastrointestinal
tract include injection techniques (epinephrine,
thrombin/fibrin glue, sclerosants, tissue adhesives),
thermal devices (heater probe, argon plasma coagu-
lation, monopolar and bipolar electrocoagulation)
and mechanical devices (clips, ligation).
The efficacy of these techniques is good for most
common causes of bleeding. The interventional
radiologist and/or the surgeon can be of great help
in patients with refractory bleedings.
In the past years, there has been less evidence
available regarding the endoscopic treatment of
nonulcer causes of gastrointestinal bleedings, such
as neoplasms, postpolypectomy bleeding, erosions,
colitis and variceal bleedings, that are not suitable
for conventional therapy.
Recently, powder-based topical hemostatic
agents with similar mechanism of action and some
tinal problems) have been proposed in this field.
The purpose of this review is to highlight the
most recent findings and results of the use of new
hemostatic agents for acute bleedings of the gastro-
intestinal tract of common and less common cause
published in the past 12 months.
NEW AND EMERGING ENDOSCOPIC
THERAPIES
In the past few years, new agents and devices have
emerged as promising therapies for acute upper and
lower gastrointestinal bleeding. These are hemo-
static sprays, stents for variceal tamponade and
devices for mechanical closure of the wall of the gut.
Hemostatic sprays
A hemostatic device that works without contact, is
easy to apply, without the need for targeting, can
Digestive Endoscopy Unit, Catholic University of Rome, Rome, Italy
Correspondence to Ivo Boškoski, Digestive Endoscopy Unit, Catholic
University of Rome, Italy, Largo A. Gemelli 8, 00168 Rome, Italy.
Tel: +390630156580; e-mail: ivoboskoski@yahoo.com
Curr Opin Gastroenterol 2014, 30:439–443
DOI:10.1097/MOG.0000000000000105

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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
 Endoscopy
KEY POINTS
 New hemostatic powders are a promising hemostatic
tool that offers rapid hemostasis in selected cases.
 CSEMSs are good alternative as a bridge to therapy in
selected cases of variceal bleeding.
 OTSC is a novel device that can be chosen as first-line
therapy in critical bleeding or as adjuvant therapy
when other techniques have failed.
access lesions in difficult locations, can give
immediate hemostasis and can be used to treat wide
areas, appears to be a dream. However, the hemo-
static effect of plants and secret military hemostatic
powders has been already applied into practice.
Hemostatic sprays that are currently used in the
gastrointestinal tract are Ankaferd BloodStopper
(ABS) (Ankaferd Ilac Kozmetik AS, Istanbul, Turkey),
EndoClot polysaccharide hemostatic system (Endo-
Clot Plus Inc, Santa Clara, California, USA) and
Hemospray (Cook Medical, Winston-Salem, North
Carolina, USA).
Ankaferd BloodStopper
ABS is a derivate obtained from a mixture of five
herbs, used for centuries in Turkey as topical hemo-
static agent [2]. It is currently available in three
different pharmaceutical forms: ampoules, pads
and sprays. It is supposed that the hemostatic pro-
perties of ABS are related to its rapid induction of a
protein network in human plasma [3].
In-vitro ABS allows erythrocyte aggregation,
which integrates with the classic coagulation cascade
[2,3]. Furthermore, ABS stimulates the formation of
the encapsulated protein scaffold network [4]. How-
ever, the exact hemostatic mechanism of ABS is still
not fully understood [5].
ABS has been used as hemostatic agent in many
nonendoscopic sites of hemorrhage, including epi-
staxis, dental, head and neck, urological surgeries,
pediatric cases and bleeding disorders [6].
Endoscopically, ABS can be sprayed with a dis-
posable catheter (model PW-205L; Olympus Corp,
Tokyo, Japan) [7] directly on the site of bleeding.
The use of ABS was described either in upper and
lower gastrointestinal bleedings of various causes,
including polypectomies, Mallory-Weiss tears, Die-
ulafoy lesions and radiation colitis, excluding malig-
nancies [7–12]. Results of the published series were
promising, but the studies were published between
2008 and 2011. In the past 12 months, there were
only two case reports on the endoscopic use of ABS
in humans. One report describes two cases of topical
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use of ABS in diverticular bleeding, with immediate
&
hemostatic effect [13 ]. The other one describes a
case of gastroduodenal amyloidosis complicated
&
with gastrointestinal bleeding [14 ]. Also, in this
case, ABS was topically sprayed over the bleeding
site with good hemostatic effect.
The experience with ABS in many fields of non-
gastrointestinal bleeding is very large [6], but data
on its safety and efficacy in humans are lacking.
Therefore, large clinical trials are needed to establish
the effective benefits of ABS for upper and lower
gastrointestinal bleeding. At the time of writing of
this review, there was no documented approval on
the U.S. Food and Drug Administration website for
the use of ABS [15].
EndoClot polysaccharide hemostatic system
The EndoClot polysaccharide hemostatic system
(EndoClot Plus Inc, Santa Clara, California, USA)
is a recently developed hemostatic agent that is
briefly called EPI by the manufacturer [16]. This
product consists of absorbable modified powder
polymers derived from purified plant starch [17].
EPI is in a form of powder and can be directly
sprayed on the site of gastrointestinal bleeding
through the endoscope via a delivery catheter
&&
[18 ]. The EPI is sprayed under powder/gas mixing
chamber that is connected to the powder container
and an external gas source [18 ].
&&
EPI is a nonpyogenic, biocompatible compound
that absorbs water from serum concentrating plate-
lets, red blood cells and the proteins of coagulation,
thus accelerating the clotting cascade [16]. Also for
EPI, at the time of writing of this paper, there was no
documented approval on the U.S. Food and Drug
Administration website [15].
In the past 12 months, only Huang et al. [18 ]
&&
published a paper on the use of EPI for gastrointes-
tinal bleeding. The aim of this study was to observe
the hemostatic efficacy and safety to control and/or
prevent procedure-related bleeding of endoscopic
mucosal resection (EMR). The authors sprayed EPI
onto the mucosal defect created by EMR immedi-
ately after resection, whether or not there was post-
resection bleeding. They observed endoscopically
the sprayed region for 5 min. In case of bleeding
during observation, the EPI was sprayed again. A
second rebleeding episode was considered a treat-
ment failure. Eighty-two patients were enrolled and
a total of 181 lesions were resected by EMR (lesions
size from 0.5 to 4.0 cm). Of these, 20 lesions in 18
patients bleed immediately after EMR. In two
lesions, bleeding was controlled with hot biopsy
forceps. Rebleeding with positive fecal occult stool
test and colonoscopy recurred in three of the 18
patients that had immediate postprocedural
Volume 30  Number 5  September 2014
 Endoscopic therapies for gastrointestinal bleeding Boškoski et al.
bleeding. Delayed bleeding was observed in three
patients that did not have immediate postproce-
dural bleeding. No major adverse events of the
treatment during a 30-day follow-up were reported.
The authors concluded that EPI gives effective
hemostasis that controls and prevents EMR-related
bleeding.
These results are encouraging, and should be
motivation to perform further large trials to inves-
tigate the hemostatic effect of EPI in other types of
nonvariceal gastrointestinal bleeding.
Hemostatic agent TC-325
The most novel endoscopic hemostatic technology
is designated as TC-325, and its brand name is
Hemospray (Cook Medical Inc, Bloomington, Indi-
ana, USA).
Hemospray has not been approved by U.S. Food
and Drug Administration website at the time of
writing of this paper [15], but it has approval for
use in the endoscopic treatment of nonvariceal
gastrointestinal bleeding in Hong Kong, Europe
&&
and Canada [6,19 ].
Hemospray is a hemostatic powder that has no
human or animal proteins, neither contains bota-
nicals.
The mechanism of action is multimodal. It is
presumed that the hemostatic effect of Hemospray
is in its ability to quickly absorb water, and with this,
create a physical barrier, delivering a tamponade
effect at the bleeding site by concentrating blood
cells and clotting factors. Other mechanisms may
activate the clotting cascade along with aggregating
platelets, forming a fibrin plug [20–22].
Hemospray is composed of a CO2-pressurized
handheld canister (20 g) that contains the powder
and a spray catheter [23]. The powder should be
sprayed 1–2 cm from the bleeding site [23].
In 2013 Leblanc et al. [24] published a case series
on 17 patients (12 patients with postendoscopic
intervention bleeding and five patients with bleed-
ing due to malignancy of the gastrointestinal tract).
Outcomes of immediate bleeding cessation and
cases of rebleeding were evaluated.
The group of 12 patients underwent esophageal
(five) and duodenal (four) EMR, ampullary resection
(two) and biliary sphincterotomy (one). In eight
(66.7%) of these patients, Hemospray was used as
a first-line treatment, with immediate hemostasis.
In four patients (33.3%), Hemospray was success-
fully used as second-line treatment after standard
hemostatic techniques failed.
The five patients in the malignancy group had
active bleeding from the esophagus (two), stomach
(two) and pancreas (one). Hemospray was used as a
first-line treatment in four of the five patients with
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immediate hemostasis. In one patient, Hemospray
was successfully used as second-line treatment after
traditional hemostasis failed. In two patients,
rebleeding occurred after 1 week and was success-
fully stopped again with Hemospray. In one of these
patients rebleeding occurred after 30 days, and the
treatment was considered a failure.
The most recent paper regarding Hemospray
&&
was published in 2013 by Smith et al. [19 ]. This
involved 10 European centers in the Survey to Evalu-
ate the Application of Hemospray in the Luminal
tract survey. Hemospray was used as a single therapy
or as second-line therapy in combination with other
hemostatic modalities, on discretion of the endo-
scopist. In this survey, 63 patients with nonvariceal
upper gastrointestinal bleeding were treated with
Hemospray. Thirty patients had bleeding ulcers
and 33 had other causes of nonvariceal upper gastro-
intestinal bleeding. The authors treated 55 (87%)
patients with Hemospray as monotherapy. Of these,
primary hemostasis was achieved in 47 (85%), with
a rebleeding rate of 15% at 7 days. The authors
reported a primary hemostasis rate of 76% in
patients with bleeding ulcers. Hemospray was used
as second-line therapy in eight patients, after failure
of other endoscopic treatments.
We are waiting for further trials regarding the
efficacy and safety of Hemospray, even if this prod-
uct since the beginning has gained a big success in
its field of application.
Stents for variceal tamponade
Covered self-expandable metal stent (CSEMS) has
been used as salvage therapy for patients with esoph-
ageal variceal bleeding that is refractory to standard
endoscopic techniques and vasoactive drugs [25].
This technique was first described by Hubmann
et al. in 2006 [26]. As compared with balloon tam-
ponade, CSEMS placement allows oral nutrition,
does not impair patient mobility and can be left
in situ for 2 weeks as a bridge to definitive therapy
[26].
Fierz et al. [27] in 2013 published a case series of
seven patients with a total of nine variceal bleedings
treated with an SX-ELLA Stent Danis (ELLA-CS,
Hradec-Kralove, Czech Republic). The authors
reported immediate bleeding control in 89% (eight
of the nine cases). In one patient, the stent deploy-
ment was unsuccessful.
The second publication is another case series
reported by Zakaria et al. [28]. The authors placed
a new type of CSEMS (with European patent appli-
cation pending) in 16 patients with acute variceal
bleeding. The authors reported successful stent
deployment in 15 of the 16 patients (94%) and
www.co-gastroenterology.com 441
 Endoscopy
technical errors of placement in three (19%)
patients. Immediate control of variceal bleeding
was achieved in 14 (87.5%) patients.
Endoscopists should bear in mind that this pro-
cedure should not be used as a routine treatment for
variceal bleedings, but only as a salvage therapy in
those patients in which standard endoscopic tech-
niques have failed.
Devices for mechanical closure
In the past few years, many endoscopic suturing and
clipping devices, have been developed. Of these, the
most suitable tool for endoscopic hemostasis in
selected cases is the over-the-scope clip (OTSC)
(Ovesco Endoscopy AG, Tübingen, Germany).
The OTSC is significantly different in design
compared with the standard endoscopic clips, with
higher compression force and capacity to capture a
larger volume of tissue.
Standard hemostatic clips achieve hemostasis by
mechanical compression of the bleeding vessel, but
in some cases, the application of clips can be diffi-
cult, especially in bleeding lesions of the duodenal
bulb and the lesser curvature of the stomach and in
chronic ulcers with fibrotic changes. Another prob-
lem of clips is that these can easily dislocate, and
bleeding can reoccur.
Because of its ‘trap’ shape and dimensions (11,
12, 14 mm), the OTSC can capture larger amounts of
tissue. The principle of release of the OTSC is the
same as for a band ligator.
This OTSC is approved by the U.S. Food and
Drug Administration for endoscopic marking,
hemostasis, and closure of luminal perforations less
than 20 mm in size [15].
In the past few years, small, descriptive studies
have reported data on the efficacy and safety of the
OTSC device [29–31].
In the past 12 months, apart from some case
reports [32,33], the use of OTSC for upper non-
variceal gastrointestinal bleeding was described in
a case series by Chan et al. [34] and in a retrospective
study by Manta et al. [35].
In their case series, Chan et al. [34] used
the OTSC to control refractory or major upper
gastrointestinal bleeding from lesions in the
gastrointestinal tract in nine patients. Bleedings
were from gastric ulcers (two), duodenal ulcers
(five), gastrointestinal stromal tumor in the
stomach (one) and bleeding from pancreatic carci-
noma (one). Previous endoscopic hemostasis was
attempted in six patients, whereas in four patients,
the OTSC was placed as first treatment. The tech-
nical success was 100% and clinical effectiveness
was 77.8%.
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In their retrospective multicenter study, Manta
et al. [35] placed the OTSC in 30 patients with
bleedings in the upper and lower gastrointestinal
tract (23 and seven cases, respectively), after failure
of other hemostatic techniques. The authors
achieved hemostasis with OTSC in 27 out of 28
(96%) patients. One patient with ulcer of the
posterior duodenal wall had failure of the OTSC
procedure and underwent emergency radiological
embolization. Another two cases (duodenal bulb
and gastric ulcer) bled at 12 and 24 h after the OTSC
procedure, respectively, and were successfully treated
with endoscopic injection of saline and epinephrine.
OTSC is a promising device for nonvariceal
gastrointestinal bleedings in which other hemo-
static techniques have failed. Technically, the OTSC
can be placed on any lesion that can be treated with
a clip. As for traditional clips, technical difficulties
might arise in some bleeding lesions with necrotic
surrounding tissue. Furthermore, unlike through-
the-scope devices, the scope must be withdrawn
in order to place the OTSC device.
Long-term follow-up prospective studies are
needed to establish efficacy and safety of OTSC.
At the moment, because of its high cost, which is
threefold to fivefold higher than that of a traditional
clip [25], the OTSC is generally used where other
techniques have failed. Therefore, also cost-analysis
studies are needed.
CONCLUSION
Recently, we assisted in the development of many
novel endoscopic hemostatic devices and tech-
niques. Some of these are capable to definitively
stop bleeding, others are used as adjuvant to other
techniques and still, others are used as a bridge to
other definitive treatments.
In the past 12 months, some of the most recent
devices have been tested in case reports, case series
and clinical trials with good and promising results.
All the discussed devices are relatively new, and
more trials are needed to better establish their effi-
cacy and safety.
The doors of the endoscopic world have always
been opened to new and smart technologies that
‘make easier the life of the endoscopist’. It is con-
ceivable that very soon we will see most of the
discussed devices included in the routine armamen-
tarium of tools for endoscopic hemostasis.
Acknowledgements
None.
Conflicts of interest
There are no conflicts of interest.
Volume 30  Number 5  September 2014
 Endoscopic therapies for gastrointestinal bleeding Boškoski et al.
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