Digestive and Liver Disease - Volume 48 - Supplement 2 - February 2016

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e220 Abstracts of the 22nd National Congress of Digestive Diseases / Digestive and Liver Disease 48S2 (2016) e67–e231
P.18.11
USE OF PILLCAM COLON 2 IN PATIENTS AT ELEVATED RISK OF
COLONOSCOPY ASSOCIATED ADVERSE EVENTS
Spada C.*1, Rex D.2, Eliakim R.3, Costamagna G.4
1Fondazione Policlinico Universitario Gemelli, Rome, Italy, 2Indiana
University Hospital, Indianapolis, United States, 3Sheba Medical Center,
Rama-Gan, Israel, 4Italy
Background and aim: Optical colonoscopy (OC) is considered as
the leading tool to visualize the colon and has a good safety profile.
However, select patients are at elevated risk of OC associated adverse
events (AEs) (referred to as “at risk”). Colon capsule endoscopy (CCE)
with PillCam® COLON 2 is intended to provide visualization of the
colon using a less invasive method, which may limit AEs in such
patients. The goal of this study was to assess the safety and accuracy
of CCE in an at risk cohort vs. those at standard risk.
Material and methods: A post-hoc analysis was performed using
the combination of four prospective, multicenter trials to assess
the CCE AE rate, exam completion rate, and accuracy in at risk vs.
standard risk patients. At risk patients were defined as those with
chronic obstructive pulmonary disease (COPD), obstructive sleep
apnea (OSA), those on prescription antithrombotics (ATs), and the
elderly (≥70 YO). OC was performed after CCE, and OC AEs were
excluded. OC-CCE lesion matching was previously described (Rex et
al., Gastroenterology, 2015).
Results: A total of 1208 subjects enrolled, 86 (7.1%) of whom were
at risk. Of these 86, 18 (21%) possessed COPD/OSA, 15 (17%) were
on ATs, and 57 (66%) were ≥70 YO. No CCE related serious adverse
events occurred. In the combined at risk group, AEs occurred in 3/86
patients (3.5%) vs. 94/1122 (8.4%) in the standard risk (p=0.15). The
CCE exam was complete in 76/86 (88.4%) of the at risk population
vs. 1026/1122 (91.4%) of those at standard risk (p=0.32). 999 subjects
were included in the accuracy analysis. CCE sensitivity for detecting
subjects with any polyp ≥6 mm in the at risk group was 88% (95% CI,
71-97) vs. 82% (95% CI, 78-86) in the standard risk group (p=0.79)
with specificities of 80% (95% CI, 64-91) and 92% (95% CI, 89-94),
respectively (p=0.10). CCE sensitivity for detecting subjects with any
polyp ≥10 mm in the at risk group was 83% (95% CI, 59-96) vs. 82%
(95% CI, 75-88) in the standard risk group (p=1.0) with specificities
of 94% (95% CI, 85-99) and 97% (95% CI, 96-98), respectively (p=0.40).
Conclusions: CCE possessed an equivalent low AE rate, high exam
completion rate, and good accuracy in patients at elevated risk of
colonoscopy associated AEs vs. those at standard risk. This suggests
that CCE could be used effectively and safely in patients with these
risk factors if they are considered poor candidates for OC.
P.18.12
HEMOSPRAY IN TREATMENT OF ACUTE BLEEDING DUE TO UPPER
GASTROINTESTINAL TUMORS: PRELIMINARY RESULTS
Arena M.*1, Luigiano C.1, Viaggi P.1, Morandi E.1, Fanti L.2, Granata A.3,
Traina M.3, Testoni P.A. 2, Masci E.4
1A.O. San Paolo, Milano, Italy, 2Ospedale San Raffaele, Milano, Italy,
3ISMETT, Palermo, Italy, 4Istituto Nazionale dei Tumori, Milano, Italy
Background and aim: Acute bleeding can complicate upper
gastrointestinal (UGI) tumors. Endoscopic treatment in these cases
is associated to a lower success rate than in case of bleeding due
to other causes. Initial endoscopic hemostasis with traditional
methods ranges from 67% to 100%, but re-bleeding rate is about
30%. Hemospray is a new hemostatic powder that is revealing
successful in GI bleeding conditions. Aims of this study is to assess
the Hemospray’s efficacy to stop neoplastic UGI bleeding and to
evaluate re-bleeding rate after initial hemostasis with Hemospray.
Material and methods: Prospective, multicenter, not randomized
study on consecutive patients with acute bleeding from UGI
neoplastic lesions. Hemospray was used as single therapy or
in association to other endoscopic hemostatic treatments. We
evaluated initial hemostatic efficacy with Hemospray and any re-
bleeding defined as early (until 3 days) or late (> 3 days). We defined
effective hemostasis as stop of bleeding after 5 minutes or more from
the end of treatment and re-bleeding as reduction of hemoglobin > 2
g/dl and endoscopic signs of bleeding.
Results: We enrolled 13 consecutive patients with UGI neoplastic
bleeding. One patient presented with melena, hematemesis and
shock, six patients with anemia and melena, three with anemia,
and two with melena. Hemoglobin values ranged from 4 to 11 g/dl.
Seven patients had gastric cancer, five patients had duodenal cancer,
and one had a duodenal metastases due to melanoma. All patients
showed endoscopic oozing bleeding. Hemospray was used as single
therapy in 9 patients with immediate outcome in 100%. One of
these patients presents early re-bleeding, treated successfully with
Hemospray without further bleeding. Four patients were treated
with Hemospray in association with other endoscopic methods
(2 with injection therapy; 1 with mechanic therapy and 1 with
thermic and mechanic therapies. Among these four patients, two
had successful hemostasis without re-bleeding; one presented early
and late re-bleeding after initial hemostasis and finally he died from
causes related to bleeding; one patient failed initial endoscopic
hemostasis, so he underwent surgery and died after few hours.
Conclusions: In this case series we found that initial hemostasis
with Hemospray in patients with UGI neoplastic bleeding is about
92%, and re-bleeding rate is about 17%. According with these
preliminary results Hemospray is a useful endoscopic treatment in
acute bleeding due to UGI tumors.
P.18.13
HEMOSPRAY AS FIRST-LINE AND RESCUE THERAPY FOR
GASTROINTESTINAL BLEEDING
Pigò F.*, Bertani H., Manno M., Caruso A., Mirante V.G., Barbera C.,
Mangiafico S., Conigliaro R.L.
Nuovo Ospedale Civile S. Agostino Estense, Modena, Italy
Background and aim: Among devices employed for gastrointestinal
bleeding (GIB), Hemospray (Cook Medical, Winston-Salem, North
Carolina, USA) is a new promising tool because of its efficacy, safety
and simple use. Hemospray is an hemostatic inorganic agent that
becomes adhesive in contact with blood, creating a mechanical
barrier. In Europe, Hemospray is licensed for upper gastrointestinal
bleeding. The current use in the lower gastrointestinal tract is “off-
label”. We present a prospective case series pointing the use of
Hemospray in daily routine for the treatment of GIB at our tertiary
endoscopy center.
Material and methods: Patients treated with Hemospray between
January 2014 and July 2015 were involved in this study. Informations
as age, sex, ASA class, antithrombotic/anticoagulant use, presence
of shock, cause of bleeding, previous internventions, additional
modalities of hemostasis, rebleeding and mortality to 30 days
were collected. In every case the technique was feasible and it was
administered a maximum of 20 g of the powder. In 1 case Hemospray
was used “off-label”.
Results: 13 patients were treated with Hemospray as first line
therapy in 7 cases and as rescue therapy in 6 cases. In 8 cases (3
gastric neoplasia, gastrojejunal anastomosis, ischemic colitis, 1
post-sphincterotomy bleeding, esophageal ulcer) no more bleeding
episodes occurred. In 3 cases of duodenal ulcers angiography and/or
surgery were necessary to stop bleeding. 3 patients died within 30
days from admission (2 gastric neoplasia and 1 duodenal ulcer). No
adverse events were registered.