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Copyright ©The Author(s) 2020.
World J Gastrointest Endosc. Jan 16, 2020; 12(1): 1-16
Published online Jan 16, 2020. doi: 10.4253/wjge.v12.i1.1
Table 5 Efficacy and safety of hemospray in the management of non-variceal upper gastrointestinal bleeding (2013-2018)
StudyType of studySample sizeBleeding sourceModalityOutcomesResults
Leblanc et al[72], 2013Case series, single arm (July 2011-March 2012)17 patientsProcedural (12/17) and malignancy related bleeding (5/17)Monotherapy or rescue therapyImmediate hemostasis, recurrent bleeding and mortality at 7 and 30 d, and related adverse eventsImmediate hemostasis achieved in 100% patient in both groups; 2 patients with recurrent bleeding with 1 of 2 with treatment failure. No adverse events. No related complications
Sakai et al[73], 2016Case report1 patientUlcer related bleedingMonotherapyImmediate hemostasisImmediate hemostasis achieved. No recurrent bleeding. No adverse events
Chen et al[55], 2015Retrospectiv single center study; (July 2011-July 2013)60 patients21 for nonmalignant nonvariceal upper gastrointestinal bleeding, 19 for malignant upper gastrointestinal bleeding, 11 for lower gastrointestinal bleeding, and 16 for intra-procedural bleedingMonotherapyImmediate hemostasis and early rebleeding (≤  72 h)Immediate hemostasis achieved in 66 cases including upper and lower (98.5 %), with 6 cases (9.5 %) of early rebleeding
Arena et al[74], 2017Retrospective cohort study; (January 2014-December 2015)A total of 15 patients, 8 males, mean age 74 yr ± 7.7Malignancy related bleedingMonotherapyImmediate hemostasis, bleeding recurrence, adverse events, clinical outcome at 1 and 6 moImmediate hemostasis achieved in 93% (14/15). 3 (21%) patients with recurrent bleeding. 12/14 (80%) with good clinical outcome at 30 d and 50% (6/12) at 6 mo. No related adverse events
Pittayanon et al[75], 2018Retrospective study; (2011-2016)99 patients (70.5% were male, age 65 ± 14 yrMalignancy related bleedingMonotherapy and adjuvant therapyImmediate hemostasis, early (≤ 3 d) and late (> 3 d) recurrent bleedingImmediate hemostasis was 97.7%, with recurrent bleeding in 15% (early) and 17% (delayed). Six-month survival was 53.4%
Baracat et al[76], 2017Case report1 patientPost-sphincterotomy bleedingRescue therapyHemostasisImmediate hemostasis achieved
González et al[77], 2016Case report1 patientPost-sclerotherapy bleedingMonotherapyHemostasisImmediate hemostasis achieved
Sung et al[78], 2011Prospective single-arm20 patients (18 men, 2 women; mean age 60.2 yr)Peptic ulcer bleeding (Forrest score Ia or Ib)MonotherapyImmediate hemostasis (max of 2 applications allowed), bleeding recurrence post-operatively, after 72 h endoscopically, and after 30 d via phone; mortality, need for surgery, and complicationsImmediate hemostasis in 95 % (19 / 20) of patients; (1/20) with a pseudoaneurysm requiring arterial embolization. Bleeding recurred in 2 patients ≤ 72 h (hemoglobin drop); neither had active bleeding at the 72-h endoscopy. No mortality, adverse events, or procedural-related complications at 30-d
Sinha et al[79], 2016Retrospective single center20 patients (median age of 75 yr; 50% men)Peptic ulcer related bleeding (forrest 1a and 1b)Adjuvant therapy to adrenaline, or to adrenaline with clips or a thermal deviceImmediate hemostasis, 7 and 30-d rebleeding; all-cause and GI-related 30-d mortalityInitial hemostasis was attained in 95% with an overall rebleeding rate (RBR) at 7 d of 16%. No difference between the 7 and 30-d RBR. Hemospray + adrenaline = 100% initial hemostasis and 25% 7-d RBR. Hemospray as third agent = 92% initial hemostasis and 9% RBR. All-cause mortality was 15% with 1 GI-related death (3%)
Haddara et al[80], 2016Prospective registry; (published 2016)202 patientsUlcer related bleeding in 75 patients, malignancy related bleed in 61 patients, procedural related bleed in 35 patients, and other in 31 patientsMonotherapy or rescue therapyFeasibility, efficacy, re-bleeding rate at day 8 and 30Application of hemospray was found to be very easy or easy in 31.7 % and 55.4 %, respectively. Immediate hemostasis achieved in 96.5 %. Re-bleeding rate at day 8 and 30 were 26.7 % and 33.5 %, respectively
Yau et al[81], 2014Retrospective (February 2012-July 2013)19 patients (mean age 67.6 yr)Peptic ulcers in 12 (63.2%) patients, Dieulafoy lesions in 2 (10.5%), mucosal erosion in 1 (5.3%), angiodysplastic lesion in 1 (5.3%), ampullectomy site in 1 (5.3%), polypectomy site in 1 (5.3%), and an unidentified lesion in 1 (5.3%)Monotherapy, adjuvant therapy, and rescue therapyImmediate hemostasis, recurrent bleeding at 7- and 30 d, mortality at 7 and 30 d (related to GIB), and adverse events (related to Hemospray)Hemostasis in 14 of 15 (93.3%) patients; Rebleeding within 7 d in 7/18 (38.9%) patients. Potential adverse events in 2 (10.5%) patients (visceral perforation and splenic infarct). Mortality in 5 (26.3%) patients with 1 with hemoperitoneum
Smith et al[82], 2014Multicenter registry (June 2011-September 2011)63 patients (44 men; median age 65)30 patients with ulcer related bleedingMonotherapy or rescue therapyImmediate hemostasis47/55 (85%) patients in monotherapy group achieved immediate hemostasis
Sulz et al[83], 2014Case series; (published in 2014)16 patientsNVUGIB, unidentifiedMonotherapy or rescue therapyImmediate hemostasisImmediate hemostasis of 93.75% (15/16)