Endoscopy 2016; 48(12): 1084-1095
DOI: 10.1055/s-0042-116148
Original article
© Georg Thieme Verlag KG Stuttgart · New York

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the “GRAPHE” registry)

Sami Haddara*
1   Institut des Maladies de l’Appareil Digestif, University Hospital, Nantes, France
,
Jeremie Jacques*
2   Service d’Hépato-gastro-entérologie, CHU Dupuytren, Limoges, France
,
Stéphane Lecleire
3   Service d’Hépato-gastro-entérologie, CHU Charles Nicolle, Rouen, France
,
Julien Branche
4   Service d’Hépato-gastro-entérologie, CHU Lille, Lille, France
,
Sarah Leblanc
5   Service d’Hépato-gastro-entérologie, CHU Cochin, Paris, France
,
Yann Le Baleur
6   Service d’Hépato-gastro-entérologie, CHU Henri-Mondor, Paris, France
,
Jocelyn Privat
7   Service d’Hépato-gastro-entérologie, CH Vichy, Vichy, France
,
Laurent Heyries
8   Service d’Hépato-gastro-entérologie, CHU La Timone, Marseille, France
,
Philippe Bichard
9   Service d’Hépato-gastro-entérologie, Hopitaux Universitaires de Genève, Geneva, Switzerland
,
Philippe Granval
8   Service d’Hépato-gastro-entérologie, CHU La Timone, Marseille, France
,
Ulriikka Chaput
10   Service d’Hépato-gastro-entérologie, CHU Saint-Antoine, Paris, France
,
Stephane Koch
11   Service d’Hépato-gastro-entérologie, CHU Besançon, Besançon, France
,
Jonathan Levy
12   Clinique des Cèdres, Cornebarrieu, France
,
Bruno Godart
13   Service d’Hépato-gastro-entérologie, CHU Tours, Tours, France
,
Antoine Charachon
14   Service d’Hépato-gastro-entérologie, CH Princesse Grace, Monaco
,
Jean-François Bourgaux
15   Service d’Hépato-gastro-entérologie, CHU Caremeau, Nîmes, France
,
Elodie Metivier-Cesbron
16   Service d’Hépato-gastro-entérologie, CHU Angers, Angers, France
,
Edouard Chabrun
17   Service d’Hépato-gastro-entérologie, CHU Bordeaux, Bordeaux, France
,
Vincent Quentin
18   Service d’Hépato-gastro-entérologie, CH Saint-Brieuc, Saint-Brieuc, France
,
Bastien Perrot
19   EA 4275, Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences, University of Nantes, Nantes, France
,
Geoffroy Vanbiervliet
20   Service d’Hépato-gastro-entérologie, CHU L’Archet, Nice, France
,
Emmanuel Coron
1   Institut des Maladies de l’Appareil Digestif, University Hospital, Nantes, France
21   Inserm Unit 913, University of Nantes, Nantes, France
› Author Affiliations
Further Information

Publication History

submitted 09 April 2016

accepted after revision 22 July 2016

Publication Date:
19 October 2016 (online)

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice.

Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding.

Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy.

Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed.

Trial registration: ClinicalTrials.gov (NCT02595853)

* These authors contributed equally to this work.