Open Access
CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(10): E1220-E1229
DOI: 10.1055/a-2406-7492
Original article

Efficacy of novel endoscopic hemostatic agent for bleeding control and prevention: Results from a prospective, multicenter national registry

Roberta Maselli
1   Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (Ringgold ID: RIN9268)
2   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy (Ringgold ID: RIN437807)
,
Leonardo Da Rio
1   Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (Ringgold ID: RIN9268)
,
Mauro Manno
3   Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Modena, Italy (Ringgold ID: RIN18067)
,
Paola Soriani
3   Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Modena, Italy (Ringgold ID: RIN18067)
,
Gianluca Andrisani
4   Digestive Endoscopy Unit, Campus Bio-Medico University, Rome, Italy (Ringgold ID: RIN9317)
,
Francesco Maria Di Matteo
5   Operative Endoscopy Department, Campus Bio-Medico University Hospital, Roma, Italy (Ringgold ID: RIN220431)
,
Carlo Fabbri
6   Gastroenterology and Digestive Endoscopy Unit, Forli-Cesena Hospitals, AUSL Romagna, Forlì Cesena, Italy
,
Monica Sbrancia
6   Gastroenterology and Digestive Endoscopy Unit, Forli-Cesena Hospitals, AUSL Romagna, Forlì Cesena, Italy
,
Cecilia Binda
6   Gastroenterology and Digestive Endoscopy Unit, Forli-Cesena Hospitals, AUSL Romagna, Forlì Cesena, Italy
,
Alba Panarese
7   Division of Gastroenterology and Digestive Endoscopy, Department of Medical Sciences, Central Hospital, Taranto, Taranto, Italy
,
Fulvio D'Abramo
7   Division of Gastroenterology and Digestive Endoscopy, Department of Medical Sciences, Central Hospital, Taranto, Taranto, Italy
,
Teresa Staiano
8   Digestive Endoscopy Unit, Candiolo Cancer Institute, FPO - IRCCS Candiolo, Turin, Italy (Ringgold ID: RIN18524)
,
Stefano Rizza
8   Digestive Endoscopy Unit, Candiolo Cancer Institute, FPO - IRCCS Candiolo, Turin, Italy (Ringgold ID: RIN18524)
,
9   Experimental Oncological Gastroenterology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Italy (Ringgold ID: RIN9355)
,
Stefania Maiero
9   Experimental Oncological Gastroenterology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Italy (Ringgold ID: RIN9355)
,
Vittoria Stigliano
10   Gastroenterology & Digestive Endoscopy, Regina Elena Institute, Rome, Italy (Ringgold ID: RIN18658)
,
Germana de Nucci
11   Gastroenterology and Endoscopy Unit, Aziende Socio Sanitaria Territoriale Rhodense, Garbagnate Milanese, Milan, Italy (Ringgold ID: RIN472771)
,
11   Gastroenterology and Endoscopy Unit, Aziende Socio Sanitaria Territoriale Rhodense, Garbagnate Milanese, Milan, Italy (Ringgold ID: RIN472771)
,
Marco Sacco
12   Gastro-Hepatology Unit, Department of Medical Sciences, University of Turin, Turin, Italy (Ringgold ID: RIN9314)
,
13   Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy (Ringgold ID: RIN18972)
,
1   Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (Ringgold ID: RIN9268)
2   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy (Ringgold ID: RIN437807)
,
Alessandro Repici
1   Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (Ringgold ID: RIN9268)
2   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy (Ringgold ID: RIN437807)
› Author Affiliations
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Abstract

Background and study aims Topical hemostatic agents emerged as a new treatment modality for gastrointestinal bleeding. The aim of this study was to assess the safety and efficacy of PuraStat for control of active bleeding and for prevention of bleeding after different operative endoscopy procedures.

Patients and methods A national, multicenter, observational registry was established to collect data from ten Italian centers from June 2021 to February 2023. Demographics, type of application (active gastrointestinal bleeding or prevention after endoscopic procedures, site, amount of gel used, completeness of coverage of the treated area), outcomes (rates of intraprocedural hemostasis and bleeding events during 30-day follow-up), and adverse events (AEs) were prospectively analyzed.

Results Four hundred and one patients were treated for active gastrointestinal bleeding or as a preventive measure after different types of operative endoscopy procedures. Ninety-one treatments for active bleeding and 310 preventive applications were included. In 174 of 401 cases (43.4%), PuraStat was the primary treatment modality. Complete coverage was possible in 330 of 401 (82.3%) with difficulty in application in seven of 401 cases (1.7%). Hemostasis of active bleedings was achieved in 90 of 91 patients (98.9%). In 30-day follow-up 3.9% patients in whom PuraStat was used for prophylaxis had a bleeding event compared with 7.7% after hemostasis. No AEs related to the use of PuraStat were reported.

Conclusions PuraStat is a safe and effective hemostat both for bleeding control and for bleeding prevention after different operative endoscopy procedures. Our results suggest that the possible applications for the use of PuraStat may be wider compared with current indications.



Publication History

Received: 09 April 2024

Accepted after revision: 29 August 2024

Accepted Manuscript online:
18 September 2024

Article published online:
28 October 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Bibliographical Record
Roberta Maselli, Leonardo Da Rio, Mauro Manno, Paola Soriani, Gianluca Andrisani, Francesco Maria Di Matteo, Carlo Fabbri, Monica Sbrancia, Cecilia Binda, Alba Panarese, Fulvio D'Abramo, Teresa Staiano, Stefano Rizza, Renato Cannizzaro, Stefania Maiero, Vittoria Stigliano, Germana de Nucci, Gianpiero Manes, Marco Sacco, Antonio Facciorusso, Cesare Hassan, Alessandro Repici. Efficacy of novel endoscopic hemostatic agent for bleeding control and prevention: Results from a prospective, multicenter national registry. Endosc Int Open 2024; 12.
DOI: 10.1055/a-2406-7492