Retrospective Cohort Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 7, 2019; 25(13): 1592-1602
Published online Apr 7, 2019. doi: 10.3748/wjg.v25.i13.1592
Comparison of Hemospray® and Endoclot for the treatment of gastrointestinal bleeding
Francesco Vitali, Andreas Naegel, Raja Atreya, Steffen Zopf, Clemens Neufert, Juergen Siebler, Markus F Neurath, Timo Rath
Francesco Vitali, Andreas Naegel, Raja Atreya, Steffen Zopf, Clemens Neufert, Juergen Siebler, Markus F Neurath, Timo Rath, Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
Author contributions: Rath T designed the study; Vitali F, Naegel A, Atreya R, Neufert C and Rath T participated in the acquisition, analysis, and interpretation of the data, and drafted the initial manuscript; Vitali F wrote the article; Siebler J and Neurath MF revised the article critically for important intellectual content.
Institutional review board statement: The study was reviewed and approved by ethical committee of the Friedrich-Alexander-University Erlangen- Nuernberg, Germany. The scanned copy of ethical committee approval of the research protocol was attached in submitted files to the journal.
Informed consent statement: As retrospective cohort study informed patients’ consent was waived from the ethic committee
Conflict-of-interest statement: There are no conflicts of interest to report.
STROBE statement: The authors have read the STROBE Statement- checklist of items and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Timo Rath, MD, PhD, Full Professor, Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, FAU Erlangen-Nuremberg, Ulmenweg 18, Erlangen 91054, Germany.
Telephone: +49-9131-8535000 Fax: +49-9131-8535252
Received: December 22, 2018
Peer-review started: December 25, 2018
First decision: February 21, 2019
Revised: March 6, 2019
Accepted: March 11, 2019
Article in press: March 12, 2019
Published online: April 7, 2019
Research background

Gastrointestinal (GI) bleeding frequently leads to hospital admission and is associated with relevant morbidity and mortality, particularly in the elderly. Due to the increasing administration of direct oral anticoagulants in the last years and the emerging role of antiplatelet agents, sufficient and effective treatment of GI bleeding is mandatory while at the same time can be clinically challenging. In the last years, endoscopists increasingly face emergency bleeding in a clinical scenario in which coagulation parameters cannot always be corrected to normal range. Further, with increasing development of advanced endoscopic therapeutic procedures, iatrogenic bleeding after endoscopic resections represents another emerging problem. For refractory cases, hemostatic powders (HP) represent “touch-free” agents.

Research motivation

Although data on the efficacy of Endoclot (EC) are still limited, first clinical evidences suggest that both Hemospray (HS) and EC allow for effective bleeding control. Further, no direct comparison of the efficacy of these two HP is available to date.

Research objectives

Against this background we set off: (1) To analyze the short and long term success in achieving hemostasis with HP; and (2) to directly compare the two agents HS and EC in their efficacy for achieving hemostasis in a large cohort of patients treated for emergency GI bleeding in our center.

Research methods

Data were prospectively collected on patients who were treated with HS and EC for endoscopic hemostasis during emergency endoscopy between September 2013 and September 2017 in our center. Patients were followed-up for at least one month after index endoscopy and data analysis was performed after follow-up was completed

Research results

HP was applied in 154 consecutive patients (mean age 67 years) with GI bleeding in our center. Patients were followed up for at least 1 month (mean follow up: 3.2 mo). The majority of HP applications were in the upper GI tract (89%) with the following bleeding sources: Peptic ulcer disease (35%), esophageal varices (7%), tumor bleeding (11.7%), reflux esophagitis (8.7%), diffuse oozing bleeding and erosions (15.3%). Overall short term (ST) success with HP was achieved in 125 patients (81%) and long term (LT) success in 81 patients (67%). Re-bleeding occurred in 27% of all patients treated with HP. In 72 patients (47%), HP was applied as a salvage hemostatic therapy, here ST and LT success were 81% and 64%, respectively, with re-bleeding in 32% of patients. As a primary hemostatic therapy, ST and LT success were 82% and 69%, respectively, with re-bleeding occurring in 22%. Subgroup analysis showed a ST and LT efficacy for cancer bleeding of 83% and 87%, for peptic ulcer disease of 81% and 56% and in patients under therapeutic anticoagulation of 80% and 60.5%. There was no statistical difference in the ST or LT efficacy between EC and HS for the various indications; however, HS was more frequently applied for upper GI bleeding (P = 0.04)

Research conclusions

Within this study, we retrospectively analyzed the hemostatic efficacy of HPs HS and EC as first line or salvage therapy in several clinical scenarios in a large cohort of prospectively included patients. As shown in our report, both HPs allow for excellent ST bleeding control when applied as primary or salvage therapy. At the same time, LT efficacy over a period of 4 weeks is maintained in a considerable amount of patients.

Research perspectives

Both EC and HS exhibit high efficacy for achieving hemostasis in impaired coagulation status or friable tissues. With these properties, HPs represent powerful and effective additions to the armentarium of the endoscopist for treatment of GI bleeding.