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A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomised controlled trial

A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomised controlled trial
A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomised controlled trial

Background  Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. Methods  This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. Results  There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P  < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P  = 0.02). Conclusions  This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

0013-726X
27-35
Subramaniam, Sharmila
4994d15f-b6cb-4ff5-ae83-ddf429807bfa
Kandiah, Kesavan
89a679c5-2e96-4ea9-8d4c-b03e35fff94e
Chedgy, Fergus
0c86daaa-5064-4383-990e-5e76b3e348db
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Thayalasekaran, Sreedhari
faeaf07c-7303-46ae-a400-c06754712695
Alkandari, Asma
e0500692-ff32-4722-921e-be8e214c66df
Baker-Moffatt, Michelle
e8c198f2-d06e-4495-8807-38989a27eb14
Dash, Joanne
d2bcaf3f-78f3-4618-81c4-55cdca57d8dc
Longcroft-Wheaton, Gaius
64dd8c07-1e26-4b7d-8806-9e84495b39aa
Brown, James
dec266a5-ae8d-4351-963f-553c8d1b7b0c
Bhandari, Pradeep
9d37fe08-4c8f-4d82-b3aa-52ba48706e15
Subramaniam, Sharmila
4994d15f-b6cb-4ff5-ae83-ddf429807bfa
Kandiah, Kesavan
89a679c5-2e96-4ea9-8d4c-b03e35fff94e
Chedgy, Fergus
0c86daaa-5064-4383-990e-5e76b3e348db
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Thayalasekaran, Sreedhari
faeaf07c-7303-46ae-a400-c06754712695
Alkandari, Asma
e0500692-ff32-4722-921e-be8e214c66df
Baker-Moffatt, Michelle
e8c198f2-d06e-4495-8807-38989a27eb14
Dash, Joanne
d2bcaf3f-78f3-4618-81c4-55cdca57d8dc
Longcroft-Wheaton, Gaius
64dd8c07-1e26-4b7d-8806-9e84495b39aa
Brown, James
dec266a5-ae8d-4351-963f-553c8d1b7b0c
Bhandari, Pradeep
9d37fe08-4c8f-4d82-b3aa-52ba48706e15

Subramaniam, Sharmila, Kandiah, Kesavan, Chedgy, Fergus, Fogg, Carole, Thayalasekaran, Sreedhari, Alkandari, Asma, Baker-Moffatt, Michelle, Dash, Joanne, Longcroft-Wheaton, Gaius, Brown, James and Bhandari, Pradeep (2021) A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomised controlled trial. Endoscopy, 53 (1), 27-35. (doi:10.1055/a-1198-0558).

Record type: Article

Abstract

Background  Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. Methods  This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. Results  There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P  < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P  = 0.02). Conclusions  This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

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A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection a randomised controlled trial - Accepted Manuscript
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Accepted/In Press date: 6 May 2020
e-pub ahead of print date: 17 July 2020
Published date: 1 January 2021
Additional Information: Publisher Copyright: © 2021 Georg Thieme Verlag. All rights reserved.

Identifiers

Local EPrints ID: 441379
URI: http://eprints.soton.ac.uk/id/eprint/441379
ISSN: 0013-726X
PURE UUID: d507bcfc-47c0-47e9-bb10-4118d9219a0c
ORCID for Carole Fogg: ORCID iD orcid.org/0000-0002-3000-6185

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Date deposited: 11 Jun 2020 16:30
Last modified: 17 Mar 2024 05:38

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Contributors

Author: Sharmila Subramaniam
Author: Kesavan Kandiah
Author: Fergus Chedgy
Author: Carole Fogg ORCID iD
Author: Sreedhari Thayalasekaran
Author: Asma Alkandari
Author: Michelle Baker-Moffatt
Author: Joanne Dash
Author: Gaius Longcroft-Wheaton
Author: James Brown
Author: Pradeep Bhandari

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