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

Sharmila Subramaniam; Kesavan Kandiah; Fergus Chedgy; Carole Fogg; Sreedhari Thayalasekaran; Asma Alkandari; Michelle Baker-Moffatt; Joanne Dash; Mark Lyons-Amos; Gaius Longcroft-Wheaton; James Brown; Pradeep Bhandari

doi:10.1055/a-1198-0558

Endoscopy, Inhaltsverzeichnis

Endoscopy 2021; 53(01): 27-35
DOI: 10.1055/a-1198-0558

Original article

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

Sharmila Subramaniam

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Kesavan Kandiah

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

²Department of Gastroenterology, St George's University Hospital NHS Trust, London, UK

,

Fergus Chedgy

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

³Department of Gastroenterology, Brighton and Sussex University Hospitals NHS Trust, Brighton and Hove, UK

,

Carole Fogg

⁴Department of Research and Innovation, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

⁵School of Health Sciences, University of Southampton, Southampton, UK

,

Sreedhari Thayalasekaran

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Asma Alkandari

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Michelle Baker-Moffatt

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Joanne Dash

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Mark Lyons-Amos

⁴Department of Research and Innovation, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

,

Gaius Longcroft-Wheaton

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

⁶School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK

,

James Brown

⁶School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK

,

Pradeep Bhandari

¹Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK

⁶School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK

› Institutsangaben

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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Referenzen

References
1 Enomoto S, Yahagi N, Fujishiro M. et al. Novel endoscopic hemostasis technique for use during endoscopic submucosal dissection. Endoscopy 2007; 39: E156
2 Hotta K, Yamaguchi Y, Saito Y. et al. Current opinions for endoscopic submucosal dissection for colorectal tumors from our experiences: Indications, technical aspects and complications. Dig Endosc 2012; 24: 110-116
3 Yamashina T, Takeuchi Y, Uedo N. et al. Features of electrocoagulation syndrome after endoscopic submucosal dissection for colorectal neoplasm. J Gastroenterol Hepatol 2016; 31: 615-620
4 Kataoka Y, Tsuji Y, Sakaguchi Y. et al. Bleeding after endoscopic submucosal dissection: Risk factors and preventive methods. World J Gastroenterol 2016; 22: 5927-5935
5 Nishizawa T, Suzuki H, Goto O. et al. Effect of prophylactic clipping in colorectal endoscopic resection: A meta-analysis of randomized controlled studies. United European Gastroenterol J 2017; 5: 859-867
6 Park CH, Lee SK. Preventing and controlling bleeding in gastric endoscopic submucosal dissection. Clinical Endoscopy 2013; 46: 456-462
7 Takizawa K, Oda I, Gotoda T. et al. Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection - An analysis of risk factors. Endoscopy 2008; 40: 179-183
8 Mourad FH, Leong RW. Role of hemostatic powders in the management of lower gastrointestinal bleeding: A review. J Gastroenterol Hepatol 2018; 33: 1445-1553
9 Huang R, Pan Y, Hui N. et al. Polysaccharide hemostatic system for hemostasis management in colorectal endoscopic mucosal resection. Dig Endosc 2014; 26: 63-68
10 Leung GKK, Wang YC, Wu W. Peptide nanofiber scaffold for brain tissue reconstruction. Methods Enzymol 2012; 508: 177-190
11 Xu FF, Wang YC, Sun S. et al. Comparison between self-assembling peptide nanofiber scaffold (SAPNS) and fibrin sealant in neurosurgical hemostasis. Clin Transl Sci 2015; 8: 490-494
12 Luo Z, Wang S, Zhang S. Fabrication of self-assembling d-form peptide nanofiber scaffold d-EAK16 for rapid hemostasis. Biomaterials 2011; 32: 2013-2020
13 Ye ZY, Zhang HY, Luo HL. et al. Temperature and pH effects on biophysical and morphological properties of self-assembling peptide RADA16-1. J Pept Sci 2008; 14: 152-162
14 Song H, Zhang L, Zhao X. Hemostatic efficacy of biological self-assembling peptide nanofibers in a rat kidney model. Macromol Biosci 2010; 10: 33-39
15 Masuhara H, Fujii T, Watanabe Y. et al. Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery. Ann Thorac Cardiovasc Surg 2012; 18: 444-451
16 Lee MF, Ma Z, Ananda A. A novel haemostatic agent based on self-assembling peptides in the setting of nasal endoscopic surgery, a case series. Int J Surg Case Rep 2017; 41: 461-464
17 Giritharan S, Salhiyyah K, Tsang G. et al. Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery. J Cardiothorac Surg 2018; 13: 68
18 Uraoka T, Ochiai Y, Fujimoto A. et al. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc 2016; 83: 1259-1264
19 Pioche M, Camus M, Rivory J. et al. A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections. Endosc Int Open 2016; 4: E415-E419
20 Yoshida M, Goto N, Kawaguchi M. et al. Initial clinical trial of a novel hemostat, TDM-621, in the endoscopic treatments of the gastric tumors. J Gastroenterol Hepatol 2014; 29 (Suppl. 04) 77-79
21 Veitch AM, Vanbiervliet G, Gershlick AH. et al. Endoscopy in patients on antiplatelet or anticoagulant therapy, including Direct Oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal endoscopy (ESGE) guidelines. Gut 2016; 65: 374-389
22 Subramaniam S, Kandiah K, Thayalasekaran S. et al. Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide. United European Gastroenterol J 2019; 7: 155-162
23 Sakita T, Fukutomi H. Endoscopic Diagnosis: Ulcer of Stomach and Duodenum. Tokyo: Nankodo; 1971: 198-208
24 Fuccio L, Hassan C, Ponchon T. et al. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc 2017; 86: 74-86
25 Barret M, Lepilliez V, Coumaros D. et al. The expansion of endoscopic submucosal dissection in France: A prospective nationwide survey. United European Gastroenterol J 2017; 5: 45-53
26 Barret M, Bordacahar B, Beuvon F. et al. Self-assembling peptide matrix for the prevention of esophageal stricture after endoscopic resection: a randomized controlled trial in a porcine model. Dis Esophagus 2017; 30: 1-7