Sharmila Subramaniam1, Kesavan Kandiah1,2, Fergus Chedgy1,3, Carole Fogg4,5, Sreedhari Thayalasekaran1, Asma Alkandari1, Michelle Baker-Moffatt1, Joanne Dash1, Mark Lyons-Amos4, Gaius Longcroft-Wheaton1,6, James Brown6, Pradeep Bhandari1,6. 1. Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK. 2. Department of Gastroenterology, St George's University Hospital NHS Trust, London, UK. 3. Department of Gastroenterology, Brighton and Sussex University Hospitals NHS Trust, Brighton and Hove, UK. 4. Department of Research and Innovation, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK. 5. School of Health Sciences, University of Southampton, Southampton, UK. 6. School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK.
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. Thieme. All rights reserved.
RCT Entities:
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. Thieme. All rights reserved.
Authors: Oliver Bendall; Joel James; Katarzyna M Pawlak; Sauid Ishaq; J Andy Tau; Noriko Suzuki; Steven Bollipo; Keith Siau Journal: Clin Exp Gastroenterol Date: 2021-12-24
Authors: Federica Branchi; Rolf Klingenberg-Noftz; Kristina Friedrich; Nataly Bürgel; Severin Daum; Juliane Buchkremer; Elena Sonnenberg; Michael Schumann; Christoph Treese; Hanno Tröger; Donata Lissner; Hans-Jörg Epple; Britta Siegmund; Andrea Stroux; Andreas Adler; Winfried Veltzke-Schlieker; Daniel Autenrieth; Silke Leonhardt; Andreas Fischer; Christian Jürgensen; Ulrich-Frank Pape; Bertram Wiedenmann; Oliver Möschler; Maximilian Schreiner; Mathias Z Strowski; Volkmar Hempel; Yvonne Huber; Helmut Neumann; Christian Bojarski Journal: Surg Endosc Date: 2021-06-15 Impact factor: 4.584