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Assessing the safety of routine snare tip soft coagulation (STSC) in patients undergoing endoscopic mucosal resection for large polyps during colonoscopy

ABSTRACT: Interventions: We are assessing whether additional snare tip soft coagulation (STSC) therapy applied to the resection margins of a defect following piecemeal removal of a large colonic polyp without electrocautery will reduce the risk of polyp recurrence. The safety profile of this intervention will also be assessed (although it has been found to be safe in other large multicentre studies). STSC will be performed using the wire tip of a polypectomy snare. The tip is positioned 1-2mm beyond the end of the snare sheath and thermal ablation is applied to the edges of the polypectomy defect margins using this tip with the assistance of a microprocessor-controlled generator (SOFT COAG mode, 80W Effect 4, ERBE Electromedizin, Tubingen, Germany). The aim will be to create a 2mm circumferential rim of completely ablated tissue around the defect. This typically requires up to 5 minutes of additional procedure time and will be delivered to patients streamlined to the intervention arm of the study. Photodocumentation will be required following STSC. This will be performed by gastroenterologists who have experience in both resection of large polyps and application of STSC. Primary outcome(s): Rate of adenoma recurrence following polypectomy +/- STSC. These outcomes will be reviewed at the 6-month mark following a routine post-EMR colonoscopy. Visual inspection and biopsies of the polypectomy site will be obtained. [6 months after index colonoscopy (ie. initial polypectomy procedure)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Colonic Polyp,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2754978 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Chronic rhinosinusitis with nasal polyposis (CRSwNP) in western countries is characterized by eosinophilia, IgE production and Th2 cytokine expression. Type 2 innate lymphoid cells (ILC2) from polyps produce IL-5 and IL-13 in response to IL-25 and IL-33 although the relevance of this axis to local mucosal T cell responses is unknown. Objective: To investigate the role of the IL-25/IL-33 axis in local mucosal T cell responses in CRSwNP. Methods: Polyp tissue and blood were obtained from patients undergoing nasal polypectomy. Control nasal biopsies and blood were obtained from healthy volunteers. Tissue was cultured in a short-term explant model. T cell surface phenotype/intracellular cytokines were assessed by flow cytometry. TCR VÎ² analysis was performed with the immunoSEQ assay. Microarrays were performed for gene expression analysis. Results: Using nasal polyp tissue, numerous IL-25 receptor (IL-17RB) positive polarized Th2 cells were identified which were absent in the healthy nasal mucosa and periphery. IL-17RB+CD4+ polyp Th2 cells co-expressed ST2 (IL-33 receptor) and responded to IL-25 and IL-33 with enhanced IL-5 and IL-13 production. Within IL-17RB+CD4+ T cells several identical TCR VÎ² CDR3 sequences were identified in different subjects suggesting clonal expansion driven by a common antigen. Abundant IL-17 producing T cells were observed in healthy nasal mucosal and polyp populations with Th17-related genes the most overexpressed compared to peripheral blood T cells. Conclusion: IL-25 and IL-33 may interact locally with IL-17RB+ST2+ polyp T cells to augment Th2 responses in CRSwNP. A local Th17 response may be the default signature in healthy nasal mucosal immune homeostasis. Three biological replicates. T-helper cells were isolated nasal polyps by explant culture from patients with chronic rhinosinusitis. Cells were then sorted based upon expression of IL17RB by flow cytometric sorting. Resting and activated IL-17RB+ve cells were compared with resting and activated IL-17RB-ve cells.

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Assessing the safety of routine snare tip soft coagulation (STSC) in patients undergoing endoscopic mucosal resection for large polyps during colonoscopy

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