Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal
Colorectal PolypsEuropean guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy
Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial...
Chronic Rhinosinusitis With Nasal PolypsAsthmaMepolizumab is a biologic agent already approved for severe asthma. Recently, there is increasing evidence concerning the benefit of anti-IL5 treatments upon patients with nasal polyposis with or without severe asthma. The novelty of this project is that no biologic agent has yet been fully investigated to identify any biomarkers of response for patients with nasal polyps with or without asthma including sinonasal tissue remodeling a key element in the resultant histopathological changes of the inflammation. The investigation of airway remodeling of various locations (nose and bronchus) under mepolizumab treatment will be our primary objective on the long-term basis of 156 weeks of treatment. Endobronchial and nasal biopsies will be performed as routine care for tissue evauation and disease investigation for every patient. Besides, the united airways will provide better guidance for medical treatment of chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) and asthma. The initial idea is based on investigating the characteristics that could predict the effectiveness of mepolizumab on patients with nasal polyposis with or without asthma. Patients will receive 39 doses of mepolizumab for 156 weeks. An additional aim of this study is to identify characteristics of non-responders and responders to mepolizumab. Responders will be identified based on airway remodeling status, biomarkers in tissue and secretion samples and on the reduction of the need of surgery through Lund-Kennedy endoscopic score, Lund-Mackay score and patient's clinical status in the 6th, 12th and 36th month after the initiation of treatment. Regarding the unified airway system, nose and pharyngeal microbiome will be evaluated before and after 52 weeks of mepolizumab treatment in patients with nasal polyps whereas in patients with nasal polyps and asthma bronchus microbiome will also be evaluated. Lung samples will help gain information about the inflammatory profile and local microbiome of CRSwNP patients with asthma through molecular and cellular assays. The human Pharyngeal Microbiome might play a protective role in Respiratory Tract Infections and it has been reported that the microbiome provides critical signals to promote maturation of immune cells and differentiation of the tissue. Thus, we will make an effort to correlate microbiome of various locations with clinical and laboratory characteristics of responders and non-responders to mepolizumab treatment.
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant...
Shared Decision MakingColonic Polyp4 moreManagement of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process. This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective. Secondary Objectives: To evaluate the efficacy of dupilumab in improving total symptoms score (TSS). To evaluate the efficacy of dupilumab in improving sense of smell. To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan). To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery. To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22). To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [ERD]). To evaluate residual effect in follow up. To evaluate the safety of dupilumab in participants with bilateral NP. To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps
Colonic PolypIntestinal PolypBackground:The optimal technique for removal of diminutive or small colorectal polyps is debatable. Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm). Design:Prospective randomized controlled study. Setting:Three tertiary referral hospitals. Patients:we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a computer-generated random sequence. If a patient had one or more polyps, all eligible polyps were removed using the initially assigned polypectomy protocol. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue. Main Outcome Measurements:The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).
Injection-Assisted Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Small Colorectal...
Colonic PolypsComplete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may arise as a consequence of incomplete polypectomy. However, the ideal method to remove small colorectal polyps remains uncertain. The investigators designed a randomized controlled trial to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the resection of small (6-10mm) colorectal polyps.
Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps...
Nasal PolypsThis randomized, double-blind, placebo-controlled clinical trial enrolled subjects with eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation suspension or placebo for 14 days. Visual analogue scales (VAS)of nasal symptoms, endoscopic polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry; and frequencies of different inflammatory T cell infiltration by flow cytometry. this study is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation suspension via transnasal nebulization by clinical and immunologic assessments. As outcome parameters for remodeling, differences in the expression of collagen and albumin were investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs expression differences in nasal polyps were investigated to explore underlying mechanisms of tissue reconstitution.
Microwave Coagulation Using CROMA Electrosurgical System
Polyp of Large IntestineThis is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.
Selenium for Prevention of Adenomatous Colorectal Polyps
Colorectal CancerAdenomatous Colorectal Polyps1 moreRATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps. PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Usefulness of NBI for Complete Endoscopic Resection of SSA/P
Sessile Serrated Adenoma/PolypsThis study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after randomization for the evaluation of remnant lesion. Additional resection will be performed for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for evaluation of complete resection.