Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05645679
Status:
RECRUITING
Last Update Posted:
2022-12-09
First Post:
2022-12-01
Brief Title:
Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barretts Esophagus-Related Dysplasia
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barretts Esophagus-Related Dysplasia a Multicenter Italian Prospective stuDy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYBRID
Brief Summary:
Background Barretts esophagus BE is defined by AGA as a change in the esophageal epithelium of any length that can be recognized at upper endoscopy and is confirmed to have intestinal metaplasia by biopsy It is a pre-malignant condition and may progress to low grade dysplasia high grade dysplasia and ultimately esophageal adenocarcinoma which has poor prognosis with a 5-year survival rate of only 5-20Radiofrequency ablation RFA is a standard modality and well-studied endoscopic treatment for dysplastic BE While the rate of complete eradication of dysplasia has been reported to be between 78 - 94 with RFA the rate of complications associated with this procedure has been reported to be as high as 191 and the costs are high In a randomized clinical trial in patients with BE and low-grade dysplasia by Phoa et al in 2014 68 patients underwent radiofrequency ablation therapy with a median of three ablation sessions per patient while 68 patients were randomized to endoscopic surveillance In this study a total of 13 patients 191 experienced an adverse event in the treatment group versus no adverse events in the control group Eight patients 118 developed esophageal strictures which required a median of one dilation three patients were noted to have small mucosal lacerations one patient developed retrosternal pain treated with analgesics while one patient developed abdominal pain requiring hospitalization and treatment with analgesia Several other studies have reported the rate of complications ranging between 5 to 191 and stricture formation being the most common among them Hybrid argon plasma coagulation H-APC is a newer technique that involves submucosal fluid injection prior to performing APC The injection of solutions eg 09 sodium chloride solution normal sterile saline with or without supplementation of epinephrine methylcellulose solution hydroxyethyl starch hyaluronic acid autologous blood or blood substitute fluids into the submucosa to limit the depth of thermal injury has been established both in pre-clinical studies for different tissues of the gastrointestinal tract and in the clinical practice for EMR and ESD respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None