None listed
Conditions
Brief summary
The primary purpose of this pilot trial is to evaluate the efficacy and safety of Hybrid-APC ablation for the treatment of Barrett's oesophagus. Who is it for? You may be eligible to participate in this trial if you are aged 18-85 years and have been diagnosed with Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma. Study details All participants enrolled in this trial will receive the Hybrid-APC ablation procedure which involves an gastroscopy with use of so called Hybrid-APC ablation. This means that a saline solution (NaCl 0.9%) will be injected into the submucosal lining of the affected area and thereafter the affected tissue will be coagulated using APC. Participants will then be followed up every three months during 5 years of follow-up to assess disease progression and whether any additional procedures are required. It is hoped that the findings from this pilot trial will provide preliminary information regarding the safety and efficacy of ablation for Barrett's oesophagus, which may be used to inform larger clinical trials in the future.
Interventions
Therapeutic intervention for patients with dysplastic barrett's oesophagus or early oesophageal cancer. Patients will undergo hybrid-Argon plasma coagulation during gastroscopy to ablate the dysplastic tissue. This will involve removal of visible lesions of Barrett’s Oesophagus that will be confirmed by microscopic assessment as part of clinical care. During the gastroscopy a salt-water solution will be injected into the submucosa of the oesophageal wall and thereafter the affected area will be
Therapeutic intervention for patients with dysplastic barrett's oesophagus or early oesophageal cancer. Patients will undergo hybrid-Argon plasma coagulation during gastroscopy to ablate the dysplastic tissue. This will involve removal of visible lesions of Barrett’s Oesophagus that will be confirmed by microscopic assessment as part of clinical care. During the gastroscopy a salt-water solution will be injected into the submucosa of the oesophageal wall and thereafter the affected area will be treated with Argon Plasma Coagulation. The procedure will be performed by dr Saxena, who is a highly qualified gastroenterologist and specialized in the treatment of barretts oesophagus. The procedure will approximately take 30 minutes. Thereafter patients will be followed during a follow-up period of 5 years.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma
Exclusion criteria
a) C value greater than 6 cm using the Prague criteria b) Prior ER for adenocarcinoma with histological diagnosis of greater than or equal to T1b; c) Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional endoscopic resection is allowed); d) Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial HAPC treatment without endoscopic resection of cancer lesion for staging; e) Pregnancy f) Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated; g) Patients with incomplete healing post-endoscopic resection despite adequate PPI-medication; h) Prior ablative therapy in the oesophagus; i) Significant oesophageal stenosis prior to initial HAPC treatment defined as a stenosis that cannot be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before. j) Presence of esophageal varices k) Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to HAPC or incorrectable hemostatic disorders l) Life expectancy less than 2 years
Outcome results
None listed