Barretts Esophagus With Low Grade Dysplasia Clinical Trial
Official title:
Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose
NCT number | NCT04154748 |
Other study ID # | 0102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2002 |
Est. completion date | July 5, 2019 |
Verified date | November 2019 |
Source | Maria Sklodowska-Curie Institute - Oncology Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background and study aims. To evaluate the impact of power setting and proton pump inhibitor
(PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's
esophagus (BE) with low-grade dysplasia (LGD).
Patients and methods. Investigator initiated, single-center, parallel-group randomized
controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive
patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60
Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the
study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks.
Secondary outcomes included safety and long-term efficacy (at two years and at the end of a
long-term follow-up of over 4 years.
Status | Completed |
Enrollment | 71 |
Est. completion date | July 5, 2019 |
Est. primary completion date | February 10, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - consecutive adult patients with low-grade dysplasia in flat Barrett's mucosa referred for endoscopic treatment, - signed an informed consent to participate in the study. Exclusion Criteria: - high-grade dysplasia or adenocarcinoma, - visible lesions (nodules, ulcerations) in Barrett's mucosa, - serious comorbidities and short life expectancy, - coagulopathy, - pregnancy or lactation, - psychiatric disorders. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maria Sklodowska-Curie Institute - Oncology Center | Centre of Postgraduate Medical Education |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete ablation rate 6 weeks after APC treatment. | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | 6 weeks | |
Secondary | Adverse event rate during APC treatment and within 6-week post-treatment period | 6 weeks | ||
Secondary | Complete ablation rate two years after APC treatment | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | 2 years | |
Secondary | Complete ablation rate at the end of follow-up | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | Long term follow-up (>4 yars) |
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