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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2019
Source Maria Sklodowska-Curie Institute - Oncology Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Argon Plasma Coagulation 90W power

Argon Plasma Coagulation 60W power

Drug:
Omeprazole 120 mg

Omeprazole 40 mg


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Maria Sklodowska-Curie Institute - Oncology Center Centre of Postgraduate Medical Education

Outcome

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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