Argon Plasma Coagulation for Barrett's Esophagus

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154748
• Other study ID #: 0102
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Low Grade Dysplasia

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)