Argon Plasma Coagulation for Barrett's Esophagus

Not Applicable

Completed

• Conditions: Barretts Esophagus With Low Grade Dysplasia
• Interventions: Device: Argon Plasma Coagulation 90W power; Device: Argon Plasma Coagulation 60W power; Drug: Omeprazole 40 mg; Drug: Omeprazole 120 mg

• Registration Number: NCT04154748
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-04
• Primary Completion: 2015-02-10
• Study Completion: 2019-07-05
• Status Verified: 2019-11
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APC 90W / PPI 40mg	Omeprazole 40 mg	treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)
APC 90W / PPI 120mg	Argon Plasma Coagulation 90W power	treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
APC 60 W/ PPI 120mg	Argon Plasma Coagulation 60W power	treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
APC 90W / PPI 40mg	Argon Plasma Coagulation 90W power	treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)
APC 90W / PPI 120mg	Omeprazole 120 mg	treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
APC 60 W/ PPI 120mg	Omeprazole 120 mg	treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Primary Outcome Measures

Name	Time	Method
Complete ablation rate 6 weeks after APC treatment.	6 weeks	Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

Secondary Outcome Measures

Name	Time	Method
Adverse event rate during APC treatment and within 6-week post-treatment period	6 weeks
Complete ablation rate two years after APC treatment	2 years	Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
Complete ablation rate at the end of follow-up	Long term follow-up (>4 yars)	Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands