Argon Plasma Coagulation for Barrett's Esophagus

NCT04154748 | Completed

• 1 other identifier: 0102
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Barretts Esophagus With Low Grade Dysplasia

Keywords

Barretts Esophagus; Dysplasia; Argon Plasma Coagulation; Endoscopic Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 rate at the end of follow-up

  Long term follow-up (>4 yars)

Study Arms (3)

APC 90W / PPI 120mg

EXPERIMENTAL

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Device: Argon Plasma Coagulation 90W power; Drug: Omeprazole 120 mg

APC 90W / PPI 40mg

ACTIVE COMPARATOR

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)

Device: Argon Plasma Coagulation 90W power; Drug: Omeprazole 40 mg

APC 60 W/ PPI 120mg

ACTIVE COMPARATOR

treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Device: Argon Plasma Coagulation 60W power; Drug: Omeprazole 120 mg

Interventions

Argon Plasma Coagulation 90W power DEVICE

APC 90W / PPI 120mg; APC 90W / PPI 40mg

Argon Plasma Coagulation 60W power DEVICE

APC 60 W/ PPI 120mg

Omeprazole 120 mg DRUG

APC 60 W/ PPI 120mg; APC 90W / PPI 120mg

Omeprazole 40 mg DRUG

APC 90W / PPI 40mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator

Related Publications (1)

• Wronska E, Polkowski M, Orlowska J, Mroz A, Wieszczy P, Regula J. Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose. Endoscopy. 2021 Feb;53(2):123-132. doi: 10.1055/a-1203-5930. Epub 2020 Jul 10.

  PMID: 32650347 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were blinded to the power settings used for APC, but they knew the PPI dose they received. The endoscopist performing APC ablation was blinded to participant allocation and APC power setting (the power was set up by an assistant who knew the group allocation and the power display remained covered during the entire procedure). The endoscopist and pathologist involved in efficacy assessment were blinded to participant allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 6, 2019
• Study Start: June 4, 2002
• Primary Completion: February 10, 2015
• Study Completion: July 5, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11