Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Argon Plasma Coagulation for Barrett's Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154748
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Centre of Postgraduate Medical Education
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

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.


Condition or disease Intervention/treatment Phase
Barretts Esophagus With Low Grade Dysplasia Device: Argon Plasma Coagulation 90W power Device: Argon Plasma Coagulation 60W power Drug: Omeprazole 120 mg Drug: Omeprazole 40 mg Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2002
Actual Primary Completion Date : February 10, 2015
Actual Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arm Intervention/treatment
Experimental: APC 90W / PPI 120mg
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
Active Comparator: APC 90W / PPI 40mg
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
Active Comparator: APC 60 W/ PPI 120mg
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



Primary Outcome Measures :
  1. Complete ablation rate 6 weeks after APC treatment. [ Time Frame: 6 weeks ]
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands


Secondary Outcome Measures :
  1. Adverse event rate during APC treatment and within 6-week post-treatment period [ Time Frame: 6 weeks ]
  2. Complete ablation rate two years after APC treatment [ Time Frame: 2 years ]
    Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

  3. Complete ablation rate at the end of follow-up [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT04154748    
Other Study ID Numbers: 0102
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

Layout table for additional information
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Barretts Esophagus
Dysplasia
Argon Plasma Coagulation
Endoscopic Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action