Barretts Esophagus With Low Grade DysplasiaNCT04154748
Argon Plasma Coagulation for Barrett's Esophagus
A study testing Argon Plasma Coagulation 90W power, Argon Plasma Coagulation 60W power and Omeprazole 120 mg in people with Barretts Esophagus With Low Grade Dysplasia, run by Maria Sklodowska-Curie National Research Institute of Oncology.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With Low Grade Dysplasia
- What is being tested?
- Argon Plasma Coagulation 90W power, Argon Plasma Coagulation 60W power and Omeprazole 120 mg
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2002to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Being tested
- Argon Plasma Coagulation 90W power, Argon Plasma Coagulation 60W power, Omeprazole 120 mg, Omeprazole 40 mg
- Keywords
- Barretts Esophagus, Dysplasia, Argon Plasma Coagulation, Endoscopic Treatment
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Plasma Coagulation 90W powerDevice
Argon Plasma Coagulation 60W powerDevice
Omeprazole 120 mgDrug
Omeprazole 40 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Device: Argon Plasma Coagulation 60W power; Drug: Omeprazole 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
Adverse event rate during APC treatment and within 6-week post-treatment period
Measured: 6 weeks
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
Measured: 2 years
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
Measured: Long term follow-up (>4 yars)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start4 Jun 2002
- Primary completion10 Feb 2015
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barretts Esophagus With Low Grade DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154748
- Sponsor's protocol ID
- 0102
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32650347
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04154748
- Acronym / sponsor ID
- 0102
- Keywords
- Barretts Esophagus, Dysplasia, Argon Plasma Coagulation, Endoscopic Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- 4 Jun 2002 (actual)
- Primary completion
- 10 Feb 2015 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
| Arm | Type | Receives |
|---|---|---|
| APC 90W / PPI 120mg | Experimental | Device: Argon Plasma Coagulation 90W power, Drug: Omeprazole 120 mgtreatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d) |
| APC 90W / PPI 40mg | Active comparator | Device: Argon Plasma Coagulation 90W power, Drug: Omeprazole 40 mgtreatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d) |
| APC 60 W/ PPI 120mg | Active comparator | Device: Argon Plasma Coagulation 60W power, Drug: Omeprazole 120 mgtreatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- high-grade dysplasia or adenocarcinoma,
- visible lesions (nodules, ulcerations) in Barrett's mucosa,
- serious comorbidities and short life expectancy,
- coagulopathy,
- pregnancy or lactation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
3 secondary outcomes
Adverse event rate during APC treatment and within 6-week post-treatment period
Time frame: 6 weeks
Complete ablation rate two years after APC treatment
Time frame: 2 years
Complete ablation rate at the end of follow-up
Time frame: Long term follow-up (>4 yars)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Derived from this study: PubMed 32650347Wronska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Argon Plasma Coagulation 90W power, Argon Plasma Coagulation 60W power and Omeprazole 120 mg in people with Barretts Esophagus With Low Grade Dysplasia, run by Maria Sklodowska-Curie National Research Institute of Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate 6 weeks after APC treatment. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.