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NCT04154748
Argon Plasma Coagulation for Barrett's Esophagus
NA trial testing Argon Plasma Coagulation 90W power in Barretts Esophagus With Low Grade Dysplasia in 71 participants. Completed in 5 July 2019.
10 February 2015
Quick facts
| Lead sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 4 June 2002 |
| Primary completion | 10 February 2015 |
| Estimated completion | 5 July 2019 |
Drugs / interventions tested
- Argon Plasma Coagulation 90W power
- Argon Plasma Coagulation 60W power
- Omeprazole 120 mg — full drug profile →
- Omeprazole 40 mg — full drug profile →
Conditions studied
- Barretts Esophagus With Low Grade Dysplasia — all drugs for Barretts Esophagus With Low Grade Dysplasia →
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Who can join
18 and older, any sex, with Barretts Esophagus With Low Grade Dysplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04154748
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04154748 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maria Sklodowska-Curie National Research Institute of Oncology
- Last refreshed: 19 November 2019
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