Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04154748
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2019-11-05
Brief Title:
Argon Plasma Coagulation for Barretts Esophagus
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Maria Sklodowska-Curie National Research Institute of Oncology
Study Overview
Official Title:
Argon Plasma Coagulation for Barretts Esophagus With Low Grade Dysplasia A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Barretts 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None