Trial | NCT04154748  Report issue

Title

Argon Plasma Coagulation for Barrett's Esophagus
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
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 Started
Jun 04
2002
Primary Completion
Feb 10
2015
Study Completion
Jul 05
2019
Last Update
Nov 19
2019

Device Argon Plasma Coagulation 90W power

Device Argon Plasma Coagulation 60W power

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)

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)

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)

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.
No Results Posted