Endoscopic ablation of dysplastic Barrett’s oesophagus

Not Applicable

Recruiting

• Conditions: Barrett's oesophagus; oesophageal cancer; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12617000402347
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-17
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma

Exclusion Criteria

a)C value greater than 6 cm using the Prague criteria
b)Prior ER for adenocarcinoma with histological diagnosis of greater than or equal to T1b;
c)Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional endoscopic resection is allowed);
d)Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial HAPC treatment without endoscopic resection of cancer lesion for staging;
e)Pregnancy
f)Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated;
g)Patients with incomplete healing post-endoscopic resection despite adequate PPI-medication;
h)Prior ablative therapy in the oesophagus;
i)Significant oesophageal stenosis prior to initial HAPC treatment defined as a stenosis that cannot be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before.
j)Presence of esophageal varices
k)Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to HAPC or incorrectable hemostatic disorders
l)Life expectancy less than 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission of barrett's neoplasia and metaplasia. This will be assessed by taking biopsies during follow-up.[The primary timepjoint is one year after treatment.<br><br>Patients undergo endoscopic follow-up after treatment at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months in which biospies will be obtained to review any recurrence of dysplasia. <br><br>]