Endoscopic ablation of dysplastic Barrett’s oesophagus

• Register: ANZCTR
• Last refreshed on: 5 January 2021
• Main ID: ACTRN12617000402347
• Date of registration: 17/03/2017
• Prospective Registration: Yes
• Primary sponsor: Royal Prince Alfred Hospital
• Public title: Endoscopic ablation of dysplastic Barrett’s oesophagus
• Scientific title: Endoscopic ablation of dysplastic Barrett’s oesophagus
• Date of first enrolment: 22/06/2017
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617000402347.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Payal Saxena

• Name: Dr Payal Saxena

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Oesophageal (gullet)

Barrett's oesophagus;oesophageal cancer;
Barrett's oesophagus
oesophageal cancer

Intervention(s)

Therapeutic intervention for patients with dysplastic barrett's oesophagus or early oesophageal cancer. Patients will undergo hybrid-Argon plasma coagulation during gastroscopy to ablate the dysplastic tissue. This will involve removal of visible lesions of Barrett’s Oesophagus that will be confirmed by microscopic assessment as part of clinical care. During the gastroscopy a salt-water solution will be injected into the submucosa of the oesophageal wall and thereafter the affected area will be treated with Argon Plasma Coagulation.

The procedure will be performed by dr Saxena, who is a highly qualified gastroenterologist and specialized in the treatment of barretts oesophagus. The procedure will approximately take 30 minutes. Thereafter patients will be followed during a follow-up period of 5 years.

Primary Outcome(s)

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.

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.

]

Secondary Outcome(s)

To assess cost per patient of HAPC for the removal of residual BO. The costs will be assessed based on the costs of equipment that is used, the costs for the procedure, and the costs of complications assessed from hospital medical records.[5 years follow-up post initial ablation procedure]

The total number of procedures carried out with Hybrid Argon Plasma Coagulation (HAPC) per participant.
It is a prospective trial with a follow-up of 5 years. Review of medical records will be used during follow-up period. [5 year follow-up post initial ablation procedure.]

To assess the rates of minor and major complications in patients undergoing HAPC for the treatment of dysplastic Barretts Oesophagus '(BO). This is a composite secondary outcome.
a. Minor complications include pain, dysphagia, gastrointestinal bleeding without need for blood transfusion and a significant drop in hemoglobin (Hb < 2 g/dl), and fever during the first 24 hours.
b. Major complications include strictures that cause dysphagia and require dilatation, perforation, gastrointestinal bleeding with a drop of hemoglobin values (Hb > 2 g/dl) or requiring transfusion and fever persisting for more than 24 hours.

The outcomes will be assessed by the patient charts and questions during follow-up visit[5 years follow-up post initial ablation procedure]

To determine the recurrence rates of dysplasia and IM with HAPC. This will be assessed during follow-up by taking biopsies.[5 years follow-up post initial ablation procedure]

Secondary ID(s)

nil

Source(s) of Monetary Support

Royal Prince Alfred Hospital

Ethics review

Status: Approved
Approval date: 15/05/2017
Contact:

Ethics Review Committee Royal Prince Alfred hospital