Radiofrequency Ablation for the Treatment of Gastric Dysplasia

Gastric Dysplasia Clinical Trial

Official title:

Ablation of Gastric Dysplastic Mucosa by a Novel Endoscopic Radiofrequency Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523912
• Other study ID #: gastric ablation
• Secondary ID: SG.HSJ.FMUP.01.2
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2012
• Last updated: February 18, 2016
• Start date: January 2011
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial Summary

The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.

Description:

Gastric cancer is the fourth most common cancer and the second leading cause of cancer related death worldwide. The 10-year survival of patients with this malignancy is 20% due to advanced disease at the time of diagnosis. Screening programs in countries with a high incidence of gastric neoplasia aim to detect early stage cancer, suitable for curative treatment. Well-differentiated dysplastic gastric lesions limited to the mucosa (when non-ulcerated or ulcerated and less than 3 cm) or limited to the superficial submucosa (when less than 3 cm and with no lymphatic or vascular invasion) have a negligible risk of lymph node metastasis and are suitable for endoscopic curative treatment.

Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have been increasingly used in this setting with promising results. However, even with these advanced techniques, en bloc and R0 resection is not possible in up to 13-15% and 16-26% of the cases, respectively. The presence of dysplasia after endoscopic resection (DAER) in the post-resection scar presents a challenging dilemma due to the technical difficulty, and associated complications, of performing subsequent EMR/ESD in fibrotic tissue. Another issue of concern is the presence of gastric dysplasia not associated with macroscopic lesions (DNAML). In such cases, a targeted endoscopic treatment is difficult and clinical management is not standardized.

Radiofrequency ablation (RFA) has been increasingly advocated for the treatment of dysplastic Barrett's esophagus (BE) and early esophageal squamous cell carcinoma (ESCC), but its use in gastric dysplasia has not yet been tested. The investigators aim to study the role of gastric RFA in the treatment of DNAML and DAER.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histological confirmation of gastric dysplasia.

2. The lesion is no larger than 5 cm in diameter.

3. Age = 18 years.

4. Subject is able to tolerate endoscopy and sedation.

5. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion Criteria:

1. Prior gastric irradiation or surgery.

2. Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.

3. Gastric ulcers, fistulae, varices and malignancy.

4. History of alcohol and/or controlled substance dependency.

5. Pregnancy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Dysplasia
• Neoplasia

Intervention

Device:
• Radiofrequency ablation of dysplastic mucosa (HALO)
Gastric ablation is performed using the HALO Ablation System (BÂRRX Medical Inc., Sunnyvale, CA, USA). A HALO90 ablation catheter, which is mounted on the tip of an endoscope, is used. Radiofrequency energy is delivered at 40 W/cm2 and 15 J/cm2 via a 13 x 20 mm electrode. All patients will have two RFA sessions 8 weeks apart with the same area being ablated in consecutive endoscopies. The precise area to ablated in the second RFA session is determined by referring to careful measurements that utilized gastric landmarks (a typical notation may specify that the lesion extends from 2 to 5 cm proximal of the pylorus in the 5 o'clock position and is 4 cm wide) as well as to digital image recordings that are taken during the first RFA.

Locations

Country	Name	City	State
Portugal	Gastroenterology Department, Hospital de Sao Joao	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The % of patients with complete histological clearance of dysplasia.		12 months	No
Secondary	Histological clearance of intestinal metaplasia		12 months	No
Secondary	Adverse event incidence		60 days	Yes