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

Phase 4
18 Years
Open (Enrolling)
Gastric Dysplasia, Neoplasia

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

The % of patients with complete histological clearance of dysplasia.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Francisco Baldaque-Silva, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Sao Joao


Portugal: Ethics Committee for Clinical Research

Study ID:

gastric ablation



Start Date:

January 2011

Completion Date:

May 2016

Related Keywords:

  • Gastric Dysplasia
  • Neoplasia
  • radiofrequency ablation
  • gastric dysplasia
  • gastric neoplasia
  • Neoplasms