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Completed

NCT Number: NCT01523912

Radiofrequency Ablation for the Treatment of Gastric Dysplasia

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.

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Key information

Conditions

Gastric Dysplasia Neoplasia Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastroenterology Department, Hospital de Sao Joao

Porto, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological confirmation of gastric dysplasia.
  • The lesion is no larger than 5 cm in diameter.
  • Age ≥ 18 years.
  • Subject is able to tolerate endoscopy and sedation.
  • Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion criteria

  • Prior gastric irradiation or surgery.
  • Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
  • Gastric ulcers, fistulae, varices and malignancy.
  • History of alcohol and/or controlled substance dependency.
  • Pregnancy.

Treatment and study plan

Radiofrequency ablation of dysplastic mucosa (HALO)

Device

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.

Other names: Halo, RFA

Primary outcomes

  1. The % of patients with complete histological clearance of dysplasia.

    Time frame: 12 months

Secondary outcomes

  1. Histological clearance of intestinal metaplasia

    Time frame: 12 months

  2. Adverse event incidence

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Hospital Sao Joao

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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