Radiofrequency Ablation for the Treatment of Gastric Dysplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Francisco Baldaque-Silva, Hospital Sao Joao
ClinicalTrials.gov Identifier:
NCT01523912
First received: January 25, 2012
Last updated: January 29, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gastric Dysplasia
Neoplasia
Device: Radiofrequency ablation of dysplastic mucosa (HALO)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation of Gastric Dysplastic Mucosa by a Novel Endoscopic Radiofrequency Device.

Resource links provided by NLM:


Further study details as provided by Hospital Sao Joao:

Primary Outcome Measures:
  • The % of patients with complete histological clearance of dysplasia. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histological clearance of intestinal metaplasia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse event incidence [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gastric RFA
Ablation of gastric dysplastic mucosa
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.
Other Names:
  • Halo
  • RFA

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523912

Locations
Portugal
Gastroenterology Department, Hospital de Sao Joao
Porto, Portugal
Sponsors and Collaborators
Hospital Sao Joao
Investigators
Principal Investigator: Francisco Baldaque-Silva, MD Hospital Sao Joao
  More Information

No publications provided

Responsible Party: Francisco Baldaque-Silva, Principal Investigator, Hospital Sao Joao
ClinicalTrials.gov Identifier: NCT01523912     History of Changes
Other Study ID Numbers: gastric ablation, SG.HSJ.FMUP.01.2012
Study First Received: January 25, 2012
Last Updated: January 29, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Hospital Sao Joao:
radiofrequency ablation
gastric dysplasia
gastric neoplasia

ClinicalTrials.gov processed this record on October 21, 2014