Radiofrequency in the Treatment of Barrett's Oesophagus

Esophageal Neoplasm Clinical Trial

— HARMONI  

Official title:

Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558504
• Other study ID #: 2011-687
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2013
• Est. completion date: January 18, 2021

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%). Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years,
• General Condition WHO 0, 1 or 2,
• ASA Class I and II, eligible for endoscopic or surgical treatment with curative intent,
• Histological diagnosis of high grade glandular epithelial neoplasia (Vienna 4-1 to 4-46), possibly multifocal or stage 0 (Tis, N0, M0),
• Endoscopic and histological confirmed diagnosis of intestinal metaplasia,
• Histological diagnosis confirmed by two endoscopies with biopsies and two pathological readings; biopsies should be carried out according to the protocol of the SFED (four-quadrant biopsies every cm) with at least once acetic acid for staining. Operators describe Barrett's esophagus using he SFED planimetric model. The final exam will be no more than two months before the date of treatment and should have been achieved in investigator establishment,
• Extension height of Barrett's esophagus upstream of the upper part of the gastric

folds or palisade vessels:

• Minimum 1 cm,
• Maximum 12 cm.
• In case of previous treatment by mucosal resection or submucosal dissection (DSM) for

severe dysplasia or microinvasive carcinoma:

• the resected lesion must have been well differentiated and confined to the muscular mucosa (m3 maximum) on histological analysis,
• resection should be more than two months,
• resection must have been macroscopically complete laterally,
• resection must have been histologically complete in depth,
• resection must have been histologically complete laterally with regard to the microinvasive cancer, that is to say with a clear margin of safety (margin may be high-grade dysplasia provided that the latter has not macroscopic translation),
• At least one endoscopic and histologic follow-up should be conducted with dye in a period of less than two months before the date of treatment, and at the investigator establishment.
• Patient may take an inhibitor of proton pump equivalent to 2 times 40 mg of esomeprazole,
• No mediastinal or celiac, or suspected metastatic lymph nodes by EUS,
• Affiliation to a social security system or similar,
• Lack of participation in another clinical study,
• Informed consent signed.

Exclusion Criteria:

• - Aged under 18,
• Lack of informed consent signed,
• Radiofrequency treatment history,
• on going neoplastic history with a short prognosis,
• Concomitant participation in another clinical study
• Contraindication to general anesthesia,
• Patient with an esophageal location of scleroderma
• Presence of a cardiac pacemaker or stimulator
• Pregnant women or likely to be in the absence of effective contraception,
• Esophageal stenosis preventing the passage of an endoscope,
• Histology other than glandular neoplasia,
• History of or current history of esophageal cancer invading the submucosal layer of the esophagus or more,
• Surgical treatment history (except anti-reflux treatment) or esophageal radiotherapy,
• previous esophageal treatment by another method ablation: photodynamic therapy, argon plasma coagulation, laser, ....
• Esophageal varices observed in endoscopy,
• Coagulopathy or taking anticoagulants responsible an INR> 1.3 or a platelet count <75,000 per microL,
• Life expectancy of less than 3 years, due to intercurrent disease, especially neoplastic,
• Severe Medical pathology:
• Liver cirrhosis (Child-Pugh all stages)
• Respiratory failure:

VEMS (Maximum Expiratory Volume Second) <1L / min PaO2 <60 mmHg PaCO2> 45 mmHg

• Renal failure (Cl Cr < 60 mL /min /1,73m²),
• Heart attack within the last six months or progressive coronary artery disease,
• Severe distal arteriopathie > stage II of Leriche and Fontaine

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Procedure:
• Oesophagectomy

Device:
• Radiofrequency ablation

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete histological eradication of the high grade glandular epithelial neoplasia	The rate of success of the technique, success being defined as the complete histological eradication of the high grade glandular epithelial neoplasia without death attributable to the procedure. The relation of a death to the procedure will be determined by a committee of experts consisting of 3 surgeons or 3 hepatogastroenterologists depending on the arm, who do not participate to the study.	12 months after the end of treatment
Secondary	Rate of complete histological eradication of Barret's oesophagus		12 months after the end of treatment
Secondary	Rate of mortality all causes merged		12 months after the end of treatment
Secondary	Rate of mortality attributable to the procedure		30 days after end of the treatment
Secondary	Percentage of patients with severe adverse reaction and minor adverse reactions linked to the procedure used, described by anatomical site		30 days and 12 months after end of the treatment