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Radiofrequency in the Treatment of Barrett's Oesophagus (HARMONI)

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ClinicalTrials.gov Identifier: NCT02558504
Recruitment Status : Unknown
Verified October 2015 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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


Condition or disease Intervention/treatment Phase
Esophageal Neoplasm Procedure: Oesophagectomy Device: Radiofrequency ablation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus
Study Start Date : January 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oesophagectomy
While surgical reference technique for invasive cancer of the lower esophagus is the technique according to Lewis Santy, there is no consensus on the technique and surgical approaches lack of specific work in the particular case of superficial lesions . The centers will have the choice of using the technique according to Lewis Santy with gastric plasty or technique of esophagectomy without thoracotomy with lower mediastinal dissection. In the absence of consensus to date available, abdominal surgery time will be by laparotomy or laparoscopy (laparoscopic assisted technique called). In both cases, an exploratory laparoscopy for diagnostic purposes is realized to remove an extension of the disease that would indicate against-resection with curative intent. For surgery, patients will be put under antisecretory therapy proton-pump inhibitor; this at least throughout the duration of the study.
Procedure: Oesophagectomy
Experimental: Radiofrequency ablation

The equipment processing is:

  • The radiofrequency generator,
  • The radiofrequency balloon 360,
  • the radiofrequency probe 90.

The radiofrequency treatment should be carried out according to the following protocol:

  • The radiofrequency treatment is done within 2 months following the last endoscopic assessment.
  • The maximum number of sessions is 4, including 2 maximum with 360 Halo probe.
  • Endoscopy is performed under general anesthesia.
  • The removal must begin at the top 1cm above the upper pole of the lesion and must end 1cm below the lower pole of the lesion.
  • The patient is left fasting until morning. In case of chest pain, the patient may receive analgesics.
  • During the time of treatment, the patient must follow an antisecretory therapy pump inhibitor with dual proton dose orally. The patient should avoid taking aspirin or nonsteroidal anti-inflammatory drugs during the 10 days following each session.
Device: Radiofrequency ablation
Other Name: esophageal radiofrequency




Primary Outcome Measures :
  1. complete histological eradication of the high grade glandular epithelial neoplasia [ Time Frame: 12 months after the end of treatment ]
    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.


Secondary Outcome Measures :
  1. Rate of complete histological eradication of Barret's oesophagus [ Time Frame: 12 months after the end of treatment ]
  2. Rate of mortality all causes merged [ Time Frame: 12 months after the end of treatment ]
  3. Rate of mortality attributable to the procedure [ Time Frame: 30 days after end of the treatment ]
  4. Percentage of patients with severe adverse reaction and minor adverse reactions linked to the procedure used, described by anatomical site [ Time Frame: 30 days and 12 months after end of the treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 mucosa (m2 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558504


Contacts
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Contact: Valérie PLATTNER, MD 0033472406840 valerie.plattner@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Thierry PONCHON, MD         
Contact: Pascale GUERRE    00334 72 11 51 66    pascale.guerre@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02558504     History of Changes
Other Study ID Numbers: 2011-687
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Barrett Esophagus
Esophageal Neoplasms
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms