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Esophageal NeoplasmPhase 4HARMONINCT02558504

Radiofrequency in the Treatment of Barrett's Oesophagus

A Phase 4 study testing Oesophagectomy and Radiofrequency ablation in people with Esophageal Neoplasm, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Neoplasm
What is being tested?
Oesophagectomy and Radiofrequency ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteFrance
Study dates
7 Jan 2013to 18 Jan 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • - 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,
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot

    Lyon, 69003

Other trials in France

About this study

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

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

Being tested
Oesophagectomy, Radiofrequency ablation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OesophagectomyProcedure or surgery

  • Radiofrequency ablationDevice

    Also called esophageal radiofrequency

Study groups in NCT02558504
Study groupRoleWhat they receive
OesophagectomyActive comparatorWhile 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.
Receives: Procedure: Oesophagectomy
Radiofrequency ablationExperimentalThe 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.
Receives: Device: Radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months after the end of treatment

Secondary outcomes (4)

  1. Rate of complete histological eradication of Barret's oesophagus

    Measured: 12 months after the end of treatment

  2. Rate of mortality all causes merged

    Measured: 12 months after the end of treatment

  3. Rate of mortality attributable to the procedure

    Measured: 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

    Measured: 30 days and 12 months after end of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study start7 Jan 2013
  3. Primary completion18 Jan 2021
  4. Study completion18 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558504
Sponsor's protocol ID
2011-687
Acronym
HARMONI
Status last verified
Sep 2025
First submitted
23 Sep 2015
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.

    PubMed 33685969

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oesophagectomy and Radiofrequency ablation in people with Esophageal Neoplasm, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete histological eradication of the high grade glandular epithelial neoplasia (time frame: 12 months after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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