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New balloon treatment may replace surgery for early esophageal cancer

NCT ID NCT02558504

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two treatments for early-stage esophageal cancer in people with Barrett's esophagus: a new, less invasive procedure using radiofrequency ablation (a balloon that burns away abnormal cells) versus standard surgery to remove part of the esophagus. The goal was to see if the ablation could completely eliminate the cancer with fewer risks. The study involved 87 adults who were healthy enough for either treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

87 people

The number who actually took part.

Started

Jan 2013

Finished

Jan 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Lyon, 69003, France

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Other studies related to the condition(s) this trial covers.