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A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus

A legfontosabb adatok

Ki végzi
University Hospital, Angers
Hol
Franciaország17 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
140 fő, tervezett
Kezdés
2022. márc. 25.
Várható befejezés
2031. júl. 25.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Endorotor
  • Radiofrequency
A regiszteradat frissítve
2026. június 30.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 20 feltétel megnézéseKevesebb

Ki vehet részt

  • Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6)
  • Patients must have signed the consent form in order to participate in the study
  • Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study

Ki nem vehet részt

  • Those with active peptic and/or radiation-induced or complicated esophagitis at the time of treatment
  • Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with invasion of the lateral and/or deep margin, adenocarcinoma of poorly differentiated characteristics or sub-mucosal invasion > 500µm (pT1b)
  • Anticoagulant treatment that cannot be stopped before the intervention (excluding 100 mg maximum per day of aspirin in single-drug treatment) or any haemostasis problems that cannot be corrected
  • Patients incapable of taking proton pump inhibitors (PPIs) orally
  • Individuals who are the subject of psychiatric treatment under duress
  • Presence of a visible lesion that is suspected to be esophageal cancer confirmed by biopsies
  • Presence of esophageal varices or portal hypertension
  • Individuals over 85 years old
  • Women who are pregnant, breastfeeding or in labour
  • Individuals in detention through judicial or administrative decision
  • Individuals who are subjects of legal protection measures
  • Individuals who are in no state to give their consent
  • Individuals who do not understand French or do not know how to read
  • Individuals who are not part of a social security program or benefit from such a scheme
  • All preliminary ablation treatments or dilation for esophageal stenosis
  • Significant esophageal stenosis: cannot be passed with a standard gastroscope
  • Having a contraindication regarding anaesthesia

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.

A teljes eredeti leírásKevesebb

A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

A vizsgálat 2 csoportja

  • EndoRotorA vizsgált kezelés

    The ENDOROTOR is a new system for the resection of superficial lesions within the digestive tract and composed of a reusable generator, a single-use probe and additional accessories. The device is used in the resection of mucosa in the digestive tract: flat or slightly raised lesions in the digestive mucosa, or treatment of the lateral margins following a resection carried out using another technique. Resected tissue is aspirated away through a rotating catheter: the cutting and removal of tissue as well as the collection of specimens are combined into one act.

  • RadiofrequencyMár használt kezelés, összehasonlításként

    Endoscopic treatment using the HALO® 360 or 90 system is a thermal ablation system for superficial mucosa. First and foremost, the examination includes an endoscopy to locate the upper limits of the BE and its distribution, so as to choose the most appropriate type of probe. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia
A regiszteradat frissítve
2026. június 30.