We hypothesize that MBM may have significant advantages over the ER-cap technique, especially in countries where endoscopic expertise is limited. The aim of this study was to assess the feasibility, safety and effectiveness of the MBM technique…
ID
Bron
Aandoening
esophageal squamous cell neoplasia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The percentage of subjects with complete endoscopic removal of the qualifying lesion including pre-randomisation markers at the first ER section;<br>
2. The percentage of subjects with no HGIN or ESCCA in biopsies obtained within 1-cm of the ER scar at 3 months follow-up.
Achtergrond van het onderzoek
Endoscopic Resection (ER) for oesophageal highgrade intraepithelial neoplasia (HGIN) or intramucosal cancer (OSCC) with the ER-cap technique is technically difficult, requires submucosal lifting and multiple snares for piecemeal resections. Multi Band Mucosectomy (MBM) is an easy-to-use ER-technique and may be the modality of choice in China, where OSCC is extremely prevalent. We hypothesize that ER-cap and MBM will be equally effective and safe for piecemeal ER in selected patients. Piecemeal ER using the ER-cap, however, is technically more difficult and requires a higher number of disposables. We, therefore, hypothesize that MBM for piecemeal ER will reduce procedure time and cost significantly compared to ER-cap. From a clinical perspective MBM would be a valid alternative to ER-cap if a significant reduction of procedure time and cost were found while maintaining a success rate that is comparable to the ER-cap technique.
Patients with HGIN/OSCC and no signs of submucosal invasion or metastatic disease will be included. Lesions are delineated with electrocoagulation and resected with MBM or ER-Cap.
Doel van het onderzoek
We hypothesize that MBM may have significant advantages over the ER-cap technique, especially in countries where endoscopic expertise is limited.
The aim of this study was to assess the feasibility, safety and effectiveness of the MBM technique for piece-meal ER of early mucosal squamous cell neoplasia of the oesophagus and to randomly compare the MBM technique to the ER-cap technique.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Endoscopic resection of early esophageal neoplastic lesions by either MBM or ER-cap technique.
Publiek
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
Wetenschappelijk
David Boerwinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664571
d.f.boerwinkel@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Subject is 18-85 years of age, inclusive;
2. A lesion in the squamous esophagus that is visible with white light endoscopy and contains a type 0-IIa, 0-IIb and/or 0-IIc component;
3. After Lugol’s staining the lesion and surrounding USLs (i.e. the treatment area; TA) measures ≥2cm and ≤6cm and encompasses ≤2/3 of the circumference;
4. A histological diagnosis of HGIN or ESCCA in biopsies obtained anywhere from the TA;
5. No infiltration into the submucosa or beyond or metastatic disease on endoscopic ultrasound (EUS) and CT-scan of thorax and upper third of the abdomen;
6. Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol;
7. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Any type 0-I or 0-III lesion in the esophagus;
2. Any other neoplastic lesion in the squamous esophagus that is visible with white light endoscopy and can not be included in the TA to meet its maximum size requirements;
3. Any unstained lesion after Lugol’s staining elsewhere in the esophagus that can not be included in the TA to meet the its maximum size requirements and contains HGIN or ESCC upon biopsy;
4. Any N or M positive status;
5. Any prior endoscopic resection or endoscopic ablation therapy of the esophagus within a 3 cm range of the TA;
6. Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 12 months before screening for this trial;
7. Any prior radiation therapy to the esophagus;
8. Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc).
Opzet
Deelname
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