An endoscopic reassessment by an expert therapeutic endoscopist in patients with a cT2N0M0 esophageal adenocarcinoma, will result in a significant proportion of patients downstaged to a pT1 lesion, thereby avoiding unnecessary esophagectomy if a…
ID
Bron
Verkorte titel
Aandoening
Esophageal Adenocarcinoma (EAC), Esophagectomy, Slokdarmkanker, Endoscopic Ultrasound
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To prospectively evaluate the value of an endoscopic reassessment of patients with an initial diagnosis of a cT2 EAC by an experienced therapeutic endoscopist, followed by ER of the lesion if deemed possible. Expressed as the number of lesions that are downstaged to a T1 lesion after reassessment and endoscopic resection.
Achtergrond van het onderzoek
The current study will prospectively evaluate the value of an endoscopic reassessment of patients with an initial diagnosis of a cT2 esophageal adenocarcinoma by an experienced therapeutic endoscopist, followed by endoscopic resection of the lesion if deemed possible. Expressed as the number of lesions that are downstaged to a T1 lesion after reassessment and endoscopic resection.
Doel van het onderzoek
An endoscopic reassessment by an expert therapeutic endoscopist in patients with a cT2N0M0 esophageal adenocarcinoma, will result in a significant proportion of patients downstaged to a pT1 lesion, thereby avoiding unnecessary esophagectomy if a curative endoscopic resection can be achieved.
Onderzoeksopzet
Time frame: approximately 1 year
Onderzoeksproduct en/of interventie
To study the resectability of an esophageal adenocarcinoma, patients will undergo an endoscopic re-assessment by high resolution endoscopy. This is a standard procedure; no new interventions will be used.
Publiek
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients aged > 18 years, with a biopsy proven esophageal adenocarcinoma, staged as a cT2N0M0 lesion.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Presence of metastasize disease
- Presence of (cytology proven) lymph node metastasis
- Presence of a stenosis, inhibiting the passage of a gastroscope
- Presence of esophageal varices (inhibiting endoscopic resection)
- Known or suspected esophageal perforation
- Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER, or uncorrectable hemostatic disorders.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7181 |
| NTR-old | NTR7371 |
| Ander register | : MEC-2018-1061 |