No registrations found.
ID
Source
Brief title
Health condition
Esophageal Adenocarcinoma (EAC), Esophagectomy, Slokdarmkanker, Endoscopic Ultrasound
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
To prospectively evaluate the number of lesions that are within currently accepted criteria for endoscopic resection
Background summary
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.
Study objective
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.
Study design
Time frame: approximately 1 year
Intervention
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.
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
Inclusion criteria
Patients aged > 18 years, with a biopsy proven esophageal adenocarcinoma, staged as a cT2N0M0 lesion.
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7181 |
| NTR-old | NTR7371 |
| Other | : MEC-2018-1061 |