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Diagnostic and therapeutic implications of endoscopic resection in EUS-staged T2 esophageal adenocarcinoma

Diagnostic and therapeutic implications of endoscopic resection in EUS-staged T2 esophageal adenocarcinoma: a prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26531
Enrollment
40
Registered
2018-07-18
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Adenocarcinoma (EAC), Esophagectomy, Slokdarmkanker, Endoscopic Ultrasound

Interventions

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.

Sponsors

Erasmus Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged > 18 years, with a biopsy proven esophageal adenocarcinoma, staged as a cT2N0M0 lesion.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To prospectively evaluate the number of lesions that are within currently accepted criteria for endoscopic resection

Contacts

Public ContactSteffi van de Ven

Gastroenterology and Hepatology department P.O. Box 2040

s.vandeven@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)