Endoscopic management of patients with high risk T1a and T1b N0M0 esophageal adenocarcinoma: a prospective multicenter registry
Recruiting
- Conditions
- esophageal cancer10017990
- Registration Number
- NL-OMON54809
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 175
Inclusion Criteria
1. Patients with high risk mucosal or submucosal EAC diagnosed in an ER
specimen, diagnosed by an expert gastrointestinal (GI) pathologist.
2. Signed informed consent.
Exclusion Criteria
1. Prior history of esophageal cancer (invasion of T1sm or deeper or HR T1a).
2. Synchronous esophageal squamous cell carcinoma
3. Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound
of the neck, CT-thorax-abdomen or PET-CT during baseline measurement.
4. Tumor-positive deep resection margin (R1) in ER/ESD specimen
5. Patients unable to give signed informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1.5-year disease-specific mortality/survival<br /><br>2.Overall survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Lymph node metastasis, confirmed by cytology and and/or histology .<br /><br>2. Local recurrence eligible for endoscopic therapy<br /><br>3. Local recurrence requiring surgical therapy<br /><br>4. Distant metastasis, histopathologically and/or cytologically proven.<br /><br>5. Quality of life</p><br>