Sentinel node Navigation surgery in early esophageal adenocarcinoma Patients
Completed
- Conditions
- Early esophageal adenocarcinoma (high-risk T1b esophageal adenocarcinoma)
- Registration Number
- NL-OMON25123
- Lead Sponsor
- St. Antonius Hospital, Nieuwegein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
1. Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa) with an indication for esophagectomy
2. Clinical condition allowing esophagectomy
Exclusion Criteria
1. Neo-adjuvant (chemo)radiation therapy
2. Other primary tumor with a life-expectancy less than 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Percentage of patients with a detectable sentinel node<br /><br>- Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of sentinel nodes<br /><br>- Number of resected sentinel nodes<br /><br>- Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging<br /><br>- Additional yield of ICG-based SN detection over technetium SN detection
- Secondary Outcome Measures
Name Time Method - Procedure time of sentinel node navigation surgery <br /><br>- Number of tumor-positive lymph nodes<br /><br>- Number of resected (non-sentinel) lymph nodes<br /><br>- Adverse events