Sentinel node Navigation surgery in early esophageal Adenocarcinoma Patients: the SNAP-II study
Completed
- Conditions
- early esophageal adenocarcinomaesophageal cancer10017990
- Registration Number
- NL-OMON46043
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
- Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa) with an indication for esophagectomy - Clinical condition allowing esophagectomy - Signed informed consent
Exclusion Criteria
- Esophageal squamous cell carcinoma - Neo-adjuvant (chemo)radiation therapy - Other primary tumor with a life expectancy < 5 years - Known allergy for the radioactive tracer (technetium) or dye (indocyanin green) - Comorbidity interfering with the procedures - Unable to provide signed informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Percentage of patients with a detectable sentinel node, either on SPECT/CT,<br /><br>probe-based and with near-infrared (NIR) camera - Concordance of pre-operative<br /><br>SPECT/CT and perioperative probe-based and indocyanin green (ICG)-based<br /><br>detection of sentinel nodes - Number of resected sentinel nodes, location<br /><br>documented - Number of resected (non-sentinel) lymph nodes, subdivided per<br /><br>lymph node station - Ratio of number of dissected sentinel nodes and number of<br /><br>detected sentinel nodes on imaging - Additional yield of ICG-based sentinel<br /><br>node detection over technetium-based sentinel node detection </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Procedure time of sentinel node navigation surgery - Number of tumor-positive<br /><br>lymph nodes, subdivided per lymph node station - Adverse events </p><br>