Early esophageal adenocarcinoma (high-risk T1b esophageal adenocarcinoma)
Conditions
Interventions
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green and near-infrared technology.
Sponsors
St. Antonius Hospital, Nieuwegein
Eligibility
Inclusion criteria
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 3. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Neo-adjuvant (chemo)radiation therapy 2. Other primary tumor with a life-expectancy less than 5 years. 3. Known allergy for the radioactive tracer (technetium) or dye (indocyanine green) 4. Previous esophageal surgery interfering with the procedure 5. Comorbidity interfering with the procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of patients with a detectable sentinel node - Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of sentinel nodes - Number of resected sentinel nodes - Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging - Additional yield of ICG-based SN detection over technetium SN detection | — |
Secondary
| Measure | Time frame |
|---|---|
| - Procedure time of sentinel node navigation surgery - Number of tumor-positive lymph nodes - Number of resected (non-sentinel) lymph nodes - Adverse events | — |
Contacts
Public ContactAnouk Overwater
St. Antonius Hospital and University Medical Center Utrecht
Outcome results
None listed