early esophageal adenocarcinoma esophageal cancer
Conditions
Interventions
Sentinel node navigation surgery followed by lymph node dissection and
esophagectomy (standard care)
Overview sentinel node navigation surgery:
Day before surgery
1. Endoscopic submucosal injection
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa) - Clinical condition allowing esophagectomy - Signed informed consent
Exclusion criteria
Exclusion criteria: - Esophageal squamous cell carcinoma - Neo-adjuvant (chemo)radiation therapy - Other primary tumor - Known allergy for the radioactive tracer (technetium) or dye (indocyanin green) - Comorbidity interfering with the procedures - Unable to provide signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of patients with a detectable sentinel node, either on SPECT/CT, probe-based and with near-infrared (NIR) camera - Concordance of pre-operative SPECT/CT and perioperative probe-based and indocyanin green (ICG)-based detection of sentinel nodes - Number of resected sentinel nodes, location documented - Number of resected (non-sentinel) lymph nodes, subdivided per lymph node station - Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging - Additional yield of ICG-based sentinel node detection over technetium-based sentinel node detection | — |
Secondary
| Measure | Time frame |
|---|---|
| - Procedure time of sentinel node navigation surgery - Number of tumor-positive lymph nodes, subdivided per lymph node station - Adverse events | — |
Countries
Netherlands
Outcome results
None listed