Early esophageal adenocarcinoma
Conditions
Interventions
Patients will be subjected to a SN procedure. One day before SN procedure
patients will undergo an upper endoscopy for submucosal injection of the
radioactive tracer (technetium) and indocyanine gre
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Esophageal adenocarcinoma, clinically staged as T1N1M0 with an indication for esophagectomy Clinical condition allowing endoscopy and surgery Older than 18 years at time of informed consent Written informed consent
Exclusion criteria
Exclusion criteria: Esophageal squamous cell carcinoma Clinically staged as T>1, N>1 and/or M1 Neoadjuvant (chemo)radiation therapy Known allergy for the radioactive tracer (technetium) or dye (indocyanine green) Comorbidity precluding endoscopy and/or surgery Refusing or unable to provide written informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes for this study are: 1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based or with a NIR camera. 2) Number of resected SN, location documented. 3) Ratio of number of dissected SNs and number of detected SNs on imaging. 4) Number of tumor-positive dissected SNs, subdivided per LN station. 5) Ratio of number of tumor-positive dissected SNs and number of detected SNs on imaging. 6) Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of SNs. 7) Additional yield of ICG-based SN detection over technetium SN detection. 8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR camera, which could not be dissected during surgery, location and reason documented. 9) Procedure time of SNNS. 10) Incidence and severity of all adverse events. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this study is the percentage of patients in whom tumor-positive LN(s) are detected as SN(s), either on SPECT/CT, probe-based or with a NIR camera. | — |
Countries
Netherlands
Outcome results
None listed