High-risk T1b esophageal adenocarcinoma
Conditions
Interventions
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green (ICG) and near-infrared (NIR) technology.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1) High-risk submucosal EAC on histology (diagnosed in ER specimen) confirmed by an expert gastrointestinal pathologist, defined as: a) Infiltration of EAC into the deep submucosa (>500 µm), and/or; b) Poor differentiation (G3) or undifferentiated (G4) EAC, and/or; c) Presence of lymphovascular invasion 2) Tumor-free deep vertical resection margins in the ER specimen 3) Clinically staged as T1N0M0 4) Fit for endoscopy and surgery per institution’s standards 5) Older than 18 years of age at time of informed consent 6) Willing and able to comply with follow-up requirements 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of esophageal squamous cell carcinoma 2) Clinically staged as N+ 3) Prior neoadjuvant chemoradiation therapy 4) Prior esophageal surgery interfering with the procedure 5) Other primary tumor with a life-expectancy less than 3 years 6) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green) 7) Severe medical comorbidities precluding endoscopy and/or surgery 8) Pregnant or planning to become pregnant during period of study 9) Refusing or unable to provide written informed consent 10) Participation in another study within the 30 days preceding or during the present study, interfering with participation in the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Surgical morbidity, defined as any clinically relevant adverse which is related to sentinel node navigation surgery. - Esophageal and gastric functioning. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of local recurrence, lymph node metastasis and/or distant metastasis after treatment with ER and sentinel node navigation surgery. - Percentage of patients with a detectable sentinel node. - Number of resected sentinel nodes. - Adverse events. - Quality of life. - Surgical mortality, defined as mortality within 30 days after sentinel node navigation surgery. - Disease-free survival. - Overall survival. | — |
Contacts
Public ContactCharlotte Frederiks
University Medical Center Utrecht
Outcome results
None listed