NL-OMON25137
Completed
Not Applicable
Tailored lymphadenectomy using Sentinel node Navigation surgery in submucosal esophageal Adenocarcinoma Patients: SNAP-III study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- <p>High-risk T1b esophageal adenocarcinoma</p>
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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