Tailored lymphadenectomy using Sentinel node Navigation surgery in submucosal esophageal Adenocarcinoma Patients: SNAP-III study
- Conditions
- <p>High-risk T1b esophageal adenocarcinoma</p>
- Registration Number
- NL-OMON25137
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method