Sentinel node Navigation surgery in early esophageal Adenocarcinoma Patients with lymph node involvement: SNAP-IV study
- Conditions
- <p>Early esophageal adenocarcinoma with lymph node metastases (T1N1)</p>
- Registration Number
- NL-OMON29572
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Stopped prematurely without inclusion of participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1) EAC clinically staged as T1N1M0 with an indication for esophagectomy, defined as:
a) EAC confined to the mucosa or submucosa on histology (diagnosed in ER specimen), and
b) Suspicion of 1-2 LN metastasis on endoscopic ultrasound, ultrasound of the neck, CT thorax/abdomen and/or PET/CT, and
c) No suspicion of distant metastasis on CT thorax/abdomen and/or PET/CT
2) Fit for endoscopy and surgery per institution’s standards
3) Older than 18 years of age at time of informed consent
4) Willing and able to comply with follow-up requirements
5) Written informed consent
1) History of esophageal squamous cell carcinoma
2) Clinically staged as T>1, N>1 and/or M1
3) Prior neoadjuvant (chemo)radiation therapy
4) Prior esophageal surgery interfering with the procedure
5) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green)
6) Severe medical comorbidities precluding endoscopy and/or surgery
7) Pregnant or planning to become pregnant during period of study
8) Refusing or unable to provide written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of patients in whom tumor-positive lymph nodes are detected as sentinel nodes.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Percentage of patients with a detectable sentinel node. - Number of (tumor-positive) resected sentinel nodes. - Adverse events.</p><br>