Sentinel node Navigation surgery in early esophageal Adenocarcinoma Patients: the SNAP study

Completed

• Conditions: early esophageal adenocarcinoma; esophageal cancer; 10017990

• Registration Number: NL-OMON44799
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa)
- Clinical condition allowing esophagectomy
- Signed informed consent

Exclusion Criteria

- Esophageal squamous cell carcinoma
- Neo-adjuvant (chemo)radiation therapy
- Other primary tumor
- Known allergy for the radioactive tracer (technetium) or dye (indocyanin green)
- Comorbidity interfering with the procedures
- Unable to provide signed informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Percentage of patients with a detectable sentinel node, either on SPECT/CT,<br /><br>probe-based and with near-infrared (NIR) camera<br /><br>- Concordance of pre-operative SPECT/CT and perioperative probe-based and<br /><br>indocyanin green (ICG)-based detection of sentinel nodes<br /><br>- Number of resected sentinel nodes, location documented<br /><br>- Number of resected (non-sentinel) lymph nodes, subdivided per lymph node<br /><br>station<br /><br>- Ratio of number of dissected sentinel nodes and number of detected sentinel<br /><br>nodes on imaging<br /><br>- Additional yield of ICG-based sentinel node detection over technetium-based<br /><br>sentinel node detection</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Procedure time of sentinel node navigation surgery<br /><br>- Number of tumor-positive lymph nodes, subdivided per lymph node station<br /><br>- Adverse events</p><br>