Sentinel node Navigation surgery in early esophageal Adenocarcinoma Patients with lymph node involvement: SNAP-IV study

Withdrawn

• Conditions: early esophageal cancer; Early esophageal adenocarcinoma; 10017990

• Registration Number: NL-OMON50168
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Esophageal adenocarcinoma, clinically staged as T1N1M0 with an indication for
esophagectomy
Clinical condition allowing endoscopy and surgery
Older than 18 years at time of informed consent
Written informed consent

Exclusion Criteria

Esophageal squamous cell carcinoma
Clinically staged as T>1, N>1 and/or M1
Neoadjuvant (chemo)radiation therapy
Known allergy for the radioactive tracer (technetium) or dye (indocyanine
green)
Comorbidity precluding endoscopy and/or surgery
Refusing or unable to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome for this study is the percentage of patients in whom<br /><br>tumor-positive LN(s) are detected as SN(s), either on SPECT/CT, probe-based or<br /><br>with a NIR camera. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes for this study are:<br /><br>1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based<br /><br>or with a NIR camera.<br /><br>2) Number of resected SN, location documented.<br /><br>3) Ratio of number of dissected SNs and number of detected SNs on imaging.<br /><br>4) Number of tumor-positive dissected SNs, subdivided per LN station.<br /><br>5) Ratio of number of tumor-positive dissected SNs and number of detected SNs<br /><br>on imaging.<br /><br>6) Concordance of pre-operative SPECT/CT and perioperative probe-based and<br /><br>ICG-based detection of SNs.<br /><br>7) Additional yield of ICG-based SN detection over technetium SN detection.<br /><br>8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR<br /><br>camera, which could not be dissected during surgery, location and reason<br /><br>documented.<br /><br>9) Procedure time of SNNS.<br /><br>10) Incidence and severity of all adverse events. </p><br>