Sentinel node procedure in early esophageal carcinoma patients with suspicion of lymph node metastases

Phase 1

• Conditions: Esophageal adenocarcinoma; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2020-000878-15-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1) Esophageal adenocarcinoma, clinically staged as T1N1M0 with an indication for esophagectomy
2) Fit for endoscopy and surgery per institution’s standards
3) Older than 18 years of age at time of informed consent
4) Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Validation of the accuracy of sentinel node navigation surgery (SNNS) for the detection of tumor-positive lymph nodes in patients with T1 esophageal adenocarcinoma and lymph node metastases. <br>;Secondary Objective: To introduce an esophageal preserving treatment regimen for high-risk T1b esophageal adenocarcinoma patients. ;Primary end point(s): Percentage of patients in whom tumor-positive LN(s) are detected as SN(s); defined as the number of patients with 1 or more tumor-positive LNs detected as SNs, reported separately per type of detection (SPECT/CT, probe-based or NIR camera).;Timepoint(s) of evaluation of this end point: After histopathological assessment of surgical resection specimens (lymph nodes and esophagus).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based or with a NIR camera.<br>2) Number of resected SN, location documented. <br>3) Ratio of number of dissected SNs and number of detected SNs on imaging.<br>4) Number of tumor-positive dissected SNs, subdivided per LN station.<br>5) Ratio of number of tumor-positive dissected SNs and number of detected SNs on imaging.<br>6) Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of SNs.<br>7) Additional yield of ICG-based SN detection over technetium SN detection.<br>8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR camera, which could not be dissected during surgery, location and reason documented.<br>9) Procedure time of SNNS.<br>10) Incidence and severity of all adverse events.;Timepoint(s) of evaluation of this end point: After surgical procedure and histopathological assessment of surgical resection specimens (lymph nodes and esophagus).