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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20041
Enrollment
5
Registered
2015-06-09
Start date
2015-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early esophageal adenocarcinoma vroege slokdarmkanker

Interventions

sentinel node procedure, followed by esophagectomy and gastric tube reconstruction

Sponsors

Academic Medical Center Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Esophageal squamous cell carcinoma - Neo-adjuvant (chemo)radiation therapy - other primary tumor - Known allergy for the radioactive tracer (technetium) - Previous esophageal surgery interfering with the procedure - Comorbidity interfering with the procedures - Unable to provide signed informed consent

Design outcomes

Primary

MeasureTime frame
- Percentage of patients with a detectable sentinel node, either on SPECT/CT or probe-based - Concordance of pre-operative SPECT/CT and perioperative probe-based detection of sentinel nodes - Number of resected sentinel nodes, location documented - Number of resected (non-sentinel) lymph nodes, subdivided per lymph node station - Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging

Secondary

MeasureTime frame
- Procedure time of sentinel node navigation surgery - Number of tumor-positive lymph nodes, subdivided per lymph node station - Adverse events

Contacts

Public ContactH. Künzli

Meiberdreef 9

h.t.kunzli@amc.uva.nl020-5665584

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)