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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46043

Enrollment

Registered

2017-12-06

Start date

2018-06-30

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 esophageal cancer

Interventions

Sentinel node navigation surgery followed by lymph node dissection and esophagectomy (standard care) Overview sentinel node navigation surgery: Day before surgery 1. Endoscopic submucosal injection

early esophageal adenocarcinoma

sentinel node procedure

treatment

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Esophageal squamous cell carcinoma - Neo-adjuvant (chemo)radiation therapy - Other primary tumor with a life expectancy

Design outcomes

Primary

Measure	Time frame
- Percentage of patients with a detectable sentinel node, either on SPECT/CT, probe-based and with near-infrared (NIR) camera - Concordance of pre-operative SPECT/CT and perioperative probe-based and indocyanin green (ICG)-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 - Additional yield of ICG-based sentinel node detection over technetium-based sentinel node detection	—

Measure

Time frame

- Percentage of patients with a detectable sentinel node, either on SPECT/CT, probe-based and with near-infrared (NIR) camera - Concordance of pre-operative SPECT/CT and perioperative probe-based and indocyanin green (ICG)-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 - Additional yield of ICG-based sentinel node detection over technetium-based sentinel node detection

—

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)