Sentinel node navigation surgery in early esophageal adenocarcinoma is feasible and safe.
ID
Bron
Verkorte titel
Aandoening
Early esophageal adenocarcinoma (high-risk T1b esophageal adenocarcinoma)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Percentage of patients with a detectable sentinel node<br>
- Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of sentinel nodes<br>
- Number of resected sentinel nodes<br>
- Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging<br>
- Additional yield of ICG-based SN detection over technetium SN detection
Achtergrond van het onderzoek
The objective of this study is to evaluate the feasibility, accuracy and safety of a sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green (ICG) and near-infrared (NIR) technology in patients with high-risk T1b esophageal adenocarcinoma.
Doel van het onderzoek
Sentinel node navigation surgery in early esophageal adenocarcinoma is feasible and safe.
Onderzoeksopzet
- Post-procedure follow-up until 30 days after surgery
Onderzoeksproduct en/of interventie
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green and near-infrared technology.
Publiek
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Wetenschappelijk
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa) with an indication for esophagectomy
2. Clinical condition allowing esophagectomy
3. Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Neo-adjuvant (chemo)radiation therapy
2. Other primary tumor with a life-expectancy less than 5 years.
3. Known allergy for the radioactive tracer (technetium) or dye (indocyanine green)
4. Previous esophageal surgery interfering with the procedure
5. Comorbidity interfering with the procedures
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7167 |
| NTR-old | NTR7390 |
| Ander register | MEC-U : R17.028 |