No registrations found.
ID
Source
Brief title
Health condition
Early esophageal adenocarcinoma (high-risk T1b esophageal adenocarcinoma)
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage of patients with a detectable sentinel node
- Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of sentinel nodes
- Number of resected sentinel nodes
- Ratio of number of dissected sentinel nodes and number of detected sentinel nodes on imaging
- Additional yield of ICG-based SN detection over technetium SN detection
Secondary outcome
- Procedure time of sentinel node navigation surgery
- Number of tumor-positive lymph nodes
- Number of resected (non-sentinel) lymph nodes
- Adverse events
Background summary
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.
Study objective
Sentinel node navigation surgery in early esophageal adenocarcinoma is feasible and safe.
Study design
- Post-procedure follow-up until 30 days after surgery
Intervention
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green and near-infrared technology.
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7167 |
| NTR-old | NTR7390 |
| Other | MEC-U : R17.028 |