Tumor-positive lymph nodes in patients with early EAC can be accurately detected through a sentinel node procedure.
ID
Source
Brief title
Health condition
Early esophageal adenocarcinoma with lymph node metastases (T1N1)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients in whom tumor-positive lymph nodes are detected as sentinel nodes.
Secondary outcome
- Percentage of patients with a detectable sentinel node. - Number of (tumor-positive) resected sentinel nodes. - Adverse events.
Background summary
High-risk T1b esophageal adenocarcinoma (EAC) is currently treated with esophagectomy with lymph node dissection given the high rates of lymph node metastases (16-41%). However, recent studies reporting on patients after endoscopic resection (ER) of T1b EAC suggest a much lower risk of LN metastasis. Esophagectomy is associated with substantial morbidity (up to 45%) and mortality (2-4%). Recently, our study group stepwise investigated a treatment strategy comprising a sentinel node procedure to identify patients with low risk of lymph node metastasis to spare these patients an unnecessary esophagectomy. The objective of this study is to validate the accuracy of sentinel node navigation surgery using lymphoscintigraphy with radioactive tracer and near-infrared technology with indocyanine green for the detection of tumor-positive lymph nodes.
Study objective
Tumor-positive lymph nodes in patients with early EAC can be accurately detected through a sentinel node procedure.
Study design
Follow-up until sentinel node procedure.
Intervention
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green and near-infrared technology.
Inclusion criteria
1) EAC clinically staged as T1N1M0 with an indication for esophagectomy, defined as: a) EAC confined to the mucosa or submucosa on histology (diagnosed in ER specimen), and b) Suspicion of 1-2 LN metastasis on endoscopic ultrasound, ultrasound of the neck, CT thorax/abdomen and/or PET/CT, and c) No suspicion of distant metastasis on CT thorax/abdomen and/or PET/CT 2) Fit for endoscopy and surgery per institution’s standards 3) Older than 18 years of age at time of informed consent 4) Willing and able to comply with follow-up requirements 5) Written informed consent
Exclusion criteria
1) History of esophageal squamous cell carcinoma 2) Clinically staged as T>1, N>1 and/or M1 3) Prior neoadjuvant (chemo)radiation therapy 4) Prior esophageal surgery interfering with the procedure 5) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green) 6) Severe medical comorbidities precluding endoscopy and/or surgery 7) Pregnant or planning to become pregnant during period of study 8) Refusing or unable to provide written informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8558 |
| Other | METC Utrecht : METC 20-015 |
| CCMO | NL72398.041.19 |
| OMON | NL-OMON50168 |