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


- candidate number22324
- NTR NumberNTR5245
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2015
- Secondary IDs2014_406 
- Public TitleSentinel node Navigation surgery in early esophageal Adenocarcinoma Patients: the SNAP study
- Scientific TitleSentinel node Navigation surgery in early esophageal Adenocarcinoma Patients: the SNAP study
- ACRONYMSNAP-study
- hypothesisWe hypothesize that SNNS might be of great value in early esophageal cancer, especially in the treatment of high-risk early EAC (T1b-tumors). A treatment algorithm consisting of endoscopic resection of the tumor, followed by SNNS and (adjusted) LN dissection may preclude patients with a tumor-negative sentinel node from esophagectomy and associated morbidity and mortality. Before applying this technique in this treatment algorithm however, SNNS needs to be validated in this specific patient group and the surgical team will have to be trained in performing the procedure.
- Healt Condition(s) or Problem(s) studiedEarly esophageal cancer
- Inclusion criteria- Early esophageal adenocarcinoma, staged as T1 (confined to the mucosa or submucosa)
- Clinical condition allowing esophagectomy
- Signed informed consent
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2015
- planned closingdate1-aug-2016
- Target number of participants5
- Interventionssentinel node procedure, followed by esophagectomy and gastric tube reconstruction
- Primary outcome- 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 outcome- Procedure time of sentinel node navigation surgery
- Number of tumor-positive lymph nodes, subdivided per lymph node station
- Adverse events
- Timepointsn/a
- Trial web sitenot available
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H. Künzli
- CONTACT for SCIENTIFIC QUERIES H. Künzli
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications-
- Brief summarySeveral studies already showed that SNNS is feasible in esophageal cancer and associated with high detection and accuracy rates (88-100% and 78-100%, respectively) and a high sensitivity (78-100%). Early esophageal cancer (T1-tumors) are associated with the best results, while patients with advanced carcinoma are being considered non-suitable candidates because of the destruction of lymph vessels by the tumor and neo-adjuvant therapy and the formation of fibrosis after chemoradiation therapy (10, 11, 12, 13, 14 and Takeuchi et al, abstract ISDE 2014). However, none of the available studies investigated the value of SNNS in patients who have undergone an endoscopic resection of an early EAC. Furthermore, studies using an endoscopic gamma probe and subsequently performing a minimally invasive esophagectomy, are scarce. We hypothesize that SNNS might be of great value in early esophageal cancer, especially in the treatment of high-risk early EAC (T1b-tumors). A treatment algorithm consisting of endoscopic resection of the tumor, followed by SNNS and (adjusted) LN dissection may preclude patients with a tumor-negative sentinel node from esophagectomy and associated morbidity and mortality. Before applying this technique in this treatment algorithm however, SNNS needs to be validated in this specific patient group and the surgical team will have to be trained in performing the procedure.
- Main changes (audit trail)
- RECORD9-jun-2015 - 18-aug-2015


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