Sentinel node procedure in early esophageal carcinoma patients with suspicion of lymph node metastases

Sentinel node Navigation surgery in early esophageal Adenocarcinoma Patients with lymph node involvement: SNAP-IV study - SNAP-IV study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000878-15-NL

Enrollment

Registered

2020-03-24

Start date

2020-04-15

Completion date

Unknown

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal adenocarcinoma

Interventions

Trade Name: Nanocoll Product Name: 99m-Technetium-nanocolloid Product Code: V09DB01 Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Esophageal adenocarcinoma, clinically staged as T1N1M0 with an indication for esophagectomy 2) Fit for endoscopy and surgery per institution’s standards 3) Older than 18 years of age at time of informed consent 4) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Esophageal squamous cell carcinoma 2) Clinically staged as T>1, N>1 and/or M1 3) Neoadjuvant (chemo)radiation therapy 4) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green) 5) Severe medical comorbidities precluding endoscopy and/or surgery 6) Refusing or unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Validation of the accuracy of sentinel node navigation surgery (SNNS) for the detection of tumor-positive lymph nodes in patients with T1 esophageal adenocarcinoma and lymph node metastases. ;Secondary Objective: To introduce an esophageal preserving treatment regimen for high-risk T1b esophageal adenocarcinoma patients. ;Primary end point(s): Percentage of patients in whom tumor-positive LN(s) are detected as SN(s); defined as the number of patients with 1 or more tumor-positive LNs detected as SNs, reported separately per type of detection (SPECT/CT, probe-based or NIR camera).;Timepoint(s) of evaluation of this end point: After histopathological assessment of surgical resection specimens (lymph nodes and esophagus).	—

Measure

Time frame

Main Objective: Validation of the accuracy of sentinel node navigation surgery (SNNS) for the detection of tumor-positive lymph nodes in patients with T1 esophageal adenocarcinoma and lymph node metastases. ;Secondary Objective: To introduce an esophageal preserving treatment regimen for high-risk T1b esophageal adenocarcinoma patients. ;Primary end point(s): Percentage of patients in whom tumor-positive LN(s) are detected as SN(s); defined as the number of patients with 1 or more tumor-positive LNs detected as SNs, reported separately per type of detection (SPECT/CT, probe-based or NIR camera).;Timepoint(s) of evaluation of this end point: After histopathological assessment of surgical resection specimens (lymph nodes and esophagus).

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Secondary

Measure	Time frame
Secondary end point(s): 1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based or with a NIR camera. 2) Number of resected SN, location documented. 3) Ratio of number of dissected SNs and number of detected SNs on imaging. 4) Number of tumor-positive dissected SNs, subdivided per LN station. 5) Ratio of number of tumor-positive dissected SNs and number of detected SNs on imaging. 6) Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of SNs. 7) Additional yield of ICG-based SN detection over technetium SN detection. 8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR camera, which could not be dissected during surgery, location and reason documented. 9) Procedure time of SNNS. 10) Incidence and severity of all adverse events.;Timepoint(s) of evaluation of this end point: After surgical procedure and histopathological assessment of surgical resection specimens (lymph nodes and esophagus).	—

Measure

Time frame

Secondary end point(s): 1) Percentage of patients with a detectable SN, either on SPECT/CT, probe-based or with a NIR camera. 2) Number of resected SN, location documented. 3) Ratio of number of dissected SNs and number of detected SNs on imaging. 4) Number of tumor-positive dissected SNs, subdivided per LN station. 5) Ratio of number of tumor-positive dissected SNs and number of detected SNs on imaging. 6) Concordance of pre-operative SPECT/CT and perioperative probe-based and ICG-based detection of SNs. 7) Additional yield of ICG-based SN detection over technetium SN detection. 8) Number of detectable SNs, either on SPECT/CT, probe-based or with a NIR camera, which could not be dissected during surgery, location and reason documented. 9) Procedure time of SNNS. 10) Incidence and severity of all adverse events.;Timepoint(s) of evaluation of this end point: After surgical procedure and histopathological assessment of surgical resection specimens (lymph nodes and esophagus).

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Countries

Netherlands

Contacts

Public ContactDepartment of Gastroenterology

University Medical Center Utrecht

0031887556276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026