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FEASIBILITY OF SENTINEL NODE DETECTION IN ESOPHAGEAL CANCER

FEASIBILITY OF SENTINEL NODE DETECTION IN ESOPHAGEAL CANCER - FEASIBILITY OF SN IN ESOPHAGEAL CANCER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30292
Enrollment
25
Registered
2007-07-16
Start date
2006-12-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

ESOPHAGEAL CANCER

Interventions

LYMPHOSCINTIGRAPHY Tracer injection The patient is seen in the Department of Gastoenterology on the afternoon before the day of the surgery, or in the morning of the day of surgery. Before surgery,

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * patient has to be fit to undergo SN biopsy/surgery;* before registration for this study, informed consent must be obtained ;* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.;* no metastatic disease;* no previous treatment of cancer

Exclusion criteria

Exclusion criteria: -metastatic disease -previous treatment of cancer

Design outcomes

Primary

MeasureTime frame
All resection specimens will be assessted by a senior pathologist. Specimen analysis will be performed in a standardized fashion with prospective documentation of all assessed parameters. Classification of the depth of tumor infiltration will be performed according to standard criteria into high-grade intraepithelial neoplasia, carcinoma limited to the mucosa (pT1a category), and carcinoma invading the submucosal layer but not beyond (pT1b category). The tumor with the deepest depth of infiltration or largest diameter will be chosen as the main tumor. All removed lymph nodes will be identified according to their location (celiac axis, left gastric artery, lesser gastric curvature, left and right paracardial, paraesophageal distal in the posterior lower mediastinum, bifurcation, and upper mediastinum), counted, and assessed separately. Standard histopathologic analysis of lymph nodes will be performed by serial sections of 5-µm thickness and staining with hematoxylin-eosin and van Gieson. Immunohistochemistry will be performed to search for lymph node micrometastases in all patients staged as pN0 on standard histology as described previously. Lymphatic vessel invasion (also termed lymphangiosis) is defined as tumor cell spread through the lymphatic vessels (ie, carcinoma cells floating within the endothelial-lined space). Routine follow up will be performed by the oncologic outpatient clinic or the patient's general practitioner. The follow up of these patients will be 24 months. All evaluated parameters will be prospectively documented throughout the study period in a dedicated database. Tested variables included *histologic tumor type* (adenocarcinoma vs squamous cell carcinoma), *depth of tumor infiltration* (HGIEN/pT1a vs pT1b), *number of removed nodes,* *presence of lymph node metastases* (pN0 vs pN+), *surgical approach* (abdominothoracic vs radical transhiatal), and *tumor location* (above/at vs below the level of the tracheal bif

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)