ThORAcolaparoscopic disseCtion of Lymph nodes involved in the drainage of the Esophagus: the ORACLE study

Completed

• Conditions: early esophageal carcinoma; early esophageal neoplasm; 10017990

• Registration Number: NL-OMON40220
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Age >17 years
- Esophageal cancer (EAC or ESSC)
- Clinical condition allowing surgical thoracolaparoscopic lymph node dissection and subsequent esophagectomy
- Signed informed consent

Exclusion Criteria

- Neo-adjuvant (chemo)radiation therapy
- Comorbidity interfering with the procedures
- Unable to provide signed informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The number of lymph nodes dissected subdivided per lymph node station.<br /><br>- Number of tumor positive lymph nodes (lymph node station documented)<br /><br>- Number of remaining lymph nodes in esophagectomy specimen, subdivided per<br /><br>lymph node station</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Procedure time of the thoracolaparoscopic lymph node dissection<br /><br>- Adverse events</p><br>