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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40220

Enrollment

Registered

2013-12-20

Start date

2014-01-28

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

early esophageal carcinoma early esophageal neoplasm

Interventions

scopic lymph node dissection of lymph nodes involved in the drainage of the esophagus, directly followed by esophageal-cardia resection with formation of a gastric or colonic conduit.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- The number of lymph nodes dissected subdivided per lymph node station. - Number of tumor positive lymph nodes (lymph node station documented) - Number of remaining lymph nodes in esophagectomy specimen, subdivided per lymph node station	—

Secondary

Measure	Time frame
- Procedure time of the thoracolaparoscopic lymph node dissection - Adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)