Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus minimally invasive esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT-2 trial).

Recruiting

Conditions: esophageal cancer
10017990
10017998

Registration Number: NL-OMON51500

Lead Sponsor: niversity Medical Center Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 109

Inclusion Criteria

- Histologically proven squamous cell carcinoma, adenocarcinoma or
undifferentiated carcinoma of the intrathoracic esophagus (including Siewert I
and II)
- Surgically resectable (T1-4a, N0-3, M0)
- Age >= 18 and <= 90 years
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent

Exclusion Criteria

- Carcinoma of the cervical esophagus
- Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the
tumor in the gastric cardia (Siewert type III)
- Prior thoracic surgery at the right hemithorax or thoracic trauma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our hypothesis is that RAMIE has superior lymph node dissection compared to<br /><br>MIE. Therefore, the primary outcome of this study is the number of dissected<br /><br>lymph nodes. The resected specimen will be marked by the surgical team for the<br /><br>position of lymph node dissection. Evaluation will be performed by an<br /><br>experienced pathologist using standard protocols. Stage grouping will take<br /><br>place according to the Union Internationale Contre le Cancer (UICC) protocol<br /><br>using the TNM-8 classification. The exact localization of the lymph nodes is an<br /><br>essential part of the pathologic examination.</p><br>

Secondary Outcome Measures