Comparing robot-assisted and open surgery for esophageal cancer
Clinical Trial Of Safety Of Robot-assisted Thoracic Approach Verus Open Transthoracic Esophagectomy in Esophageal Cancer.
This study is testing if robot-assisted surgery for esophageal cancer is as effective or better than traditional open surgery in helping patients recover and live well after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT04652180 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that aims to compare the effectiveness of a robot-assisted thoracic approach to the traditional open transthoracic esophagectomy for patients with resectable esophageal cancer. The study will evaluate postoperative complications, blood loss, hospital stay duration, and overall quality of life following surgery. By analyzing these factors, the trial seeks to determine if the robot-assisted method can provide similar or better oncologic outcomes while reducing complications compared to the standard open approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed resectable esophageal cancer.
Not a fit: Patients with advanced stage IV esophageal cancer or those with contraindications for transthoracic esophagectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer postoperative complications and improved recovery for patients undergoing surgery for esophageal cancer.
How similar studies have performed: Previous studies have shown promising results for minimally invasive techniques in esophageal surgery, suggesting potential benefits of robot-assisted approaches, although this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Histologically proven adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma or carcinoma of the gastro-esophageal junction (GEJ) Siewert I or II. * Surgical resectable (T1-4a, N0-3, M0). * Childbearing potential women (period between menarche and menopause), pregnancy negative test is mandatory. * Written informed consent. Exclusion Criteria: * Stage IV or GEJ Siewert III esophageal cancer. * Contraindication of transthoracic esophagectomy in two fields. * Pre- or concomitant cancer or conditions which interferes with the study (e.g. prior thoracic surgery or trauma. Rationale: these patients may undergo open resection).
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Natàlia Cornellà, Surgeon
- Email: nataliacornellagcirurgia@gmail.com
- Phone: +34645976556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.