NCT04652180Recruiting
Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Clinical Trial Of Safety Of Robot-assisted Thoracic Approach Verus Open Transthoracic Esophagectomy in Esophageal Cancer.
Source: ClinicalTrials.gov · Last updated 1 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer. If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 9 Nov 2020
- Start date
- 6 Nov 2020
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04652180
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 6 Nov 2020 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Stage IV or GEJ Siewert III esophageal cancer.
Other
- Contraindication of transthoracic esophagectomy in two fields.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.