NCT04652180 Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
| NCT ID | NCT04652180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari de Bellvitge |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2020-11-06 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2020-11-06 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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).
Contact & Investigator
Leandre Farran, PhD Surgeon
STUDY DIRECTOR
Frequently Asked Questions
Who can join the NCT04652180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04652180 currently recruiting?
Yes, NCT04652180 is actively recruiting participants. Contact the research team at nataliacornellagcirurgia@gmail.com for enrollment information.
Where is the NCT04652180 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT04652180 clinical trial?
NCT04652180 is sponsored by Hospital Universitari de Bellvitge. The principal investigator is Leandre Farran, PhD Surgeon. The trial plans to enroll 108 participants.
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