Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy .
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Esophagectomy
Procedure/SurgeryIn this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Robot-assisted thoracic approach in Ivor Lewis esophagectomyExperimental treatment 1 intervention
Group B: Open transthoracic approach in Ivor Lewis esophagectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Respiratory postoperative complications.
The primary outcome of this study is the percentage of respiratory complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC). by means of AME chest approach by robot and thoracotomy (classic surgery).
Time frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.Secondary outcomes
1
Postoperative complications.
Estimate the percentage of overall complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC) by means of Robot-assisted thoracic approach and thoracotomy (classic surgery).
Time frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.2
Individual components of the primary endpoint (major and minor complications).
Major complications (MCDC Grade 2-4): anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding), gastric tube necrosis (proven by gastroscopy), pulmonary embolus, pneumothorax, deep vein thrombosis, myocardial infarction, vocal cord palsy or paralysis. Minor complications (MCDC Grade 1): wound infections, pleural effusions, delayed gastric emptying. All these postoperative complications will be properly and separately recorded in the electronic collection database.
Time frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge3
Postoperative mortality (during hospital stay up to 84+/-3 days after discharge).
(In hospital) mortality and mortality within 14+/-2 days and 84+/-3 days after hospital discharge will be reported. The cause of death will be noted.
Time frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.4
Operation related events.
Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic approach, set up time will be recorded separately. Unexpected events and complications occuring during operation will be recorded (e.g. massive hemorrhage, perforation of other organs). Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has tp be explained (absolute numbers/percentage).
Time frame
Day of surgery, up to 24 hours after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari de Bellvitge
Lead sponsor
University of Barcelona
Collaborator
Source ClinicalTrials.gov