Robot-assisted IVOR-LEWIS Esophagectomy
Paraules clau
Resum
Descripció
This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.
Dates
Darrera verificació: | 06/30/2019 |
Primer enviat: | 05/01/2017 |
Inscripció estimada enviada: | 05/01/2017 |
Publicat per primera vegada: | 05/03/2017 |
Última actualització enviada: | 07/10/2019 |
Publicació de l'última actualització: | 07/11/2019 |
Data d'inici de l'estudi real: | 06/13/2017 |
Data estimada de finalització primària: | 07/09/2019 |
Data estimada de finalització de l’estudi: | 04/03/2024 |
Condició o malaltia
Fase
Criteris d'elegibilitat
Edats elegibles per estudiar | 18 Years Per a 18 Years |
Sexes elegibles per estudiar | All |
Mètode de mostreig | Probability Sample |
Accepta voluntaris saludables | Sí |
Criteris | Inclusion Criteria: 1. Patients with histologically proven esophageal malignancy 2. All patients were within the American Society of Anesthesiologists (ASA) class I to III 3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease Exclusion Criteria: Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax |
Resultat
Mesures de resultats primaris
1. short-term postoperative complications [30 days after surgery]
2. long-term overall survival [five years after surgery]
Mesures de resultats secundaris
1. perioperative outcomes except for postoperative complications [30 days after surgery]