Esophageal Cancer
Conditions
Keywords
Thoracoscopic, laparoscopic, esophagectomy
Brief summary
Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches: MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.
Interventions
PROCEDUREMIE Ivor- Lewis
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
PROCEDUREMIE McKeown
minimally invasive esophagectomy (MIE) with cervical anastomosis
Sponsors
The Second Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function; (II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor; (III) Patients without a previous history of cancer; (IV) Patients without a previous history of neck or chest surgery;
Exclusion criteria
(I) cardiopulmonary function not good enough for surgery; (II) Patients with hybrid MIE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall postoperative complications | within one month | Overall postoperative complication rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | 1 day | Operating time in minutes |
| Lymph nodes harvested | 1 day | Lymph nodes harvested in number |
| Blood loss | 1 day | Blood loss in milliliter |
| Anastomotic leak | within one month | Anastomotic leak in rate |
| Pulmonary complication | 1 month | Pulmonary complication in rate |
| Anastomotic stenosis | within three months | Anastomotic stenosis in rate |
| recurrent laryngeal nerve injury | within three months | recurrent laryngeal nerve injury in rate |
| Chylothorax | within one month | Chylothorax in rate |
| Cardiac arrhythmia | within one month | Cardiac arrhythmia in rate |
| Laboratory findings | within 3 days | Three-day postoperative laboratory findings including ALB, PA, Glob, etc. |
| Hospital stay | within 60 days | Hospital stay in days |
| mortality | within 30 and 90 days | mortality in rate |
| progression-free survival | within 5 years | progression-free survival in rate |
Countries
China
Outcome results
None listed