A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
Overview
- Phase
- Not Applicable
- Intervention
- MIE Ivor- Lewis
- Conditions
- Esophageal Cancer
- Sponsor
- The Second Hospital of Shandong University
- Enrollment
- 272
- Locations
- 1
- Primary Endpoint
- Overall postoperative complications
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ivor-Lewis group
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
Intervention: MIE Ivor- Lewis
McKeown group
minimally invasive esophagectomy (MIE) with cervical anastomosis
Intervention: MIE McKeown
Outcomes
Primary Outcomes
Overall postoperative complications
Time Frame: within one month
Overall postoperative complication rates
Secondary Outcomes
- progression-free survival(within 5 years)
- Operating time(1 day)
- Lymph nodes harvested(1 day)
- Blood loss(1 day)
- Anastomotic leak(within one month)
- Pulmonary complication(1 month)
- Anastomotic stenosis(within three months)
- recurrent laryngeal nerve injury(within three months)
- Chylothorax(within one month)
- Cardiac arrhythmia(within one month)
- Laboratory findings(within 3 days)
- Hospital stay(within 60 days)
- mortality(within 30 and 90 days)