A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

The Second Hospital of Shandong University

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Procedure: MIE McKeown; Procedure: MIE Ivor- Lewis

Study type: Interventional

Funder types: Other

Identifiers

NCT04217239

MIE ZYP2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Ivor-Lewis group

Experimental group

Description:

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Treatment:

Procedure: MIE Ivor- Lewis

McKeown group

Active Comparator group

Description:

minimally invasive esophagectomy (MIE) with cervical anastomosis

Treatment:

Procedure: MIE McKeown