A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Not Applicable

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Procedure: MIE Ivor- Lewis; Procedure: MIE McKeown

• Registration Number: NCT04217239
• Lead Sponsor: The Second Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16
• Primary Completion: 2023-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivor-Lewis group	MIE Ivor- Lewis	minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
McKeown group	MIE McKeown	minimally invasive esophagectomy (MIE) with cervical anastomosis

Primary Outcome Measures

Name	Time	Method
Anastomotic stenosis	within three months	Anastomotic stenosis in rate
Chylothorax	within one month	Chylothorax in rate
Blood loss	1 day	Blood loss in milliliter
Lymph nodes harvested	1 day	Lymph nodes harvested in number
Hospital stay	within 60 days	Hospital stay in days
Pulmonary complication	1 month	Pulmonary complication in rate
mortality	within 90 days	mortality in rate
Operating time	1 day	Operating time in minutes
Anastomotic leakage	within one month	Anastomotic leakage in rate
recurrent laryngeal nerve injury	within three months	recurrent laryngeal nerve injury in rate
Cardiac arrhythmia	within one month	Cardiac arrhythmia in rate

Secondary Outcome Measures

Name	Time	Method
progression-free survival	within 5 years	progression-free survival in rate
overall survival	within 5 years	overall survival in rate

Trial Locations

Locations (1)

Yunpeng Zhao; 🇨🇳 Jinan, Shandong, China