A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217239
• Other study ID #: MIE ZYP2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2022
• Source: The Second Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Procedure:
• MIE Ivor- Lewis
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
• MIE McKeown
minimally invasive esophagectomy (MIE) with cervical anastomosis

Locations

Country	Name	City	State
China	Yunpeng Zhao	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating time	Operating time in minutes	1 day
Primary	Blood loss	Blood loss in milliliter	1 day
Primary	Lymph nodes harvested	Lymph nodes harvested in number	1 day
Primary	Pulmonary complication	Pulmonary complication in rate	1 month
Primary	Anastomotic leakage	Anastomotic leakage in rate	within one month
Primary	Anastomotic stenosis	Anastomotic stenosis in rate	within three months
Primary	recurrent laryngeal nerve injury	recurrent laryngeal nerve injury in rate	within three months
Primary	Chylothorax	Chylothorax in rate	within one month
Primary	Cardiac arrhythmia	Cardiac arrhythmia in rate	within one month
Primary	Hospital stay	Hospital stay in days	within 60 days
Primary	mortality	mortality in rate	within 90 days
Secondary	progression-free survival	progression-free survival in rate	within 5 years
Secondary	overall survival	overall survival in rate	within 5 years