A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

February 3, 2026 updated by: The Second Hospital of Shandong University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033
        • Yunpeng Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivor-Lewis group
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
Procedure: MIE Ivor- Lewis
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
Active Comparator: McKeown group
minimally invasive esophagectomy (MIE) with cervical anastomosis
Procedure: MIE McKeown
minimally invasive esophagectomy (MIE) with cervical anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall postoperative complications
Time Frame: within one month
Overall postoperative complication rates
within one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: 1 day
Operating time in minutes
1 day
Blood loss
Time Frame: 1 day
Blood loss in milliliter
1 day
Lymph nodes harvested
Time Frame: 1 day
Lymph nodes harvested in number
1 day
Pulmonary complication
Time Frame: 1 month
Pulmonary complication in rate
1 month
Anastomotic stenosis
Time Frame: within three months
Anastomotic stenosis in rate
within three months
recurrent laryngeal nerve injury
Time Frame: within three months
recurrent laryngeal nerve injury in rate
within three months
Chylothorax
Time Frame: within one month
Chylothorax in rate
within one month
Cardiac arrhythmia
Time Frame: within one month
Cardiac arrhythmia in rate
within one month
Hospital stay
Time Frame: within 60 days
Hospital stay in days
within 60 days
progression-free survival
Time Frame: within 5 years
progression-free survival in rate
within 5 years
Anastomotic leak
Time Frame: within one month
Anastomotic leak in rate
within one month
Laboratory findings
Time Frame: within 3 days
Three-day postoperative laboratory findings including ALB, PA, Glob, etc.
within 3 days
mortality
Time Frame: within 30 and 90 days
mortality in rate
within 30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIE ZYP2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe