Completed

Comparison of Short-term and Long-term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy in Lower Thoracic Esophageal Cancer Treatment

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Study Aim

This study compares the short-term and long-term outcomes of Ivor-Lewis and McKeown minimally invasive esophagectomy in the treatment of lower thoracic esophageal cancer, focusing on overall postoperative complication rates.

What is being tested

MIE Ivor- Lewis

+ MIE McKeown

Procedure
Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

From 30 to 80 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorThe Second Hospital of Shandong University
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2020

Actual date on which the first participant was enrolled.

This study focuses on treating lower thoracic esophageal cancer and esophageal-gastric junction cancer. Traditional open surgery for these conditions often comes with high complication and mortality rates. To address this, a minimally invasive esophagectomy (MIE) was developed, which includes two main surgical approaches: MIE McKeown and MIE Ivor-Lewis. The goal of this study is to compare the safety and effectiveness of these two MIE approaches in the long and short term. This research is important as it aims to improve surgical outcomes and reduce complications for patients with these specific types of cancer. During the study, participants undergo either the MIE McKeown or MIE Ivor-Lewis procedure. The study then measures and compares the overall postoperative complication rates between the two groups. This helps determine which approach results in fewer complications and better patient outcomes. The potential benefits of participating include receiving a potentially safer and more effective surgical treatment for the specific type of cancer.

Official TitleA Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
NCT04217239
Principal SponsorThe Second Hospital of Shandong University
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

272 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

3 inclusion criteria required to participate
Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;

Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;

Patients without a previous history of cancer;

1 exclusion criteria prevent from participating
Patients with hybrid MIE

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Group II

Active Comparator
minimally invasive esophagectomy (MIE) with cervical anastomosis

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yunpeng Zhao

Jinan, ChinaOpen Yunpeng Zhao in Google Maps
CompletedOne Study Center