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Completed

NCT Number: NCT04217239

A Comparison 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunpeng Zhao

Jinan, Shandong, 250033, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIE Ivor- Lewis

Procedure

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

MIE McKeown

Procedure

minimally invasive esophagectomy (MIE) with cervical anastomosis

Primary outcomes

  1. Overall postoperative complications

    Time frame: within one month

    Overall postoperative complication rates

Secondary outcomes

  1. Operating time

    Time frame: 1 day

    Operating time in minutes

  2. Lymph nodes harvested

    Time frame: 1 day

    Lymph nodes harvested in number

  3. Blood loss

    Time frame: 1 day

    Blood loss in milliliter

  4. Anastomotic leak

    Time frame: within one month

    Anastomotic leak in rate

  5. Pulmonary complication

    Time frame: 1 month

    Pulmonary complication in rate

  6. Anastomotic stenosis

    Time frame: within three months

    Anastomotic stenosis in rate

  7. recurrent laryngeal nerve injury

    Time frame: within three months

    recurrent laryngeal nerve injury in rate

  8. Chylothorax

    Time frame: within one month

    Chylothorax in rate

  9. Cardiac arrhythmia

    Time frame: within one month

    Cardiac arrhythmia in rate

  10. Laboratory findings

    Time frame: within 3 days

    Three-day postoperative laboratory findings including ALB, PA, Glob, etc.

  11. Hospital stay

    Time frame: within 60 days

    Hospital stay in days

  12. mortality

    Time frame: within 30 and 90 days

    mortality in rate

  13. progression-free survival

    Time frame: within 5 years

    progression-free survival in rate

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2020
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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