A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

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: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: MIE Ivor- Lewis; Procedure: MIE McKeown

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • Recruiting
      • Yunpeng Zhao
      • Contact: Yunpeng Zhao; Phone Number: +8618766188692; Email: zyp_baggio@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	progression-free survival in rate	within 5 years
overall survival	overall survival in rate	within 5 years

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University

Publications and helpful links

General Publications

• Zhao Y, Shan L, Peng C, Cong B, Zhao X. Learning curve for minimally invasive oesophagectomy of oesophageal cancer and survival analysis. J Cardiothorac Surg. 2021 Nov 10;16(1):328. doi: 10.1186/s13019-021-01712-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2028

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): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Thoracoscopic; laparoscopic; esophagectomy
• 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