A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

NCT ID: NCT04217239

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ivor-Lewis group

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Group Type EXPERIMENTAL

MIE Ivor- Lewis

Intervention Type PROCEDURE

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

McKeown group

minimally invasive esophagectomy (MIE) with cervical anastomosis

Group Type ACTIVE_COMPARATOR

MIE McKeown

Intervention Type PROCEDURE

minimally invasive esophagectomy (MIE) with cervical anastomosis

Interventions

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MIE Ivor- Lewis

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Intervention Type PROCEDURE

MIE McKeown

minimally invasive esophagectomy (MIE) with cervical anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yunpeng Zhao

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yunpeng Zhao

Role: primary

+8618766188692

References

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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.

Reference Type DERIVED
PMID: 34758861 (View on PubMed)

Other Identifiers

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MIE ZYP2

Identifier Type: -

Identifier Source: org_study_id

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