NCT04217239

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

January 1, 2020

Last Update Submit

February 3, 2026

Conditions

Esophageal Cancer

Keywords

Thoracoscopiclaparoscopicesophagectomy

Outcome Measures

Primary Outcomes (1)

  • Overall postoperative complications

    Overall postoperative complication rates

    within one month

Secondary Outcomes (13)

  • Operating time

    1 day

  • Lymph nodes harvested

    1 day

  • Blood loss

    1 day

  • Anastomotic leak

    within one month

  • Pulmonary complication

    1 month

  • +8 more secondary outcomes

Study Arms (2)

Ivor-Lewis group

EXPERIMENTAL

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Procedure: MIE Ivor- Lewis

McKeown group

ACTIVE COMPARATOR

minimally invasive esophagectomy (MIE) with cervical anastomosis

Procedure: MIE McKeown

Interventions

MIE Ivor- LewisPROCEDURE

minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Ivor-Lewis group
MIE McKeownPROCEDURE

minimally invasive esophagectomy (MIE) with cervical anastomosis

McKeown group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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;

You may not qualify if:

  • (I) cardiopulmonary function not good enough for surgery;
  • (II) Patients with hybrid MIE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunpeng Zhao

Jinan, Shandong, 250033, China

Location

Related Publications (1)

  • 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.

    PMID: 34758861DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2020

First Posted

January 3, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

CN(1)