Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-01-31

Brief Summary

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This study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer.

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Detailed Description

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Conditions

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Esophageal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A group (MIE)

Via minimally invasive thoracol-laparoscopic esophagectomy.

Group Type EXPERIMENTAL

MIE

Intervention Type PROCEDURE

Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.

B group (OE)

Via traditional three incisions esophagectomy.

Group Type ACTIVE_COMPARATOR

OE

Intervention Type PROCEDURE

Patients will be treated with traditional three incisions esophagectomy.

Interventions

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MIE

Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.

Intervention Type PROCEDURE

OE

Patients will be treated with traditional three incisions esophagectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
2. 18≤age≤75
3. cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks;
4. ECOG PS scores≤2
5. Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel
6. European Clinical Oncology Group (ECOG) performance status 0,1 or 2
7. More than 12 months of expected survival
8. Tolerance of tracheal intubation and general anesthesia
9. Written informed consent

Exclusion Criteria

1. Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ)
2. Prior thoracic surgery which may effect this study
3. Pregnant or breast feeding
4. Inability to tolerance of tracheal intubation and general anesthesia
5. PS \>2
6. unstable disease
7. Poor compliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jie He

M.D. & Ph.D. , President of CICAMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie He, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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