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

Chinese Academy of Medical Sciences648 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

648

Conditions

Esophageal Carcinoma

Interventions

MIEPROCEDURE

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

OEPROCEDURE

Patients will be treated with traditional three incisions esophagectomy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (13)

Cancer Hospital of Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

RECRUITING

China-japan friendship hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The incidence of respiratory complications

Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.

Time frame: 1 months

Secondary Outcomes

Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer

To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups.

Time frame: 2 years

The incidence of postoperative complications except respiratory complications

Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification

Time frame: 1 months

lung function

lung function will be measured by VC,FVC,FEV1,DLCO

Time frame: before operation, 1, 3 months after surgery

Pain Scores after surgery

Pain Scores will be measured by Brief pain inventory(BPI)

Time frame: before operation, 1, 3 days and 1, 3, 6 months after surgery

Health-related quality of life scores（HRQoL）

HRQoL will be measured by EORTC QLO-C30, QLQ-OES18

Time frame: before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery

Central Contacts

Jie He, MD

CONTACT

mietrials@126.com;mjwtrials@126.com

Data from ClinicalTrials.gov

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