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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Esophageal Carcinoma

Treatments: Procedure: MIE; Procedure: OE

Study type: Interventional

Funder types: Other

Identifiers

NCT02355249

201412

Details and patient eligibility

About

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.

Enrollment: 648 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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648 participants in 2 patient groups

A group (MIE)

Experimental group

Description:

Via minimally invasive thoracol-laparoscopic esophagectomy.

Treatment:

Procedure: MIE

B group (OE)

Active Comparator group

Description:

Via traditional three incisions esophagectomy.

Treatment:

Procedure: OE