Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

NCT ID: NCT04206696

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 384 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-01
• Study Completion Date: 2019-01-01

Brief Summary

Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.

Detailed Description

Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.

Conditions

Minimally Invasive Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery

Exclusion Criteria

poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaogang Zhao, Doctor

Role: STUDY_DIRECTOR

The Second Hospital of Shandong University

Other Identifiers

MIE ZYP1

Identifier Type: -

Identifier Source: org_study_id