Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Completed

• Conditions: Minimally Invasive Surgery

• Registration Number: NCT04206696
• Lead Sponsor: The Second Hospital of Shandong University

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.

Study Timeline

• Study Start: 2010-07-01
• Primary Completion: 2016-08-01
• Study Completion: 2019-01-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Study First Posted: 2019-12-20
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bleeding volume	Between July 2010 and August 2016	bleeding volume in milliliter
complications	Between July 2010 and August 2016	complications in percentage
mortality	Between July 2010 and August 2016	mortality in percentage
lymphadenectomy	Between July 2010 and August 2016	lymphadenectomy in number
operation time	Between July 2010 and August 2016	operation time in minutes

Secondary Outcome Measures

Name	Time	Method
2-year disease-free survival	Between August 2016 and August 2018	2-year disease-free survival in percentage
2-year overall survival rate	Between August 2016 and August 2018	2-year overall survival in percentage