Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Minimally Invasive Surgery Clinical Trial

Official title:

Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206696
• Other study ID #: MIE ZYP1
• Status: Completed
• Start date: July 1, 2010
• Est. completion date: January 1, 2019

Study information

• Verified date: December 2019
• Source: The Second Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: January 1, 2019
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Minimally Invasive Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding volume	bleeding volume in milliliter	Between July 2010 and August 2016
Primary	operation time	operation time in minutes	Between July 2010 and August 2016
Primary	complications	complications in percentage	Between July 2010 and August 2016
Primary	mortality	mortality in percentage	Between July 2010 and August 2016
Primary	lymphadenectomy	lymphadenectomy in number	Between July 2010 and August 2016
Secondary	2-year overall survival rate	2-year overall survival in percentage	Between August 2016 and August 2018
Secondary	2-year disease-free survival	2-year disease-free survival in percentage	Between August 2016 and August 2018