Clinical trial NCT04206696: Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
Official title: Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Invasive Surgery
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 384
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy.

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.

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

Primary outcomes:
measure: bleeding volume
timeFrame: Between July 2010 and August 2016
measure: operation time
timeFrame: Between July 2010 and August 2016
measure: complications
timeFrame: Between July 2010 and August 2016
measure: mortality
timeFrame: Between July 2010 and August 2016
measure: lymphadenectomy
timeFrame: Between July 2010 and August 2016
Secondary outcomes:
measure: 2-year overall survival rate
timeFrame: Between August 2016 and August 2018
measure: 2-year disease-free survival
timeFrame: Between August 2016 and August 2018
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Shandong University
name: Xiaogang Zhao, Doctor
role: STUDY_DIRECTOR
References: