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OpenTrials
Completed

NCT Number: NCT04206696

Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. bleeding volume

    Time frame: Between July 2010 and August 2016

    bleeding volume in milliliter

  2. operation time

    Time frame: Between July 2010 and August 2016

    operation time in minutes

  3. complications

    Time frame: Between July 2010 and August 2016

    complications in percentage

  4. mortality

    Time frame: Between July 2010 and August 2016

    mortality in percentage

  5. lymphadenectomy

    Time frame: Between July 2010 and August 2016

    lymphadenectomy in number

Secondary outcomes

  1. 2-year overall survival rate

    Time frame: Between August 2016 and August 2018

    2-year overall survival in percentage

  2. 2-year disease-free survival

    Time frame: Between August 2016 and August 2018

    2-year disease-free survival in percentage

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2019
First posted
Dec 20, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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