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A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217239
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Shandong University

Brief Summary:

Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:

MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: MIE Ivor- Lewis Procedure: MIE McKeown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ivor-Lewis group
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
Procedure: MIE Ivor- Lewis
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis

Active Comparator: McKeown group
minimally invasive esophagectomy (MIE) with cervical anastomosis
Procedure: MIE McKeown
minimally invasive esophagectomy (MIE) with cervical anastomosis




Primary Outcome Measures :
  1. Operating time [ Time Frame: 1 day ]
    Operating time in minutes

  2. Blood loss [ Time Frame: 1 day ]
    Blood loss in milliliter

  3. Lymph nodes harvested [ Time Frame: 1 day ]
    Lymph nodes harvested in number

  4. Pulmonary complication [ Time Frame: 1 month ]
    Pulmonary complication in rate

  5. Anastomotic leakage [ Time Frame: within one month ]
    Anastomotic leakage in rate

  6. Anastomotic stenosis [ Time Frame: within three months ]
    Anastomotic stenosis in rate

  7. recurrent laryngeal nerve injury [ Time Frame: within three months ]
    recurrent laryngeal nerve injury in rate

  8. Chylothorax [ Time Frame: within one month ]
    Chylothorax in rate

  9. Cardiac arrhythmia [ Time Frame: within one month ]
    Cardiac arrhythmia in rate

  10. Hospital stay [ Time Frame: within 60 days ]
    Hospital stay in days

  11. mortality [ Time Frame: within 90 days ]
    mortality in rate


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: within 5 years ]
    progression-free survival in rate

  2. overall survival [ Time Frame: within 5 years ]
    overall survival in rate



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;

(II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;

(III) Patients without a previous history of cancer;

(IV) Patients without a previous history of neck or chest surgery;

Exclusion Criteria:

(I) cardiopulmonary function not good enough for surgery;

(II) Patients with hybrid MIE


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217239


Locations
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China, Shandong
Yunpeng Zhao Recruiting
Jinan, Shandong, China, 250033
Contact: Yunpeng Zhao    +8618766188692    zyp_baggio@163.com   
Sponsors and Collaborators
The Second Hospital of Shandong University
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Responsible Party: The Second Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04217239    
Other Study ID Numbers: MIE ZYP2
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Shandong University:
Thoracoscopic
laparoscopic
esophagectomy