Yunpeng Zhao
Jinan, Shandong, 250033, China
NCT Number: NCT04217239
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.
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Notify Me30 year–80 year
All sexes
Interventional
Not applicable
Jinan, Shandong, 250033, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
minimally invasive esophagectomy (MIE) with cervical anastomosis
Time frame: within one month
Overall postoperative complication rates
Time frame: 1 day
Operating time in minutes
Time frame: 1 day
Lymph nodes harvested in number
Time frame: 1 day
Blood loss in milliliter
Time frame: within one month
Anastomotic leak in rate
Time frame: 1 month
Pulmonary complication in rate
Time frame: within three months
Anastomotic stenosis in rate
Time frame: within three months
recurrent laryngeal nerve injury in rate
Time frame: within one month
Chylothorax in rate
Time frame: within one month
Cardiac arrhythmia in rate
Time frame: within 3 days
Three-day postoperative laboratory findings including ALB, PA, Glob, etc.
Time frame: within 60 days
Hospital stay in days
Time frame: within 30 and 90 days
mortality in rate
Time frame: within 5 years
progression-free survival in rate
The Second Hospital of Shandong University
Other
A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
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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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