Abstract Background China has a high incidence of esophageal cancer, with surgery being the primary treatment modality. While the right thoracic approach for radical esophagectomy remains the standard surgical method, it is associated with a significant rate of postoperative complications. Given that the esophagus is a posterior mediastinal organ, a mediastinal approach for radical esophagectomy without thoracotomy could potentially reduce postoperative complications. However, this hypothesis has yet to be validated by prospective clinical studies. To explore this further, we conducted a single-center, single-arm clinical study to assess the short-term efficacy of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy for the treatment of thoracic esophageal cancer. Methods In this prospective, single-arm phase II clinical trial, 35 patients with cTis-3N0M0 thoracic esophageal squamous cell carcinoma (ESCC) were enrolled between March 2021 and September 2023. All patients underwent radical esophagectomy using IVMTE. The primary endpoint of the study was the overall surgical complication rate, while secondary endpoints included the R0 resection rate, the extent and number of lymph nodes dissected, the 1-year disease-free survival (DFS) rate, and the 1-year overall survival (OS) rate. To evaluate the outcomes, propensity score matching (PSM) analysis was performed, comparing the results with 70 cTis-3N0M0 ESCC patients who underwent minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach during the same period (March 2021 to September 2023).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Under general anesthesia, a left neck incision exposes the left recurrent laryngeal nerve. Left level VI nodes are cleared, left inferior thyroid vein ligated. A single-port mediastinoscopy with CO2 is performed: the esophagus is mobilized to the inferior pulmonary vein while protecting the trachea, left main bronchus and thoracic duct; a marker gauze is placed. Right recurrent laryngeal nerve nodes are cleared. Five abdominal ports enable gastric mobilization with division of short gastric and left gastric vessels, preserving the right gastroepiploic vessels, and lymphadenectomy at splenic artery, both crura and cardia. The hiatus is opened and lower esophagus dissected to join the neck, then the cardia is transected. The specimen is pulled out cervically, a mediastinal drain left. Via a small upper midline laparotomy, a gastric tube is formed, pulled retrosternally, and anastomosed to the cervical esophagus. Jejunostomy and closure complete the operation.
After positioning, right thoracoscopy: 4 ports; mobilize thoracic esophagus from inlet to hiatus, clearing mediastinal nodes including subcarinal and left RLN; transect at inlet. Then supine for laparoscopy: 5 ports; divide omentum, cut short gastric and left gastric vessels; open hiatus, pull specimen. Mini-laparotomy forms gastric tube. Left neck incision; protect left RLN; retrosternal pull-up of gastric tube; circular stapled anastomosis. Jejunostomy completes procedure.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Evaluate the incidence of surgical complications
All surgical complications should be monitored according to the recommendations of the ECCG, and the same patient may have multiple postoperative complications
Time frame: From date of surgery until the date of 30 days after surgery, assessed up to 30 days
R0 resection rate
R0 resection rate
Time frame: From date of surgery until the date of the pathological report completed, assessed up to 120 months
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