A Single-center, Single-arm Clinical Study Evaluating the Short-term Efficacy of Inflatable Mediastinoscopic-assisted Transhiatal Laparoscopic Esophagectomy for the Radical Resection of Thoracic Esophageal Cancer

Summary

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).

Conditions

• Esophageal Squamous Cell Cancer (SCC)
• Overall Survival
• Disease Free Survival

Interventions

PROCEDURE

inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy

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.

PROCEDURE

Minimally invasive McKeown esophagectomy (MIME)

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.

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-27

Primary Completion

2024-09-18

Completion

2024-09-18

Countries

• China

Study Locations