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

NCT07581236 | Completed DMC

• 1 other identifier: SL-5010-2019-03-03
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Esophageal cancer; Inflatable video-assisted mediastinoscopic transhiatal esophagectomy; Overall complication rate; Disease-free survival; Overall survival

Outcome Measures

Primary Outcomes (1)

• 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

  From date of surgery until the date of 30 days after surgery, assessed up to 30 days

Secondary Outcomes (1)

• R0 resection rate

  From date of surgery until the date of the pathological report completed, assessed up to 120 months

Other Outcomes (3)

• The extent and number of lymph node dissection

  From date of surgery until the date of the pathological report completed, assessed up to 120 months

• 1-year and 2-year DFS

  From date of surgery until the date of first documented progression, assessed up to 24 months

• 1-year and 2-year OS

  From date of surgery until the date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (2)

Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE)

EXPERIMENTAL

Accept IVMTE surgery

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

minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach

PLACEBO COMPARATOR

Procedure: Minimally invasive McKeown esophagectomy (MIME)

Interventions

Minimally invasive McKeown esophagectomy (MIME) PROCEDURE

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.

minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach

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

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.

Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has not undergone any prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments;
• The patient has been histopathologically confirmed and diagnosed with esophageal squamous cell carcinoma, including obtaining pathological specimens through fiberoptic esophagoscopy biopsy, endoscopic mucosal dissection, endoscopic mucosal resection, and other methods, and confirmed by pathological examination as thoracic esophageal squamous cell carcinoma (including adequate diagnosis by immunohistochemical staining);
• The patient has undergone comprehensive preoperative evaluation (including plain and enhanced computed tomography (CT) scans of the neck, chest, and abdomen, plain and enhanced magnetic resonance imaging (MRI) scans of the chest, endoscopic ultrasonography, fiberoptic bronchoscopy, and neck ultrasound), and the clinical stage, according to the Tumor-node-metastasis Classification (TNM staging), is cT1b-3N0M0 or cTis-1aN0M0, and the patient is not suitable for endoscopic resection (TNM staging according to the American Joint Committee on Cancer 8th edition staging system);
• The patient is aged between 18 and 70 years;
• The patient's hematology (including routine blood cell count, routine liver and kidney function tests, blood lipids, blood glucose, electrolyte levels, tumor markers, etc.) and organ function (liver, kidney, heart, etc.) are normal;
• The patient can understand this study and has signed the informed consent form.
• The patient has good cardiopulmonary function (left ventricular ejection fraction between 50-80%; forced expiratory volume in one second (FEV1) \>80% of predicted value).

You may not qualify if:

• Patients with severe calcification of the aorta;
• Patients with severe spinal deformities;
• Female patients during pregnancy or lactation;
• Patients who have undergone subtotal gastrectomy or total gastrectomy and cannot use the stomach to replace the esophagus;
• Patients who have undergone anti-tumor treatment (including chemotherapy, radiotherapy, surgery);
• Patients who have existing or concurrent significant bleeding disorders;
• Other uncontrollable and inoperable conditions;
• Patients with cervical spondylosis;
• Patients who lack informed consent due to psychological, family, social, or other factors;
• Patients with two or more primary malignant tumors at the same time;
• Patients who, after thorough evaluation, have severe cardiac, pulmonary, hepatic, renal dysfunction, or other conditions that make surgery intolerable;
• Patients with a history of diabetes for more than 10 years and whose blood glucose levels are not satisfactorily controlled.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 12, 2026
• Study Start: January 27, 2021
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: May 12, 2026

Record last verified: 2024-09

Locations

CN (1)