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

May 6, 2026 updated by: Qianwen Liu, Sun Yat-sen University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE)
Accept IVMTE surgery
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.
Placebo Comparator: minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the incidence of surgical complications
Time Frame: From date of surgery until the date of 30 days after surgery, assessed up to 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From date of surgery until the date of the pathological report completed, assessed up to 120 months
R0 resection rate
From date of surgery until the date of the pathological report completed, assessed up to 120 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extent and number of lymph node dissection
Time Frame: From date of surgery until the date of the pathological report completed, assessed up to 120 months
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
Time Frame: From date of surgery until the date of first documented progression, assessed up to 24 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
Time Frame: From date of surgery until the date of death from any cause, whichever came first, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

September 18, 2024

Study Completion (Actual)

September 18, 2024

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-5010-2019-03-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overall Survival

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe