CompletedNot Applicable

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

China35 participantsStarted 2021-01-27

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 unders…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the incidence of surgical complications

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

Trial details

NCT IDNCT07581236

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-18

View on ClinicalTrials.gov More Esophageal Squamous Cell Cancer (SCC) trials