Esophageal Squamous Cell Cancer (SCC)NCT07581236
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
A study testing inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy and Minimally invasive McKeown esophagectomy (MIME) in people with Esophageal Squamous Cell Cancer (SCC) and Overall Survival, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer (SCC), Overall Survival, Disease Free Survival
- What is being tested?
- inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy and Minimally invasive McKeown esophagectomy (MIME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 18 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy, Minimally invasive McKeown esophagectomy (MIME)
- Keywords
- Esophageal cancer, Inflatable video-assisted mediastinoscopic transhiatal esophagectomy, Overall complication rate, Disease-free survival, Overall survival
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopyProcedure or surgery
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.
Minimally invasive McKeown esophagectomy (MIME)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) | Experimental | Accept IVMTE surgery Receives: Procedure: inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy |
| minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach | Placebo comparator | Not described Receives: Procedure: Minimally invasive McKeown esophagectomy (MIME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of surgery until the date of 30 days after surgery, assessed up to 30 days
Secondary outcomes (1)
R0 resection rate
R0 resection rate
Measured: From date of surgery until the date of the pathological report completed, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start27 Jan 2021
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Cancer (SCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianwen Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581236
- Sponsor's protocol ID
- SL-5010-2019-03-03
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581236
- Acronym / sponsor ID
- SL-5010-2019-03-03
- Keywords
- Esophageal cancer, Inflatable video-assisted mediastinoscopic transhiatal esophagectomy, Overall complication rate, Disease-free survival, Overall survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) | Experimental | Procedure: inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopyAccept IVMTE surgery |
| minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach | Placebo comparator | Procedure: Minimally invasive McKeown esophagectomy (MIME) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopyUnder 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 or surgery | Inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) |
| 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. | Procedure or surgery | minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach |
Primary outcome
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
1 secondary outcome
R0 resection rate
Time frame: From date of surgery until the date of the pathological report completed, assessed up to 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy and Minimally invasive McKeown esophagectomy (MIME) in people with Esophageal Squamous Cell Cancer (SCC) and Overall Survival, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.