Esophageal CarcinomaNCT07182266
Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer
An observational study of Esophageal Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Perioperative and oncologic benefits of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) are unclear. This retrospective study aimed to compare the differences in perioperative outcomes and survival between IVMTE and video-assisted McKeown esophagectomy (VME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma
- Type of treatment
- Injection or infusion
- How many people
- 1,661 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 1 Sep 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2021 to December 2023, patients with esophageal cancer who received IVMTE or VME were identified from the prospectively maintained esophageal cancer database at Zhongshan Hospital, Fudan University
Who may be able to join
- primary esophageal cancer confirmed by endoscopic biopsy and (II) diagnosed resectable tumors based on positron emission tomography-computed tomography (PET-CT) according to the International Union Against Cancer Tumor, Node, Metastasis (TNM) Classification (8th edition)
Who cannot join
- presence of other advanced malignancies, (II) insufficient clinical data, or (III) postoperative follow-up of less than 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer: A Comparative Study With Propensity-Score Matching Analysis
Perioperative and oncologic benefits of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) are unclear. This retrospective study aimed to compare the differences in perioperative outcomes and survival between IVMTE and video-assisted McKeown esophagectomy (VME).
- Conditions
- Esophageal Carcinoma
- Keywords
- esophageal carcinoma, mediastinoscopic, McKeown
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVMTE | The patient was positioned supine. A 5-cm cervical incision was made along the anterior border of the left sternocleidomastoid muscle as the main surgical route. The skin and subcutaneous tissues were carefully incised in layers. The left recurrent laryngeal nerve (RLN) was identified and traced, followed by mobilization of the cervical esophagus. A lap protector was inserted into the left incision to create a closed cavity, and the mediastinum was insufflated with carbon dioxide at 8 mmHg. Three 5-mm trocars were used for the specialized retractor, LigaSure Maryland jaw sealer, and mediastinoscope. Then, the esophagus was dissected up to the level of the carina or the inferior pulmonary vein. During this process, mediastinal lymph nodes were also removed, including bilateral RLN, paraesophageal, tracheobronchial, and subcarinal nodes. If necessary, the incision was then extended to the right neck to facilitate the dissection of the right cervical lymph nodes. | |
| VME | traditional video-assisted McKeown esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Disease-Free Survival, Overall Survival
Measured: within 2 years after surgery
Complication
follow the guidelines of the Esophageal Complications Consensus Group (ECCG) recommendations and Clavien-Dindo classification
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start4 Jan 2021
- Primary completion29 Dec 2023
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182266
- Sponsor's protocol ID
- B2024-122R
- Other IDs
- 20ZR1411600, SHDC2020CR4039
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data sharing plan is under consideration but must first be reviewed and approved by our ethics committee to ensure full compliance with participant confidentiality agreements.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer: A Comparative Study With Propensity-Score Matching Analysis
- ClinicalTrials.gov ID
- NCT07182266
- Acronym / sponsor ID
- B2024-122R
- Conditions
- Esophageal Carcinoma
- Keywords
- esophageal carcinoma, mediastinoscopic, McKeown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,661 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 19 Sep 2025 (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.
Perioperative and oncologic benefits of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) are unclear. This retrospective study aimed to compare the differences in perioperative outcomes and survival between IVMTE and video-assisted McKeown esophagectomy (VME).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVMTE | – | –The patient was positioned supine. A 5-cm cervical incision was made along the anterior border of the left sternocleidomastoid muscle as the main surgical route. The skin and subcutaneous tissues were carefully incised in layers. The left recurrent laryngeal nerve (RLN) was identified and traced, followed by mobilization of the cervical esophagus. A lap protector was inserted into the left incision to create a closed cavity, and the mediastinum was insufflated with carbon dioxide at 8 mmHg. Three 5-mm trocars were used for the specialized retractor, LigaSure Maryland jaw sealer, and mediastinoscope. Then, the esophagus was dissected up to the level of the carina or the inferior pulmonary vein. During this process, mediastinal lymph nodes were also removed, including bilateral RLN, paraesophageal, tracheobronchial, and subcarinal nodes. If necessary, the incision was then extended to the right neck to facilitate the dissection of the right cervical lymph nodes. |
| VME | – | –traditional video-assisted McKeown esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2021 to December 2023, patients with esophageal cancer who received IVMTE or VME were identified from the prospectively maintained esophageal cancer database at Zhongshan Hospital, Fudan University
Key inclusion criteria (1 listed)
- primary esophageal cancer confirmed by endoscopic biopsy and (II) diagnosed resectable tumors based on positron emission tomography-computed tomography (PET-CT) according to the International Union Against Cancer Tumor, Node, Metastasis (TNM) Classification (8th edition)
Key exclusion criteria (1 listed)
- presence of other advanced malignancies, (II) insufficient clinical data, or (III) postoperative follow-up of less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: within 2 years after surgery
Disease-Free Survival, Overall Survival
Complication
Time frame: perioperative
follow the guidelines of the Esophageal Complications Consensus Group (ECCG) recommendations and Clavien-Dindo classification
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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided. A data sharing plan is under consideration but must first be reviewed and approved by our ethics committee to ensure full compliance with participant confidentiality agreements.
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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?
An observational study of Esophageal Carcinoma, run by Shanghai Zhongshan Hospital 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 1 inclusion and 1 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 19 Sep 2025. 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. 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?
Survival (time frame: within 2 years after surgery). The study lists 2 primary outcomes in all. 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 19 Sep 2025.