Esophageal Cancer (EsC)NCT07104838
Non-intubated Versus Intubated Anesthesia in Thoracoscopic Esophagectomy for Esophageal Cancer
A study testing Non-intubated spontaneous ventilation anesthesia in people with Esophageal Cancer (EsC), run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
This is a prospective, single-center, non-inferiority randomized controlled trial designed to evaluate the perioperative safety and feasibility of non-intubated spontaneous ventilation anesthesia (NIV) compared to conventional intubated mechanical ventilation anesthesia (IMV) in patients undergoing thoracoscopic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer (EsC)
- What is being tested?
- Non-intubated spontaneous ventilation anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Diagnosed with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (clinical stage I-III)
- Scheduled to undergo thoracoscopic esophagectomy
- American Society of Anesthesiologists (ASA) score ≤ III
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Preoperative pulmonary function test with FEV₁ ≥ 50% predicted
- Written informed consent obtained
Who cannot join
- Severe risk of aspiration due to reflux, gastric retention, or hiatal hernia
- Body mass index (BMI) ≥ 30 kg/m²
- Extensive pleural adhesions discovered preoperatively
- History of upper thoracic or intrathoracic surgery
- Pregnancy or lactation
- Known allergy or intolerance to anesthetic agents
About this study
Official title: Efficacy and Safety of Non-intubated Versus Intubated Anesthesia in Thoracoscopic Radical Esophagectomy for Esophageal Cancer: A Prospective Randomized Controlled Trial
This is a prospective, single-center, non-inferiority randomized controlled trial designed to evaluate the perioperative safety and feasibility of non-intubated spontaneous ventilation anesthesia (NIV) compared to conventional intubated mechanical ventilation anesthesia (IMV) in patients undergoing thoracoscopic esophagectomy for esophageal cancer. The study will be conducted at the First Affiliated Hospital of Guangzhou Medical University and aims to assess whether the non-intubated approach can offer comparable or better outcomes in terms of intraoperative and postoperative complications, anesthetic drug consumption, recovery parameters, and overall postoperative rehabilitation.
Eligible patients aged 18 to 75 years with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (stage I-III) will be randomly assigned (1:1) to receive either NIV using a laryngeal mask airway or IMV with a double-lumen endotracheal tube. Both groups will undergo the same thoracoscopic and laparoscopic surgical procedures, and anesthesia will be managed with standardized protocols. The primary outcome is the incidence of intraoperative and postoperative complications, including hypoxemia, hypercapnia, respiratory failure, and the need for conversion to intubation. Secondary outcomes include anesthetic drug dosage, intraoperative hemodynamic stability, postoperative pain scores, time to ambulation, length of hospital stay, and 30-day readmission rate.
This trial complies with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
- Conditions
- Esophageal Cancer (EsC)
- Being tested
- Non-intubated spontaneous ventilation anesthesia
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intubated spontaneous ventilation anesthesiaProcedure or surgery
Non-intubated spontaneous ventilation anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intubated | No intervention | Not described |
| Non-intubated | Experimental | Not described Receives: Procedure: Non-intubated spontaneous ventilation anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative and postoperative complications
Composite incidence of complications occurring intraoperatively or within 30 days after surgery, including hypoxemia (SpO₂ < 90% for >1 minute), hypercapnia (PaCO₂ ≥ 65 mmHg), conversion to intubation (in the non-intubated group), severe arrhythmia, hemodynamic instability, postoperative pulmonary infection, anastomotic leakage, bleeding, pneumothorax, respiratory failure, and reintubation.
Measured: From anesthesia induction to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer (EsC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104838
- Sponsor's protocol ID
- EC-TUBELESS-RCT-2025
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non-intubated Versus Intubated Anesthesia in Thoracoscopic Radical Esophagectomy for Esophageal Cancer: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07104838
- Acronym / sponsor ID
- EC-TUBELESS-RCT-2025
- Conditions
- Esophageal Cancer (EsC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Aug 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.
This is a prospective, single-center, non-inferiority randomized controlled trial designed to evaluate the perioperative safety and feasibility of non-intubated spontaneous ventilation anesthesia (NIV) compared to conventional intubated mechanical ventilation anesthesia (IMV) in patients undergoing thoracoscopic esophagectomy for esophageal cancer. The study will be conducted at the First Affiliated Hospital of Guangzhou Medical University and aims to assess whether the non-intubated approach can offer comparable or better outcomes in terms of intraoperative and postoperative complications, anesthetic drug consumption, recovery parameters, and overall postoperative rehabilitation.
Eligible patients aged 18 to 75 years with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (stage I-III) will be randomly assigned (1:1) to receive either NIV using a laryngeal mask airway or IMV with a double-lumen endotracheal tube. Both groups will undergo the same thoracoscopic and laparoscopic surgical procedures, and anesthesia will be managed with standardized protocols. The primary outcome is the incidence of intraoperative and postoperative complications, including hypoxemia, hypercapnia, respiratory failure, and the need for conversion to intubation. Secondary outcomes include anesthetic drug dosage, intraoperative hemodynamic stability, postoperative pain scores, time to ambulation, length of hospital stay, and 30-day readmission rate.
This trial complies with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubated | No intervention | – |
| Non-intubated | Experimental | Procedure: Non-intubated spontaneous ventilation anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- Diagnosed with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (clinical stage I-III)
- Scheduled to undergo thoracoscopic esophagectomy
- American Society of Anesthesiologists (ASA) score ≤ III
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Key exclusion criteria (6 listed)
- Severe risk of aspiration due to reflux, gastric retention, or hiatal hernia
- Body mass index (BMI) ≥ 30 kg/m²
- Extensive pleural adhesions discovered preoperatively
- History of upper thoracic or intrathoracic surgery
- Pregnancy or lactation
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 |
|---|---|---|
| Non-intubated spontaneous ventilation anesthesiaNon-intubated spontaneous ventilation anesthesia | Procedure or surgery | Non-intubated |
Primary outcome
Incidence of intraoperative and postoperative complications
Time frame: From anesthesia induction to 30 days postoperatively
Composite incidence of complications occurring intraoperatively or within 30 days after surgery, including hypoxemia (SpO₂ < 90% for >1 minute), hypercapnia (PaCO₂ ≥ 65 mmHg), conversion to intubation (in the non-intubated group), severe arrhythmia, hemodynamic instability, postoperative pulmonary infection, anastomotic leakage, bleeding, pneumothorax, respiratory failure, and reintubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
Related trials for Esophageal Cancer (EsC)
Not yet recruitingObservational study
Effect of VExUS Score on Postoperative Pulmonary Complications in Elderly Patients
Esophageal Cancer (EsC), Postoperative Pulmonary Complications (PPCs)
Not yet recruitingObservational study
AI-Based Risk Prediction Model for Upper Digestive Tract Cancer
Gastric Cancer (GC), Premalignant Lesion
RecruitingObservational study
Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer
Esophageal Cancer (EsC)
Active, not recruitingObservational study
A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients
Esophageal Cancer (EsC)
Not yet recruitingPhase 3
Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial
Esophageal Cancer (EsC)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intubated spontaneous ventilation anesthesia in people with Esophageal Cancer (EsC), run by The First Affiliated Hospital of Guangzhou Medical University.
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 6 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: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of intraoperative and postoperative complications (time frame: From anesthesia induction to 30 days postoperatively). 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 25 Sep 2025.