Non-intubated Versus Intubated Anesthesia in Thoracoscopic Esophagectomy for Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-intubated spontaneous ventilation anesthesia.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer (EsC). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Non-intubated Versus Intubated Anesthesia in Thoracoscopic Radical Esophagectomy for Esophageal Cancer: A Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Non-intubated spontaneous ventilation anesthesia
Non-intubated spontaneous ventilation anesthesia
Primary outcome measures
- Incidence of intraoperative and postoperative complications [Time frame: From anesthesia induction to 30 days postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07104838 · EC-TUBELESS-RCT-2025