NCT07104838Not yet recruiting
Non-intubated Versus Intubated Anesthesia in Thoracoscopic Esophagectomy for Esophageal Cancer
Efficacy and Safety of Non-intubated Versus Intubated Anesthesia in Thoracoscopic Radical Esophagectomy for Esophageal Cancer: A Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- NCT number
- NCT07104838
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Oct 2025 to the primary completion date, 1 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of upper thoracic or intrathoracic surgery
- Known allergy or intolerance to anesthetic agents
Other
- Severe risk of aspiration due to reflux, gastric retention, or hiatal hernia
- Body mass index (BMI) ≥ 30 kg/m²
- Extensive pleural adhesions discovered preoperatively
- Pregnancy or lactation
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.