Non-intubated Versus Intubated Anesthesia in Thoracoscopic Esophagectomy for Esophageal Cancer

NCT07104838 | Not Yet Recruiting

• 1 other identifier: EC-TUBELESS-RCT-2025
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  From anesthesia induction to 30 days postoperatively

Study Arms (2)

Intubated

NO INTERVENTION

Non-intubated

EXPERIMENTAL

Procedure: Non-intubated spontaneous ventilation anesthesia

Interventions

Non-intubated spontaneous ventilation anesthesia PROCEDURE

Non-intubated spontaneous ventilation anesthesia

Non-intubated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Guangzhou Institude of respiratory health

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09