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

NCT ID: NCT07104838

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intubated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non-intubated

Group Type: EXPERIMENTAL

Non-intubated spontaneous ventilation anesthesia

Intervention Type: PROCEDURE

Non-intubated spontaneous ventilation anesthesia

Interventions

Non-intubated spontaneous ventilation anesthesia

Non-intubated spontaneous ventilation anesthesia

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

head of Guangzhou Institude of respiratory health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EC-TUBELESS-RCT-2025

Identifier Type: -

Identifier Source: org_study_id