A Study on the Effectiveness and Safety of Intratracheal Deep Intubation Compared to Traditional Tracheal Intubation in Endoscopic Submucosal Dissection for Early Esophageal Cancer in the Cervical Esophagus: A Randomized Controlled Trial.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Carcinoma in Situ of Cervical Part of Esophagus
- Sponsor
- Fujian Provincial Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- the rate of complete resection and postoperative stricture
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
To compare the efficacy and safety of intratracheal deep intubation with traditional intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus, and to follow up and assess their short-term clinical outcomes.
Detailed Description
Forty patients with early esophageal cancer in the cervical esophagus scheduled for endoscopic submucosal dissection will be included. They will be randomly divided into two groups using sealed envelopes: approximately 20 patients in the intratracheal deep intubation group and 20 patients in the traditional intubation group. By comparing the operation time, perioperative complications, postoperative short-term complications, and other outcomes, we aim to elucidate the effectiveness and safety of deep intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus.
Investigators
Wei Liang
Doctor
Fujian Provincial Hospital
Eligibility Criteria
Inclusion Criteria
- •The lesions mainly involve superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) in the cervical esophagus;
- •There is no evidence of regional lymph node or distant metastasis on endoscopic ultrasound (EUS) or CT/MRI imaging;
- •Participants have a thorough understanding of this study and voluntarily sign the informed consent form.
Exclusion Criteria
- •Patients who have received radiotherapy or chemotherapy before endoscopic submucosal dissection surgery;
- •Patients with severe comorbidities who are not suitable for endoscopic submucosal dissection surgery.
Outcomes
Primary Outcomes
the rate of complete resection and postoperative stricture
Time Frame: Seven days and three months after ESD procedure
Secondary Outcomes
- ESD procedural time and other procedure-related complications(During procedures and just after ESD procedure.)