Comparing deep intubation and traditional intubation for esophageal cancer treatment
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.
This study is testing whether deep tracheal intubation is safer and more effective than traditional intubation for patients with early cervical esophageal cancer during a specific type of surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fujian Provincial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06420258 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of deep tracheal intubation compared to traditional intubation during endoscopic submucosal dissection for early cervical esophageal cancer. Forty patients diagnosed with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia will be randomly assigned to either the deep intubation group or the traditional intubation group. The study will assess various outcomes, including operation time, perioperative complications, and postoperative short-term complications, to determine the effectiveness of the deep intubation approach.
Who should consider this trial
Good fit: Ideal candidates are patients with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia in the cervical esophagus who have not undergone prior radiotherapy or chemotherapy.
Not a fit: Patients with severe comorbidities or those who have received prior treatment for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of endoscopic procedures for patients with early esophageal cancer.
How similar studies have performed: While there is limited data on deep intubation specifically for this condition, similar studies have shown promising results in improving outcomes for endoscopic procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The lesions mainly involve superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) in the cervical esophagus; 2. There is no evidence of regional lymph node or distant metastasis on endoscopic ultrasound (EUS) or CT/MRI imaging; 3. Participants have a thorough understanding of this study and voluntarily sign the informed consent form. Exclusion Criteria: * 1\. Patients who have received radiotherapy or chemotherapy before endoscopic submucosal dissection surgery; 2. Patients with severe comorbidities who are not suitable for endoscopic submucosal dissection surgery.
Where this trial is running
Fuzhou, Fujian
- Fujian Provintial Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yanqin Xu, MD
- Email: 454202013@qq.com
- Phone: +86 13599382136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.