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NCT Number: NCT06420258

Deeper Intubation Make Effects on Cervical Esophageal ESD

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Deeper endotracheal intubation

Procedure

After general anesthesia, endotracheal intubation was conducted using an ultrafine endoscope (GIF-XP260NS, Olympus Corp., Japan), which allows observation of the exact position and avoids blindness caused by laryngoscopy. To prevent balloon compression of the CE after inflating, the endotracheal intubation tube was inserted above the tracheal carina, roughly the upper thoracic esophagus.

Primary outcomes

  1. the rate of complete resection and postoperative stricture

    Time frame: Seven days and three months after ESD procedure

Secondary outcomes

  1. ESD procedural time and other procedure-related complications

    Time frame: During procedures and just after ESD procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Liang, MD

CONTACT

[email protected]

+86 18120888996

Yanqin Xu, MD

CONTACT

[email protected]

+86 13599382136

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.