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Recruiting NCT06420258

Deeper Intubation Make Effects on Cervical Esophageal ESD

Phase IV Interventional Carcinoma in Situ of Cervical Part of Esophagus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deeper endotracheal intubation.
Who it may be relevant to
Registry conditions: Carcinoma in Situ of Cervical Part of Esophagus. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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.

Overview

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.

Interventions

  • Procedure Deeper endotracheal intubation
    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 outcome measures

  • the rate of complete resection and postoperative stricture [Time frame: Seven days and three months after ESD procedure]
Secondary outcome measures (1)
  • ESD procedural time and other procedure-related complications [Time frame: During procedures and just after ESD procedure.]

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian Provintial Hospital — Fuzhou

Publications

  • Xu Y, Wu Y, Deng W, Guo X, Gao P, Yang S, Chen Y, Zhou P, Liang W. More efficient endoscopic submucosal dissection with deep endotracheal intubation for superficial cervical esophageal carcinoma: a dual-center, prospective, randomized controlled study. Gastrointest Endosc. 2025 Mar;101(3):655-658. doi: 10.1016/j.gie.2024.09.018. Epub 2024 Sep 13. PMID 39278284

Identifiers

NCT: NCT06420258 · K2023-10-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗