Deeper Intubation Make Effects on Cervical Esophageal ESD

ConditionCarcinoma in Situ of Cervical Part of Esophagus

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorFujian Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Deeper endotracheal intubation
Procedure/Surgery
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Deeper endotracheal intubationExperimental treatment 1 intervention

Group B: Conventional endotracheal intubationNo intervention 0 interventions

Trial 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

Time frame

During procedures and just after ESD procedure.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

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