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Trial Title:
Deeper Intubation Make Effects on Cervical Esophageal ESD
NCT ID:
NCT06420258
Condition:
Carcinoma in Situ of Cervical Part of Esophagus
Conditions: Official terms:
Carcinoma in Situ
Conditions: Keywords:
Deep tracheal intubation
Cervical esophageal cancer
ESD
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Masking description:
Each group allocation will be sealed in an opaque envelope with a code written on the
outside. These sealed envelopes will be handed over to the researchers. When a study
participant meets the inclusion and exclusion criteria upon entry into the study, they
will be assigned a number. Subsequently, the corresponding envelope with the assigned
number will be opened, and the intervention will be carried out according to the group
allocation specified in the envelope. The treatment plan for each research participant
will be determined by the generated random sequence.
Intervention:
Intervention type:
Procedure
Intervention name:
Deeper endotracheal intubation
Description:
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.
Arm group label:
Deeper endotracheal intubation
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Provintial Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Liang, MD
Phone:
+86 18120888996
Email:
fjsllw@163.com
Start date:
October 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Source:
Fujian Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06420258
