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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deeper endotracheal intubation | Experimental | 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 |
|
| Conventional endotracheal intubation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of complete resection and postoperative stricture | Seven days and three months after ESD procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ESD procedural time and other procedure-related complications | During procedures and just after ESD procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqin Xu, MD | Contact | +86 13599382136 | 454202013@qq.com | |
| Wei Liang, MD | Contact | +86 18120888996 | fjsllw@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Liang, MD | Fujian Provintial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provintial Hospital | Recruiting | Fuzhou | Fujian | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39278284 | Derived | 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. |
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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.
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