## Protocol Section
### Identification Module
**NCT ID:** NCT06420258

**Brief Title:** Deeper Intubation Make Effects on Cervical Esophageal ESD

**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.

#### Organization Study ID Info
**ID:** K2023-10-008
#### Organization
**Class:** OTHER
**Full Name:** Fujian Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fujian Provincial Hospital

#### Responsible Party

**Investigator Affiliation:** Fujian Provincial Hospital

**Investigator Full Name:** Wei Liang

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Carcinoma in Situ of Cervical Part of Esophagus

**Keywords:**

- Deep tracheal intubation

- Cervical esophageal cancer

- ESD

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Procedure: Deeper endotracheal intubation

**Label:** Deeper endotracheal intubation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Conventional endotracheal intubation

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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.

**Name:** Deeper endotracheal intubation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** the rate of complete resection and postoperative stricture

**Time Frame:** Seven days and three months after ESD procedure

#### Secondary Outcomes

**Measure:** ESD procedural time and other procedure-related complications

**Time Frame:** During procedures and just after ESD procedure.

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 454202013@qq.com

**Name:** Yanqin Xu, MD

**Phone:** +86 13599382136

**Role:** CONTACT

**Contact 2:**

**Email:** fjsllw@163.com

**Name:** Wei Liang, MD

**Phone:** +86 18120888996

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Email:** fjsllw@163.com

- **Name:** Wei Liang, MD

- **Phone:** +86 18120888996

- **Role:** CONTACT

**Country:** China

**Facility:** Fujian Provintial Hospital

**State:** Fujian

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Fujian Provintial Hospital

**Name:** Wei Liang, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5535

- Name: Carcinoma in Situ

- Relevance: HIGH

- As Found: Carcinoma in Situ

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002278

- Term: Carcinoma in Situ

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
