## Protocol Section
### Identification Module
**NCT ID:** NCT04222179

**Brief Title:** One Brand-new Maneuver to Place Nasoenteric Tube

**Official Title:** Tzu-chi General Hospital,Hualien County,Taiwan,ROC

#### Organization Study ID Info
**ID:** IRB106-10-A
#### Organization
**Class:** OTHER
**Full Name:** Buddhist Tzu Chi General Hospital
### Status Module
#### Completion Date
**Date:** 2020-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-07-10

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-08

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2020-07

#### Study First Post Date
**Date:** 2020-01-09
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-02
**Study First Submit QC Date:** 2020-01-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Buddhist Tzu Chi General Hospital

#### Responsible Party

**Investigator Affiliation:** Buddhist Tzu Chi General Hospital

**Investigator Full Name:** Jen-Shung Lin

**Investigator Title:** Prıncıpal ınvestıgator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.

**Detailed Description:** Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.

Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.

### Conditions Module

**Conditions:**

- Nutrient Intake Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants needed nutrition from naso-enteric tube feeding are enrolled into this study. Double-blind was not needed here.

**Intervention Names:**

- Device: ultrathın esophagogastroduodenoscope

**Label:** Naso-enteric tube placement

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Naso-enteric tube placement

**Description:** Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity

**Name:** ultrathın esophagogastroduodenoscope

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The procedure times to place the tube are recorded

**Measure:** procedure time

**Time Frame:** wıthın 20 mınutes

#### Secondary Outcomes

**Description:** The tıme of the naso-enteric tube was recorded in day

**Measure:** the tıme of naso-enterıc tube usage

**Time Frame:** within 90 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Esophageal obstruction
2. Gastric outlet obstruction
3. Duodenal obstruction
4. Pancreatitis
5. Gastroparesis -

Exclusion Criteria:

* (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance

**Maximum Age:** 90 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** labyrinth68306830@icloud.com

**Name:** Jen S Lin, VS

**Phone:** 886-3-8561825

**Phone Ext:** 13224

**Role:** CONTACT

**Contact 2:**

**Email:** chitan.hu@msa.hinet.net

**Name:** Chi T Hu, VS

**Phone:** 886-3-8561825

**Phone Ext:** 13224

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hualien City

**Contacts:**

***Contact 1:***

- **Email:** labyrinth68306830@icloud.com

- **Name:** Jen S Lin, VS

- **Phone:** 886-3-8561825

- **Phone Ext:** 13224

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Tzu-chi Hospital

**State:** Hua-lien County

**Status:** RECRUITING

**Zip:** 97002

#### Overall Officials

**Official 1:**

**Affiliation:** Buddhist Tzu Chi General Hospital

**Name:** Jen S Lin, VS

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
