## Protocol Section
### Identification Module
**NCT ID:** NCT06412575

**Brief Title:** JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

**Official Title:** Joint Nasogastric Tube (JNT) Versus Traditional Decompression Nasogastric Tube (TNT) to Guided OGT-overlap Oesophagojejunostomy in Laparoscopic Total Gastrectomy: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** NFEC-2024-142
#### Organization
**Class:** OTHER
**Full Name:** Nanfang Hospital, Southern Medical University
### Status Module
#### Completion Date
**Date:** 2024-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanfang Hospital, Southern Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent laparoscopic total gastrectomy (LTG) were eligible for this study

**Detailed Description:** All patients enrolled in our study underwent standard laparoscopic total gastrectomy (LTG) with D2 lymphadenectomy and OGT-overlap oesophagojejunostomy according to the Japanese Gastric Cancer Association treatment guidelines and our previous reports. When the surgeons decided to perform OGT-overlap oesophagojejunostomy after gastrectomy, we randomised the patients into the Traditional Decompression Nasogastric Tube (TNT) group or Joint Nasogastric Tube (JNT) group by simple randomization operatively.

In the TNT group, the TNT was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophagealstump . While in the JNT group, the JNT was used to substitute the TNT. After the anastomosis was completed, the team of surgeons performed an intraoperative gastroscopy to check for defects, bleeding, and stenosis in the anastomosis, and esophageal pseudocanals, and also to confirm whether the esophageal mucosa was damaged by TNT or JNT.

### Conditions Module

**Conditions:**

- Gastric/Gastroesophageal Junction (g/Gej) Cancer

**Keywords:**

- Gastric tumor

- Gastric/gastroesophageal junction (G/GEJ)

- Laparoscopic total gastrectomy

- Overlap anastomosis

- Joint nasogastric tube

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study was a parallel, open-label randomized trial that aimed to assess safety and efficiency of JNT and TNT to guided OGT-overlap oesophagojejunostomy. Gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent LTG with OGT-overlap oesophagojejunostomy

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 108

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In the JNT group, the Joint Nasogastric Tube (JNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump.

**Intervention Names:**

- Procedure: JNT Guided OGT-overlap Oesophagojejunostomy

**Label:** JNT group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In the TNT group, the traditional decompression nasogastric tube (TNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump.

**Intervention Names:**

- Procedure: TNT Guided OGT-overlap Oesophagojejunostomy

**Label:** TNT group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JNT group

**Description:** In the JNT group, the Joint Nasogastric Tube (JNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump.

**Name:** JNT Guided OGT-overlap Oesophagojejunostomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- TNT group

**Description:** In the TNT group, the Traditional Decompression Nasogastric Tube (TNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump.

**Name:** TNT Guided OGT-overlap Oesophagojejunostomy

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** the oesophagealmucosa is observed endoscopically after the common hole is closed. Patients with esophageal mucosal injury can be shown as esophageal mucosal surface with mucosal injury caused by nasogastric tube (NT) .

**Measure:** Oesophageal mucosal injury

**Time Frame:** Surgery

**Description:** when inserting the anvil fork into the oesophagealhole, the anvil fork can be correctly placed in a satisfactory position and at a satisfactory angle into the oesophagealmucosa canal to be fired for oesophagojejunostomy by inserting it only once.

**Measure:** )Inserting anvil fork into oesophageallumen at first attempt

**Time Frame:** Surgery

**Description:** when inserting the NT from nose to the oesophagealstump only once without pulling out and reinserting.

**Measure:** Inserting NT to oesophagealstump at first attempt

**Time Frame:** Surgery

**Description:** postoperative complications were assessed within 30 days after the surgery and rated following Clavien-Dindo classification (CDC) system

**Measure:** Early postoperative complications

**Time Frame:** Within 30 days after the surgery

#### Primary Outcomes

**Description:** Time starts from insertion of the NT through the nose, to the end of the NT docking with the OGT and successfully implanted into the esophageal cavity.

**Measure:** Time of OGT and nasogastric tube (NT) connection

**Time Frame:** Surgery

#### Secondary Outcomes

**Description:** Time starts from insertion of the NT through the nose, to the front end of the NT reaching the esophageal stump.

**Measure:** Time of nasogastric tube (NT) insertion

**Time Frame:** Surgery

**Description:** Time starts from making the entry hole for the anastomosis on the oesophagealstump, to the end of the common entry hole was closed using barbed threads.

**Measure:** Time of oesophagojejunostomy

**Time Frame:** Surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

(1) Age 18-75 years; (2) Physical status score (ECOG) 0-2 points; (3) Preoperative pathological examination to diagnose gastric/gastroesophageal junction (G/GEJ) cancer; (4)No obvious contraindications for surgery; (5)Did not found metastasis preoperatively and intraoperatively; (6)Confirmed tumours invade oesophagus no more than 3cm intraoperatively; (7) Expected to perform OGT-overlap oesophagojejunostomy after lymphadenectomy and gastrectomy in the operation of laparoscopic total gastrectomy.

Exclusion Criteria:

(1)Underwent radiotherapy for G/GEJ cancer preoperatively; (2) continuous HIPEC after operation.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Nanfang Hospital, Southern Medical University

**State:** Guangdong

**Zip:** 510515

#### Overall Officials

**Official 1:**

**Affiliation:** Nanfang Hospital, Southern Medical University

**Name:** Xinhua Chen, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** If other researchers are interest in the IPD, please contact Xinhua Chen(xinhuachen03@163.com）.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
