JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

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

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

Study Overview

• Status: Completed
• Conditions: Gastric/Gastroesophageal Junction (g/Gej) Cancer
• Intervention / Treatment: Procedure: JNT Guided OGT-overlap Oesophagojejunostomy; Procedure: TNT Guided OGT-overlap Oesophagojejunostomy

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNT group; 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.	Procedure: JNT Guided OGT-overlap Oesophagojejunostomy; 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.
Active Comparator: TNT group; 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.	Procedure: TNT Guided OGT-overlap Oesophagojejunostomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of OGT and nasogastric tube (NT) connection	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.	Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of nasogastric tube (NT) insertion	Time starts from insertion of the NT through the nose, to the front end of the NT reaching the esophageal stump.	Surgery
Time of oesophagojejunostomy	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.	Surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oesophageal mucosal injury	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) .	Surgery
)Inserting anvil fork into oesophageallumen at first attempt	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.	Surgery
Inserting NT to oesophagealstump at first attempt	when inserting the NT from nose to the oesophagealstump only once without pulling out and reinserting.	Surgery
Early postoperative complications	postoperative complications were assessed within 30 days after the surgery and rated following Clavien-Dindo classification (CDC) system	Within 30 days after the surgery

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Xinhua Chen, Ph.D, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic total gastrectomy; Gastric tumor; Gastric/gastroesophageal junction (G/GEJ); Overlap anastomosis; Joint nasogastric tube
• Other Study ID Numbers: NFEC-2024-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If other researchers are interest in the IPD, please contact Xinhua Chen(xinhuachen03@163.com）.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No