JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-03-31

Brief Summary

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

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Detailed Description

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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

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Gastric/Gastroesophageal Junction (g/Gej) Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

JNT Guided OGT-overlap Oesophagojejunostomy

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

TNT Guided OGT-overlap Oesophagojejunostomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.