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JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

N

Nanfang Hospital, Southern Medical University

Status

Completed

Conditions

Gastric/Gastroesophageal Junction (g/Gej) Cancer

Treatments

Procedure: JNT Guided OGT-overlap Oesophagojejunostomy
Procedure: TNT Guided OGT-overlap Oesophagojejunostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06412575
NFEC-2024-142

Details and patient eligibility

About

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

Full 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.

Enrollment

108 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

JNT group
Experimental 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.
Treatment:
Procedure: JNT Guided OGT-overlap Oesophagojejunostomy
TNT group
Active Comparator 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.
Treatment:
Procedure: TNT Guided OGT-overlap Oesophagojejunostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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