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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06412575
Enrollment
108
Registered
2024-05-14
Start date
2023-01-23
Completion date
2024-03-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric/Gastroesophageal Junction (g/Gej) Cancer

Keywords

Gastric tumor, Gastric/gastroesophageal junction (G/GEJ), Laparoscopic total gastrectomy, Overlap anastomosis, Joint nasogastric tube

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.

Interventions

PROCEDURETNT 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.

PROCEDUREJNT 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.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time of OGT and nasogastric tube (NT) connectionSurgeryTime 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.

Secondary

MeasureTime frameDescription
Time of oesophagojejunostomySurgeryTime 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.
Time of nasogastric tube (NT) insertionSurgeryTime starts from insertion of the NT through the nose, to the front end of the NT reaching the esophageal stump.

Other

MeasureTime frameDescription
Early postoperative complicationsWithin 30 days after the surgerypostoperative complications were assessed within 30 days after the surgery and rated following Clavien-Dindo classification (CDC) system
)Inserting anvil fork into oesophageallumen at first attemptSurgerywhen 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.
Oesophageal mucosal injurySurgerythe 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) .
Inserting NT to oesophagealstump at first attemptSurgerywhen inserting the NT from nose to the oesophagealstump only once without pulling out and reinserting.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026