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Clinical Trials/NCT06412575
NCT06412575CompletedNot Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country108 target enrollmentStarted: January 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
108
Locations
1
Primary Endpoint
Time of OGT and nasogastric tube (NT) connection

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Time of OGT and nasogastric tube (NT) connection

Time Frame: Surgery

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.

Secondary Outcomes

  • Time of nasogastric tube (NT) insertion(Surgery)
  • Time of oesophagojejunostomy(Surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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