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Completed

NCT Number: NCT06412575

JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JNT Guided OGT-overlap Oesophagojejunostomy

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 Guided OGT-overlap Oesophagojejunostomy

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.

Primary outcomes

  1. 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

  1. Time of nasogastric tube (NT) insertion

    Time frame: Surgery

    Time starts from insertion of the NT through the nose, to the front end of the NT reaching the esophageal stump.

  2. Time of oesophagojejunostomy

    Time frame: Surgery

    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.

Other outcomes

  1. Oesophageal mucosal injury

    Time frame: Surgery

    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) .

  2. )Inserting anvil fork into oesophageallumen at first attempt

    Time frame: Surgery

    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.

  3. Inserting NT to oesophagealstump at first attempt

    Time frame: Surgery

    when inserting the NT from nose to the oesophagealstump only once without pulling out and reinserting.

  4. Early postoperative complications

    Time frame: Within 30 days after the surgery

    postoperative complications were assessed within 30 days after the surgery and rated following Clavien-Dindo classification (CDC) system

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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