Status:

UNKNOWN

A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG

Lead Sponsor:

Guangdong Provincial Hospital of Traditional Chinese Medicine

Conditions:

Esophagogastric Junction Adenocarcinoma

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Eligibility:

All Genders

18-78 years

Phase:

NA

Brief Summary

Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junctio...

Detailed Description

1. Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of ...

Eligibility Criteria

Inclusion

  • Informed consent of patients;
  • The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
  • The endoscopic biopsy was diagnosed with adenocarcinoma;
  • Preoperative clinical staging was cT1-4aNanyM0
  • No distant metastasis and invasion of surrounding organs were found;
  • ECOG score ranged from 0 to 1;
  • ASA score ranged from I to III.

Exclusion

  • Pregnant or lactating women
  • Have a severe mental illness
  • History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
  • History of other malignant tumors within 5 years
  • History of unstable angina pectoris or myocardial infarction within 6 months
  • FEV1% of pulmonary function test was less than 50% of expected value
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • Have severe liver and kidney damage

Key Trial Info

Start Date :

March 25 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2024

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT04423354

Start Date

March 25 2019

End Date

March 31 2024

Last Update

June 9 2020

Active Locations (1)

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Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China, 510120