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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    94
  • sponsor
    Guangdong Provincial Hospital of Traditional Chinese Medicine
Updated on 25 January 2021

Summary

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

Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

Primary study endpoints: The incidences of early postoperative complications and mortality.

The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.

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 mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;
  2. Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.

Details
Condition Siewert Type II Adenocarcinoma of Esophagogastric Junction, Esophagogastric Junction Adenocarcinoma
Treatment Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Clinical Study IdentifierNCT04423354
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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(Siewert)
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 Criteria

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
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