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

STATUS

Recruiting
participants needed

94
sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Updated on 19 February 2024

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Summary

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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

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.;
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
Age	18years - 78years
Treatment	Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Clinical Study Identifier	NCT04423354
Sponsor	Guangdong Provincial Hospital of Traditional Chinese Medicine
Last Modified on	19 February 2024

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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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wei wang, M.D.,Ph.D

Primary Contact

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

China

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