Clinical trial NCT04423354: A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG
Official title: A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagogastric Junction Adenocarcinoma
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 junction.

Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ 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.

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 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.

Eligibility criteria: 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(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 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

Primary outcomes:
measure: The incidences of early perioperative complications
timeFrame: Within 30 days after surgery
measure: Perioperative mortality
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Duration of operation
timeFrame: From the beginning of anesthesia to the completion of surgery
measure: Intraoperative blood loss
timeFrame: From the beginning of anesthesia to the completion of surgery
measure: The rate of transit thoracotomy or laparotomy
timeFrame: From the beginning of anesthesia to the completion of surgery
measure: Intraoperative mortality
timeFrame: From the beginning of anesthesia to the completion of surgery
measure: Proximal marginal distance
timeFrame: From the beginning of anesthesia to the completion of surgery
measure: The number of mediastinal lymph node dissections and the positive
timeFrame: About 7 days.
measure: The number of abdominal lymph node dissections and the positive
timeFrame: About 7 days.
measure: The tumor type
timeFrame: About 7 days.
measure: The pathological stage
timeFrame: About 7 days.
measure: The duration of first exhaust
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of first defecation
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of first leaving the bed
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of restoration of full flow diet
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of restoration of half-flow diet
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of removal of chest drainage tube
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: The duration of postoperative hospitalization
timeFrame: Time from end of surgery to discharge,about 7 days.
measure: 3-year overall survival rate
timeFrame: 3 years after surgery
measure: 3-year disease-free survival rate
timeFrame: 3 years after surgery
measure: 5-year overall survival rate
timeFrame: 5 years after surgery
measure: 5-year disease-free survival rate
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong PHTCM
name: wei wang, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: