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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction; Esophagogastric Junction Adenocarcinoma

Treatments: Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction

Study type: Interventional

Funder types: Other

Identifiers

NCT04423354

WWang

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

94 participants in 1 patient group

Research group

Experimental group

Description:

Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.

Treatment:

Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction