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

Guangdong Provincial Hospital of Traditional Chinese Medicine94 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric JunctionPROCEDURE

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 by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidences of early perioperative complications

The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.

Time frame: Within 30 days after surgery

Perioperative mortality

The incidence of death due to the surgery

Time frame: Within 30 days after surgery

Secondary Outcomes

Duration of operation

The time it takes to complete the operation

Time frame: From the beginning of anesthesia to the completion of surgery

Intraoperative blood loss

Total blood lost during surgery

Time frame: From the beginning of anesthesia to the completion of surgery

The rate of transit thoracotomy or laparotomy

Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.

Time frame: From the beginning of anesthesia to the completion of surgery

Intraoperative mortality

The rate of death during the surgery.

Time frame: From the beginning of anesthesia to the completion of surgery

Proximal marginal distance

The length of proximal tumor from esophageal resection margin.

Time frame: From the beginning of anesthesia to the completion of surgery

The number of mediastinal lymph node dissections and the positive

The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.

Time frame: About 7 days.

The number of abdominal lymph node dissections and the positive

The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.

Time frame: About 7 days.

The tumor type

Such as squamous cell carcinoma, adenocarcinoma, etc.

Time frame: About 7 days.

The pathological stage

Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer

Time frame: About 7 days.

The duration of first exhaust

The duration from the end of the operation to the first exhaust after the operation.