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

Study Overview
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Brief 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 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
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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.

Official Title
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A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction

Conditions
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Esophagogastric Junction Adenocarcinoma, Siewert Type II Adenocarcinoma of Esophagogastric Junction

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research group<br>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. | Procedure: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 30 days after surgery | 
| Perioperative mortality | The incidence of death due to the surgery | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | The time it takes to complete the operation | From the beginning of anesthesia to the completion of surgery | 
| Intraoperative blood loss | Total blood lost during surgery | 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. | From the beginning of anesthesia to the completion of surgery | 
| Intraoperative mortality | The rate of death during the surgery. | From the beginning of anesthesia to the completion of surgery | 
| Proximal marginal distance | The length of proximal tumor from esophageal resection margin. | 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. | 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. | About 7 days. | 
| The tumor type | Such as squamous cell carcinoma, adenocarcinoma, etc. | About 7 days. | 
| The pathological stage | Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer | About 7 days. | 
| The duration of first exhaust | The duration from the end of the operation to the first exhaust after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of first defecation | The duration from the end of the operation to the first defecation after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of first leaving the bed | The duration from the end of the operation to the first leaving the bed after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of restoration of full flow diet | The duration from the end of the operation to restore to a full-flow diet after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of restoration of half-flow diet | The duration from the end of the operation to restore to a half-flow diet after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of removal of chest drainage tube | The duration from the end of the operation to remove the chest drainage tube after the operation. | Time from end of surgery to discharge,about 7 days. | 
| The duration of postoperative hospitalization | The duration from the end of the operation to hospital discharge. | Time from end of surgery to discharge,about 7 days. | 
| 3-year overall survival rate | Overall survival rate during 3 years after surgery | 3 years after surgery | 
| 3-year disease-free survival rate | Disease-free survival rate during 3 years after surgery | 3 years after surgery | 
| 5-year overall survival rate | Overall survival rate during 5 years after surgery | 5 years after surgery | 
| 5-year disease-free survival rate | Disease-free survival rate during 5 years after surgery | 5 years after surgery |