Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

Study Overview
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Brief Summary
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To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Detailed Description
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Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ adenocarcinoma of esophagogastric junction. Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed. The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

Official Title
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A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction

Conditions
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Adenocarcinoma of Esophagogastric Junction

Intervention / Treatment
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* Procedure: transhiatal/transabdominal approach
* Procedure: thoracoabdominal approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 75 years old 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) . 3.Histological diagnosis of adenocarcinoma 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3 5.Informed consent of patients Exclusion Criteria: 1.Patients with distant metastasis (M1) or invasion of surrounding organs 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer) 3.History of other malignant tumors within 5 years 4.The researcher believes that the patient is not suitable to participate in the clinical trial 5.Patients who persist in withdrawing from clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracoabdominal approach<br>Radical surgery should be finished via Thoracoabdominal approach. | Procedure: thoracoabdominal approach<br>* Radical surgery should be finished via thoracoabdominal approach<br>|
| Active Comparator: Transhiatal/transabdominal approach<br>Radical surgery should be finished via transhiatal/transabdominal approach. | Procedure: transhiatal/transabdominal approach<br>* Radical surgery should be finished via transhiatal/transabdominal approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival | Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of R0-resection | The proportion of patients undergoing radical resection in all surgical patients | About 10 days after surgery | 
| The number of lymph node dissections and the positive | The number of lymph node dissections and the positive | About 10 days after surgery | 
| The duration of postoperative hospitalization | Time from end of surgery to discharge | Within 6 months after surgery | 
| The incidences of early postoperative complications | The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%). | Within 30 days after surgery | 
| The incidence of perioperative mortality | The incidence of death due to the surgery | Within 30 days after surgery |