Adenocarcinoma of Esophagogastric Junction
Conditions
Brief summary
To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
Detailed description
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.
Interventions
PROCEDUREtranshiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach
PROCEDUREthoracoabdominal approach
Radical surgery should be finished via thoracoabdominal approach
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival | 3 years after surgery | Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of R0-resection | About 10 days after surgery | The proportion of patients undergoing radical resection in all surgical patients |
| The incidences of early postoperative complications | Within 30 days after surgery | 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 (%). |
| The number of lymph node dissections and the positive | About 10 days after surgery | The number of lymph node dissections and the positive |
| The duration of postoperative hospitalization | Within 6 months after surgery | Time from end of surgery to discharge |
| The incidence of perioperative mortality | Within 30 days after surgery | The incidence of death due to the surgery |
Countries
China
Contacts
Primary ContactXinxin Wang, Dr
Outcome results
None listed