A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- 3-year disease-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Thoracoabdominal approach
Radical surgery should be finished via Thoracoabdominal approach.
Intervention: thoracoabdominal approach (Procedure)
Transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach.
Intervention: transhiatal/transabdominal approach (Procedure)
Outcomes
Primary Outcomes
3-year disease-free survival
Time Frame: 3 years after surgery
Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up
Secondary Outcomes
- The incidence of perioperative mortality(Within 30 days after surgery)
- The rate of R0-resection(About 10 days after surgery)
- The number of lymph node dissections and the positive(About 10 days after surgery)
- The duration of postoperative hospitalization(Within 6 months after surgery)
- The incidences of early postoperative complications(Within 30 days after surgery)
Investigators
Lin Chen
Prof.
Chinese PLA General Hospital