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To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction
Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracoabdominal approach | Experimental | Radical surgery should be finished via Thoracoabdominal approach. |
|
| Transhiatal/transabdominal approach | Active Comparator | Radical surgery should be finished via transhiatal/transabdominal approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transhiatal/transabdominal approach | Procedure | Radical surgery should be finished via transhiatal/transabdominal approach |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxin Wang, Dr | Contact | +8613811858199 | 301wxx@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35331180 | Derived | Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w. |
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| thoracoabdominal approach | Procedure | Radical surgery should be finished via thoracoabdominal approach |
|
| 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 |