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Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type â…¡ adenocarcinoma of esophagogastric junction.
Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research group | Experimental | Patients diagnosed with Siewert â…¡ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type â…¡ Adenocarcinoma of Esophagogastric Junction | Procedure | Patients diagnosed with Siewert â…¡ 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei wang, M.D.,Ph.D | Contact | +86-13922255515 | ww1640@yeah.net | |
| yuling xue, M.M. | Contact | +86-15014167320 | xueyuling1994@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| wei wang, M.D.,Ph.D | Guangdong PHTCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
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|
| 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 |