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This study is being done to see whether Optimized Sweet Procedure is superior than the Ivor-Lewis Procedure Esophagectomy with better long-term outcome and acceptable postoperative short-term outcome or not.
Esophagogastric junction carcinoma is a prevalent malignancy within the human digestive system, ranking as the sixth leading cause of cancer-related deaths worldwide. Current national and international guidelines advocate for a comprehensive approach primarily centered around surgical intervention for the management of esophagogastric junction carcinoma. This preference stems from the fact that lymph node metastasis in such patients can occur simultaneously in the abdominal region and the lower mediastinum. Consequently, conventional options like the Ivor Lewis and Sweet procedures are routinely recommended due to their capability to encompass tumor resection, margin clearance, and lymph node dissection. However, traditional Sweet procedures are associated with higher surgical trauma and increased postoperative complications. With the evolution of single-incision thoracoscopy, we have leveraged the advantages of minimally invasive techniques and innovatively devised an Optimized "totally thoracoscopic Sweet procedure".In this study, a randomized controlled trial will enroll 240 patients diagnosed with esophagogastric junction carcinoma to compare the therapeutic efficacy between the Optimized Sweet Procedure and the Ivor-Lewis Procedure. Postoperative follow-ups will be conducted to analyze pre-discharge indicators and five-year postoperative outcomes, examining the correlation between the two surgical procedures in terms of postoperative quality of life, mortality rates, and survival rates, aiming to explore whether the Optimized Sweet Procedure is superior to the Ivor-Lewis Procedure Esophagectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivor-Lewis Procedure | Active Comparator | Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach: Ivor-Lewis Procedure. |
|
| Optimized Sweet Procedure | Active Comparator | Arm B: Esophagectomy was conducted by single-incision thoracoscope combined with laparoscopy with the patient in a right oblique side position at 45 degrees: Optimized Sweet Procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy by Ivor-Lewis Procedure | Procedure | Esophagectomy was conducted by Ivor-Lewis Procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Postoperative morbidity | 3 years | |
| Postoperative mortality |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have undergone prior anti-tumor therapy (such as radiotherapy, chemotherapy, immunotherapy, etc.) before surgery; individuals with a history of other malignancies; patients presenting with secondary primary cancer at the time of enrollment; those with a history of prior unilateral thoracic or abdominal major surgeries; pregnant or lactating women; individuals with interstitial pneumonia, pulmonary fibrosis, or severe emphysema; uncontrolled infections; severe mental illness; and those with a history of severe heart disease, congestive heart failure, myocardial infarction, or angina attacks within the last six months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louqian Zhang, MD | Contact | +86-02556682004 | zhanglouqian@njmu.edu.cn | |
| Rulin Zhuang, MD, PhD | Contact | +86-02556682004 | Rulinzhuang@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Louqian Zhang, MD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | China |
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| Esophagectomy by Optimized Sweet Procedure | Procedure | Esophagectomy was conducted by Optimized Sweet Procedure. |
|
| 3 years |
| locoregional recurrence | 5 years |