Status:
RECRUITING
Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Esophagogastric Junction Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 internationa...
Eligibility Criteria
Inclusion
- Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II;
- Preoperative blood pressure controlled below 160/100 mmHg, blood glucose levels within 5.6 to 11.2 mmol/L, and normal functioning of major organs such as heart, lungs, liver, and kidneys. Main criteria include a Goldman cardiac risk index of grade 1 or 2; pulmonary function tests indicating predicted postoperative forced expiratory volume in 1 second (FEV1) \> 40%, and carbon monoxide diffusion capacity (DLCO) ≥ 40%; total bilirubin \< 1.5 times the upper limit of normal; Alanine amioTransferase (ALT) and Aspartate Transaminase (AST) \< 2.5 times the upper limit of normal; creatinine ≤ 1.25 times the upper limit of normal and creatinine clearance ≥ 60 mL/min;
- Enhanced thin-slice CT scan of the thorax and abdomen showing a tumor with a maximum diameter not exceeding 5 cm, and lymph nodes in the thorax and abdomen with a short diameter not exceeding 1 cm, clinically staged as CT1-2N0-1M0 (8th edition JACC staging);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- All relevant examinations completed within 14 days before surgery;
- Patients capable of understanding the study and providing informed consent by signing the consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06162767
Start Date
December 1 2023
End Date
June 30 2028
Last Update
March 21 2024
Active Locations (1)
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1
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China