NCT06162767 Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis
| NCT ID | NCT06162767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Esophagogastric Junction Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-12-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or not.
Eligibility Criteria
Inclusion Criteria: 1. Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II; 2. 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; 3. 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); 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; 5. All relevant examinations completed within 14 days before surgery; 6. Patients capable of understanding the study and providing informed consent by signing the consent form. 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.
Contact & Investigator
Louqian Zhang, MD
PRINCIPAL INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Frequently Asked Questions
Who can join the NCT06162767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophagogastric Junction Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06162767 currently recruiting?
Yes, NCT06162767 is actively recruiting participants. Contact the research team at zhanglouqian@njmu.edu.cn for enrollment information.
Where is the NCT06162767 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06162767 clinical trial?
NCT06162767 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Louqian Zhang, MD at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 240 participants.