Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two surgical methods to treat cancer located at the junction of the esophagus and stomach, known as esophagogastric junction carcinoma. The study is comparing the "Optimized Sweet Procedure" with the traditional "Ivor-Lewis Procedure" to see which one leads to better long-term recovery and acceptable short-term results for patients. The trial is currently looking for participants aged 65 to 74, and it welcomes individuals of all genders who meet specific health criteria.

To be eligible for this trial, participants must have a confirmed diagnosis of a specific type of cancer in the esophagogastric junction, and their overall health must be stable, with controlled blood pressure and normal functioning of key organs like the heart and lungs. Prospective participants should also be able to understand the study and provide consent to join. If you or a loved one qualify for this study, you can expect to undergo surgery and be closely monitored for recovery and health outcomes. It's important to know that certain conditions, such as previous cancer treatments or major surgeries, may prevent someone from participating in this trial.

Gender

ALL

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.