Comparing two surgical procedures for esophagogastric junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Optimized Sweet Procedure compared to the traditional Ivor-Lewis Procedure for patients with esophagogastric junction carcinoma. The study will enroll 240 patients and utilize a randomized controlled design to assess long-term outcomes and postoperative complications. By leveraging minimally invasive techniques, the Optimized Sweet Procedure seeks to reduce surgical trauma and improve recovery times. Postoperative follow-ups will track quality of life, mortality rates, and other critical indicators over five years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Louqian Zhang, MD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Louqian Zhang, MD
• Email: zhanglouqian@njmu.edu.cn
• Phone: +86-02556682004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.