Comparing two surgical procedures for esophagogastric junction cancer

A Randomized Controlled Study of Optimized Sweet Procedure Versus Ivor-Lewis Procedure Esophagectomy in Adenocarcinoma of Esophagogastric Junction

This study is testing whether a new surgical method for treating esophagogastric junction cancer helps patients recover better and have fewer complications than the traditional surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06162767 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with Siewert Type II esophagogastric junction carcinoma who meet specific preoperative health criteria.

Not a fit: Patients with advanced disease stages or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with esophagogastric junction cancer.

How similar studies have performed: While traditional surgical approaches have been well-studied, the Optimized Sweet Procedure represents a novel application of minimally invasive techniques in this context.

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.

Where this trial is running

Nanjing, Jiangsu

• 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

Conditions: Esophagogastric Junction Carcinoma