Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis

NCT ID: NCT06162767

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2028-06-30

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.

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 international guidelines advocate for a comprehensive approach primarily centered around surgical intervention for the management of esophagogastric junction carcinoma. This preference stems from the fact that lymph node metastasis in such patients can occur simultaneously in the abdominal region and the lower mediastinum. Consequently, conventional options like the Ivor Lewis and Sweet procedures are routinely recommended due to their capability to encompass tumor resection, margin clearance, and lymph node dissection. However, traditional Sweet procedures are associated with higher surgical trauma and increased postoperative complications. With the evolution of single-incision thoracoscopy, we have leveraged the advantages of minimally invasive techniques and innovatively devised an Optimized "totally thoracoscopic Sweet procedure".In this study, a randomized controlled trial will enroll 240 patients diagnosed with esophagogastric junction carcinoma to compare the therapeutic efficacy between the Optimized Sweet Procedure and the Ivor-Lewis Procedure. Postoperative follow-ups will be conducted to analyze pre-discharge indicators and five-year postoperative outcomes, examining the correlation between the two surgical procedures in terms of postoperative quality of life, mortality rates, and survival rates, aiming to explore whether the Optimized Sweet Procedure is superior to the Ivor-Lewis Procedure Esophagectomy.

Conditions

Esophagogastric Junction Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ivor-Lewis Procedure

Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach: Ivor-Lewis Procedure.

Group Type: ACTIVE_COMPARATOR

Esophagectomy by Ivor-Lewis Procedure

Intervention Type: PROCEDURE

Esophagectomy was conducted by Ivor-Lewis Procedure.

Optimized Sweet Procedure

Arm B: Esophagectomy was conducted by single-incision thoracoscope combined with laparoscopy with the patient in a right oblique side position at 45 degrees: Optimized Sweet Procedure.

Group Type: ACTIVE_COMPARATOR

Esophagectomy by Optimized Sweet Procedure

Intervention Type: PROCEDURE

Esophagectomy was conducted by Optimized Sweet Procedure.

Interventions

Esophagectomy by Ivor-Lewis Procedure

Esophagectomy was conducted by Ivor-Lewis Procedure.

Intervention Type: PROCEDURE

Esophagectomy by Optimized Sweet Procedure

Esophagectomy was conducted by Optimized Sweet Procedure.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louqian Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Louqian Zhang, MD

Role: CONTACT

zhanglouqian@njmu.edu.cn

+86-02556682004

Rulin Zhuang, MD, PhD

Role: CONTACT

Rulinzhuang@njmu.edu.cn

+86-02556682004

Facility Contacts

Louqian Zhang, MD

Role: primary

zhanglouqian@njmu.edu.cn

Rulin Zhuang, MD,PhD

Role: backup

rulinzhuang@njmu.edu.cn

Other Identifiers

2023-186-02

Identifier Type: -

Identifier Source: org_study_id