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NCT Number: NCT06162767

Cancer of Esophagogastric Junction: Optimized Sweet Versus Ivor-Lewis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Louqian Zhang, MD

CONTACT

[email protected]

Rulin Zhuang, MD,PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperative diagnosis confirmed by esophagogastroduodenoscopy showing an Esophagogastric junction mass, with histopathological confirmation of malignancy, specifically Siewert Type II;
  • 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;
  • 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);
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
  • All relevant examinations completed within 14 days before surgery;
  • 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.

Treatment and study plan

Esophagectomy by Ivor-Lewis Procedure

Procedure

Esophagectomy was conducted by Ivor-Lewis Procedure.

Esophagectomy by Optimized Sweet Procedure

Procedure

Esophagectomy was conducted by Optimized Sweet Procedure.

Primary outcomes

  1. Disease Free Survival

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

  2. Postoperative morbidity

    Time frame: 3 years

  3. Postoperative mortality

    Time frame: 3 years

  4. locoregional recurrence

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Louqian Zhang, MD

CONTACT

[email protected]

+86-02556682004

Rulin Zhuang, MD, PhD

CONTACT

[email protected]

+86-02556682004

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Dec 8, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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