Evaluating a new method for kidney tumor removal without sutures or blood flow interruption
Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal Carcinoma
This study tests a new way to remove kidney tumors without stitches or stopping blood flow to see if it helps patients recover faster and stay safe compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT05790122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of a sutureless zero ischemia laparoscopic technique for enucleating T1 stage renal cell carcinoma tumors. By comparing this method with traditional partial nephrectomy and other techniques, the researchers will analyze data collected from patients who underwent these procedures between 2014 and 2022. The study focuses on understanding the benefits of reducing ischemia time and improving recovery while maintaining tumor removal effectiveness. The findings will help identify which patients may benefit most from this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with T1a or T1b renal cell carcinoma who have undergone specific surgical procedures.
Not a fit: Patients with severe comorbidities or those whose tumors are anatomically unsuitable for enucleation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive kidney surgeries with quicker recovery times and better preservation of kidney function.
How similar studies have performed: While there have been studies on tumor enucleation, this specific approach of sutureless zero ischemia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. The age is between 18 and 80 years old. * 2. Patients with T1a or T1b renal cell carcinoma according to TNM staging of AJCC renal cell carcinoma, 8th edition, 2017. * 3. Patients who underwent unclamped renal tumor enucleation or partial nephrectomy between 2014 and 2022. Exclusion Criteria: * 1. The patients accompanied by severe active infection or severe diseases of heart, liver, kidney and hematopoietic system. And with other conditions that are not suitable for related tests. * 2. The patient has no measurable or evaluable lesions. * 3. The tumor is close to the collection system and touches the renal artery or renal vein. And other anatomy of tumor is not suitable for tumor enucleation. * 4. History of organ transplantation or need long-term adrenocortical hormone therapy. Hypothyroidism, adrenal or pituitary dysfunction that cannot be controlled by hormone replacement therapy alone. type I diabetes mellitus, psoriasis or vitiligo that require systematic treatment, etc. * 5. Active infection requiring systemic treatment. Human immunodeficiency virus (HIV) infection (known HIV antibody positive). Active HBV or HCV infection (HBsAg positive, or HBcAb positive but HBsAg negative, additional testing is required Quantitative DNA, the result does not exceed the upper limit of the laboratory normal value of the research center can participate in this study; the HCV RNA test result of the previous HCV infection screening period is negative, can participate in this study) * 6. Patients have history of kidney surgery or any history of kidney inflammation surgery. Patients have kidney cancer related to urinary collection system and have other kidney diseases (including kidney stone glomerulonephritis)
Where this trial is running
Yiwu, Zhejiang
- The Fourth Affiliated Hospital Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yichun Zheng, Doctor
- Email: springworld@yeah.net
- Phone: 0571-87783550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.