Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal… (NCT05790122) | Clinical Trial Compass
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Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal Carcinoma
China146 participantsStarted 2022-12-01
Plain-language summary
Partial nephrectomy(PN) and tumor enucleation(TE) are the two main methods of Nephron-sparing surgery for early renal cell carcinoma. Because of its blunt separation, TE is often considered to be difficult to completely remove tumor tissue. In addition, compared with PN, TE is more difficult and has higher professional requirements for surgeons. Therefore most surgeons use PN. But Many studies have shown that TE has advantages over PN such as less trauma, faster recovery, and better protection of renal function without increasing the risk of tumor recurrence.
The main renal artery should be clamped during PN to achieve a relatively bloodless operation environment to ensure the safety of tumor resection. However, too long warm ischemia time will inevitably affect the function of normal renal tissue. Studies have shown that shortening the time of renal ischemia is closely related to the recovery of renal function after the operation. So reducing the time of warm ischemia until zero ischemia has become the pursuit of surgeons. Based on renal cell carcinoma resection combined with zero ischemia technique, renal parenchyma, and renal function can be protected to the maximum extent on the premise of ensuring tumor safety.
The purpose of this study is to explore the safety and efficacy of zero-ischemia TE by analyzing the data of early renal cell carcinoma patients who had undergone PN and zero-ischemia TE before.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operation time
Timeframe: Period of surgery
2
Estimated blood loss
Timeframe: Period of surgery
3
Positive rate of incision margin
Timeframe: Period of surgery
4
Serum creatinine
Timeframe: Pre-operative, 1 day after the surgery and monthly follow-up in one year
Trial details
NCT IDNCT05790122
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine