NCT05790122

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

February 28, 2023

Last Update Submit

March 27, 2023

Conditions

Carcinoma, Renal CellKidney Neoplasms

Keywords

Renal cell carcinomaZero ischemiaUnclamped tumor enucleationSmall renal massSutureless

Outcome Measures

Primary Outcomes (4)

  • Operation time

    Operation time

    Period of surgery

  • Estimated blood loss

    The estimated blood loss of operation

    Period of surgery

  • Positive rate of incision margin

    Positive rate of incision margin

    Period of surgery

  • Serum creatinine

    Serum creatinine of patients before and after operation and follow-up

    Pre-operative, 1 day after the surgery and monthly follow-up in one year

Study Arms (2)

Group PN

The patients undergoing partial nephrectomy.

Group TE

The patients undergoing renal tumor enucleation.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with early renal carcinoma who have undergone partial nephrectomy or tumor enucleation.

You may qualify if:

  • \. The age is between 18 and 80 years old.
  • \. Patients with T1a or T1b renal cell carcinoma according to TNM staging of AJCC renal cell carcinoma, 8th edition, 2017.
  • \. Patients who underwent unclamped renal tumor enucleation or partial nephrectomy between 2014 and 2022.

You may not qualify if:

  • \. 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.
  • \. The patient has no measurable or evaluable lesions.
  • \. 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.
  • \. 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.
  • \. 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)
  • \. 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Related Publications (2)

  • Wu X, Chen W, Huang J, Zhang J, Liu D, Huang Y, Chen Y, Xue W. Zero ischemia laparoscopic microwave ablation assisted enucleation vs. laparoscopic partial nephrectomy in clinical T1a renal tumor: a randomized clinical trial. Transl Cancer Res. 2020 Jan;9(1):194-202. doi: 10.21037/tcr.2019.12.73.

    PMID: 35117173RESULT

  • Xu C, Jiang Y, Du J, Yang K, Zhong Q, Liu D, Zhang C, Zheng Y. Three-dimensional reconstruction-guided modified arterial-based complexity scoring system for nephron-sparing surgery: comparative outcomes of on-clamp and off-clamp tumor enucleation in renal cell carcinoma. Front Surg. 2025 Nov 6;12:1683222. doi: 10.3389/fsurg.2025.1683222. eCollection 2025.

    PMID: 41282560DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Yichun Zheng, Doctor

    The Fourth Affiliated Hospital Zhejiang University School of Medicine

    STUDY CHAIR

Central Study Contacts

Yichun Zheng, Doctor

CONTACT

0571-87783550springworld@yeah.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 30, 2023

Study Start

December 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)