A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.

November 29, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

A Prospective, Multicenter, Randomized Controlled Study of Three-dimensional Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors

The goal of this clinical trial is to learn the evidence-based medical value of 3D visualization techniques to improve tumor control, preservation of renal function, and perioperative safety in robot-assisted nephron sparing surgery for complex renal tumors. The main question it aims to answer is:

Is 3D visualization techniques more effective in improving robot-assisted nephron sparing surgery for complex renal tumors in terms of tumor control, renal function preservation, and perioperative safety.

The researchers will randomize participants into a 3D trial group and a conventional group for comparison.

Participants will:

Complete Blood routine, liver and kidney function tests on the first and third day after operation.

Have Renography at 3 and 12 months after the operation. Cooperate with follow-up visits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Sample size:

    When designing this experiment, considering the warm ischemic time reported by our center and in the literature, with a test power of 80% (β= 0.2), a power value of 0.8, a one-sided type I error of 2.5% (α= 0.05), the sample size is calculated to be 242 cases. The enrollment is planned to last 2 years, and the follow-up results from enrollment to the initial stage are for 5 years. Calculated based on a 30% dropout rate, 350 cases are planned to be enrolled.

  2. Enrollment screening:

    Appropriate, reproducible methods should be used to evaluate the tumor prior to randomization (e.g., CT and/or MRI). The following evaluations should be made prior to randomization: demographic data, medical history (including concomitant disease and treatments), physical examination, pregnancy test (if necessary), special examinations (chest X-ray and ECG).

    The following evaluations should be made prior to randomization: vital signs and physical examination (including Karnofsky performance status score, height, and weight), hematological and biochemical examinations.

  3. Randomization:

    Patients who meet the selection criteria will be randomly allocated to the 3D trial group and the conventional group in a 1:1 ratio.

  4. Assessment During the Study Period:

    During the study period, patients' concomitant disease and treatments will be continuously monitored, and vital signs, weight, Karnofsky performance status score, hematological examinations (including white blood cells/neutrophils), and serum biochemical examinations will be conducted according to specified time intervals for each patient. An conventional ECG and chest X-ray/CT examination will be conducted prior to surgery. Tumor assessment will be conducted during the perioperative period (clinical examination, chest X-ray or chest CT/MRI, and abdominal CT/MRI). Laboratory examination indicators during the perioperative period should be recorded, such as preoperative and postoperative hematological and biochemical examinations. The focus is to complete the renogram to evaluate renal function within 1 month prior to surgery, and re-evaluating renal function with a renogram 3 months and 12 months after surgery to assess changes in renal function. No matter what surgical method is used, detailed records should be made of what was seen during the operation, the surgical method, operative data, and postoperative pathology. All patients should be followed up according to the study protocol, and PFS and OS should be recorded.

  5. Statistical Analysis:

Statistical analysis will be conducted using the SPSS 24.0 software package. Statistical descriptions will use rates for enumeration data, and means and 95% confidence intervals for measurement data. The t-test will be used to compare the measurement data between the two groups, the Chi-square test will be used to analyze the enumeration data, the Kaplan-Meier method will be used to calculate the survival curve, and the Log-rank test will be used to compare the two treatments.HR and 95% Confidence intervals for survival in subgroups will be determined with the multiple individual Cox models, which will separately measure the interaction between factors and treatment effect. The probability P value will be used for statistical inference regardless of the stage, and the statistically significant difference thresholds will be adopted as 0.05.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
        • Principal Investigator:
          • Xin Yao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.
  2. Physical status and organ function allow robotic-assisted partial nephrectomy.
  3. Be able to adhere to the protocol during the study.
  4. The age ranges from 18 to 75 years, and there is no chronic kidney disease.
  5. KPS > 80; ECOG score: 0-1; There are no other serious concomitant diseases and the organ function is good.
  6. There are no medical contraindications seriously affecting anesthesia and surgery.
  7. The patient has no history of other malignant tumors in the past 5 years.
  8. There is no surgical history of epigastrium and the affected kidney.
  9. Estimated survival is more than 6 months, and there are no other severe diseases that reduce survival to less than 5 years.

Exclusion Criteria:

  1. Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
  2. Comorbid serious medical diseases or conditions, for example, clinically severe or active heart disease, severe uncontrolled medical illnesses and infections, severe uncontrolled digestive disorder, severe electrolyte disturbance, active disseminated intravascular coagulation, major organ failure such as decompensated cardiac, pulmonary, hepatic, or renal failure, symptomatic peripheral neuropathy. Can not tolerate robot-assisted laparoscopic partial nephrectomy
  3. Organ transplant recipients requiring immunosuppressive therapy.
  4. There is history of other malignancies within 5 years of trial initiation, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
  5. Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
  6. Patients with multiple or bilateral renal tumors or solitary renal tumors.
  7. Patient without complete clinical information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D trial group
The three-dimensional reconstruction data of patients will be synthesized according to renal enhanced CT/MRI within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the three-dimensional reconstruction and perform robot-assisted laparoscopic nephron sparing surgery.
Diagnostic test: Preoperative three-dimensional reconstruction
On the basis of conventional CT/MRI, the patient will undergo 3D reconstruction within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the 3D reconstruction and perform robot-assisted laparoscopic nephron sparing surgery.
No Intervention: Conventional group
The patients will not undergo preoperative 3D reconstruction. The surgeon will arrange robot-assisted laparoscopic nephron sparing surgery according to routine CT/MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
warm ischemia time
Time Frame: From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.
The time from start of arterial clamping to release of arterial blocking forceps during surgery. Superselective arterial blockade will be recorded separately as a specific blockade modality. The arterial blocking time will be recorded as 0 for those without arterial blockage.
From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: From the beginning to the end of the surgery, an average of 3 hours.
From the beginning to the end of the surgery, an average of 3 hours.
Intraoperative bleeding
Time Frame: From the beginning to the end of the surgery, an average of 3 hours.
From the beginning to the end of the surgery, an average of 3 hours.
Length of postoperative hospital stay
Time Frame: an average of a week.
an average of a week.
Incidence of postoperative complications
Time Frame: an average of a week.
an average of a week.
Positive rate of pathological margin
Time Frame: an average of a week.
an average of a week.
Conversion rate
Time Frame: From the beginning to the end of the surgery, an average of 3 hours.
Laparoscopic surgery converts to open surgery, or partial nephrectomy converts to radical nephrectomy during the surgery.
From the beginning to the end of the surgery, an average of 3 hours.
Postoperative creatinine changes
Time Frame: 1 month
1 month
Changes in glomerular filtration rate
Time Frame: 3 month.
3 month.
3-year recurrence-free survival rate
Time Frame: Within three years from the end of the surgery.
Within three years from the end of the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Peking University First Hospital
West China Hospital
Qilu Hospital of Shandong University
The First Affiliated Hospital of Zhengzhou University
Hebei Medical University Fourth Hospital
Shanghai Cancer Hospital, China
First Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Dalian Medical University
Liaoning Cancer Hospital & Institute
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Sir Run Run Shaw Hospital, Zhejiang University
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China
Shengjing hospital affiliated to China Medical University
Sun Yat-sen University Tumor Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20241351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Robotic Surgical Procedures

Clinical Trials on Preoperative three-dimensional reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe