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

Summary

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.

Conditions

• Kidney Neoplasms / Surgery
• Robotic Surgical Procedures
• Imaging, Three-Dimensional / Methods
• Nephrectomy / Methods

Interventions

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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Sun Yat-sen University Tumor Hospital

  collaborator UNKNOWN

• Shanghai Cancer Hospital, China

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-09-30

Completion

2027-10-31

FDA Device

Yes

Countries

• China

Study Locations