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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.

Physical status and organ function allow robotic-assisted partial nephrectomy.

Be able to adhere to the protocol during the study.

The age ranges from 18 to 75 years, and there is no chronic kidney disease.

Disqualifiers

Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.

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

Organ transplant recipients requiring immunosuppressive therapy.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative three-dimensional reconstruction

    Diagnostic test

    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.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: 3D trial groupExperimental treatment 1 intervention
Group B: Conventional groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

warm ischemia time

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.

Time frame
From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.

Secondary outcomes

1

operative time

Time frame
From the beginning to the end of the surgery, an average of 3 hours.
2

Intraoperative bleeding

Time frame
From the beginning to the end of the surgery, an average of 3 hours.
3

Length of postoperative hospital stay

Time frame
an average of a week.
4

Incidence of postoperative complications

Time frame
an average of a week.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Sir Run Run Shaw Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Peking University First Hospital

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

The Second Affiliated Hospital of Dalian Medical University

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Qilu Hospital of Shandong University

Collaborator

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

West China Hospital

Collaborator

Tongji Hospital

Collaborator

Sun Yat-sen University Tumor Hospital

Collaborator

Shanghai Cancer Hospital, China

Collaborator

Shengjing Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: