Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

Summary

A proposed new tool ('DIPLANN-tool' - Digital Planning in Nephrectomy) for predicting kidney perfusion zones on a segmented 3D model during robot-assisted partial nephrectomy (RAPN) for localized renal cancer demonstrated high accuracy when planning selective clamping (SC) for RAPN. However, the tool's clinical added value still needs to be confirmed. Therefore, a randomized controlled trial using a study and control group is the preferred study design.

Experimental group: the use of the DIPLANN-tool + conventional computed tomography (CT) imaging for preoperative planning and perioperative guidance during RAPN.

Control group: the use of only conventional CT imaging for preoperative planning and perioperative guidance during RAPN (= current standard of care).

The primary endpoint is planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.

Conditions

• Kidney Cancer
• Kidney Neoplasms
• Kidney Diseases
• Renal Cancer
• Renal Cell Carcinoma
• Renal Disease

Interventions

DEVICE

Pre-operative explanation of the procedure (DIPLANN + CT)

Pre-operative study visit explaining the RAPN procedure using the 3D model / DIPLANN-tool (with or without classical CT imaging). Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.

DEVICE

Pre-operative surgical planning (DIPLANN + CT)

Online assessment by surgeon regarding clamping strategy. Assisted by DIPLANN-tool + CT scan.

PROCEDURE

RAPN (DIPLANN + CT)

Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by DIPLANN-tool + CT scan.

DEVICE

Pre-operative explanation of the procedure (CT only)

Pre-operative study visit explaining the RAPN procedure using CT imaging alone. Included in this visit is a pre-operative physical examination (height, weight, abdominal examination), pre-operative blood examination (Hb, creatinin, eGFR) and patient questionnaires regarding patient knowledge, patient anxiety and patient quality of life.

DEVICE

Pre-operative surgical planning (CT only)

Online assessment by surgeon regarding clamping strategy. Assisted by classical CT imaging only.

PROCEDURE

RAPN (CT only)

Robot-assisted partial nephrectomy surgical procedure. Peri-operative guidance by CT imaging only.

Sponsors & Collaborators

• Stichting tegen Kanker

  collaborator OTHER

• University Ghent

  collaborator OTHER

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Charles Van Praet, MD, PhD · University Hospital, Ghent

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-27

Primary Completion

2027-01-01

Completion

2027-01-01

Countries

• Belgium

Study Locations