RecruitingNot ApplicableNCT06536439

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool: a Randomized Controlled Trial Evaluating the DIPLANN 3D Model for Selective Arterial Clamping During Robot-Assisted Partial Nephrectomy

Sponsor

University Hospital, Ghent

Enrollment

235 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a digital planning tool called DIPLANN to help surgeons decide the best surgical strategy when removing kidney tumors using robotic surgery. It compares outcomes when surgeons use this digital tool versus relying on standard CT imaging alone. **You may be eligible if...** - You are 18 or older with a kidney tumor (stage T1-T2, no spread) - You are planned for robotic-assisted partial kidney removal (RAPN) - You have had a multiphase CT scan with an arterial phase available - You speak Dutch, English, or French **You may NOT be eligible if...** - You do not have the required CT imaging available - Your condition requires a different surgical approach than what the study specifies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPre-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.

DEVICEPre-operative surgical planning (DIPLANN + CT)

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

PROCEDURERAPN (DIPLANN + CT)

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

DEVICEPre-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.

DEVICEPre-operative surgical planning (CT only)

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

PROCEDURERAPN (CT only)

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