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RECRUITING
NCT06536439
NA

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

235

Start Date

2024-06-27

Completion Date

2027-01-01

Last Updated

2025-04-01

Healthy Volunteers

No

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.

Locations (5)

AZORG

Aalst, Belgium

AZ Sint-Jan

Bruges, Belgium

ZOL

Genk, Belgium

AZ Maria Middelares

Ghent, Belgium

Ghent University Hospital

Ghent, Belgium