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Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

ConditionsKidney CancerKidney NeoplasmsKidney DiseasesRenal CancerRenal Cell CarcinomaRenal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

aged 18 years or above

cT1-2 N0 M0 renal mass

planned to undergo RAPN

multiphase CT scan with arterial phase available

Disqualifiers

> 3 ipsilateral renal masses

women who are pregnant or breastfeeding

previous renal surgery that is expected to complicate renal cancer surgery

cT ≥ 3

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

  • Pre-operative surgical planning (DIPLANN + CT)

    Device

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

  • RAPN (DIPLANN + CT)

    Procedure/Surgery

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

  • Pre-operative explanation of the procedure (CT only)

    Device

    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.

  • Pre-operative surgical planning (CT only)

    Device

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

  • RAPN (CT only)

    Procedure/Surgery

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

Treatment groups

235 Participants
are divided into 2 treatment groups
Group A: DIPLANN-tool + conventional CT imagingExperimental treatment 3 interventions
Group B: Conventional CT imaging aloneActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Selective clamping

Planning and performing as planned a selective clamping (SC) strategy (considered by the surgeon at the end of surgery, objectified pre- and postoperatively through online assessment on study website and controlled through video-analysis): planning SC and performing the planned SC strategy = positive outcome; planning SC and performing another SC strategy or full clamping (FC) = negative outcome; planning FC = negative outcome.

Time frame
During surgery

Secondary outcomes

1

eGFR 6 months

Change in eGFR at 6 months after surgery compared to eGFR preoperatively.

Time frame
6 months postoperatively
2

Clamping strategy

Clamping strategy performed (selective clamping or full clamping).

Time frame
During surgery
3

Hilar dissection time

Time to dissect hilum (minutes) as analyzed on postoperative surgical video analysis.

Time frame
During surgery
4

Conversion to full clamp

Conversion from SC to FC.

Time frame
During surgery

Other outcomes

1

Complications

Intra-operative and 90-day postoperative complications.

Time frame
90 days postoperatively
2

Estimated blood loss

Estimated blood loss during surgery (mL).

Time frame
During surgery
3

Perfusion model validation

Concordance between 3D perfusion model and peroperative kidney surface perfusion as visualized by ICG as estimated by postoperative surgical video analysis.

Time frame
During surgery
4

Low eGFR 6 months

eGFR (CKD-EPI) \<45 ml/min at 6 months after surgery.

Time frame
6 months postoperatively

Sponsors and contacts

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

University Hospital, Ghent

Lead sponsor

Stichting tegen Kanker

Collaborator

University Ghent

Collaborator

Source ClinicalTrials.gov
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