Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy (3DPN)

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

Study Overview

• Status: Recruiting
• Conditions: Kidney Tumor
• Intervention / Treatment: Procedure: partial kidney nephrectomy; Device: DaVinci Robot; Device: Innersight 3D software

Detailed Description

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

• Study Type: Interventional
• Enrollment (Estimated): 370
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigrun Holze, Dr.; Phone Number: 0049 341 9717600; Email: sigrun.holze@medizin.uni-leipzig.de
• Study Contact Backup: Name: Nicole Köppe-Bauernfeind; Phone Number: 0049 341 97 16266; Email: nicole.koeppe-bauernfeind@zks.uni-leipzig.de

Study Locations

• Germany
  • Borna, Germany, 04552
    • Not yet recruiting
    • Sana Klinikum Borna, Klinik für Urologie
    • Contact: Hoang Minh Do, PD Dr.; Email: Minh@Sana.de
  • Gronau, Germany, 48599
    • Recruiting
    • St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie
    • Contact: Matthias Oelke, Prof.; Email: matthias.oelke@st-antonius-gronau.de
  • Homburg, Germany, 66421
    • Recruiting
    • Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie
    • Contact: Stefan Siemer, Prof.; Email: stefan.Siemer@uks.eu
  • Magdeburg, Germany, 39120
    • Not yet recruiting
    • Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
    • Contact: Martin Schostak, Prof.; Email: martin.schostak@med.ovgu.de
  • Mainz, Germany, 55131
    • Not yet recruiting
    • Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie
    • Contact: Axel Haferkamp, Prof.; Email: axel.haferkamp@unimedizin-mainz.de
  • Mannheim, Germany, 68167
    • Not yet recruiting
    • Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
    • Contact: Karl-Friedrich Kowalewski, PD Dr.; Email: karl-friedrich.kowalewski@umm.de
  • Saxonia
    • Dresden, Saxonia, Germany, 01307
      • Recruiting
      • Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie
      • Contact: Christian Thomas, Prof.; Email: Christian.Thomas@ukdd.de
    • Leipzig, Saxonia, Germany, 4103
      • Recruiting
      • Leipzig University, Department of Urology
      • Contact: Jens-Uwe Stolzenburg, Prof.; Phone Number: +49 341 9717600; Email: jens-uwe.stolzenburg@uniklinik-leipzig.de
      • Contact: Sigrun Holze, Dr.; Phone Number: +49 341 9717600; Email: sigrun.holze@uniklinik-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
• CT scan with contrast medium available
• Age ≥ 18 years
• Written informed consent

Exclusion Criteria:

• History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
• Horseshoe kidney
• Previous malignancy with ongoing or planned nephrotoxic chemotherapy
• Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
• Tumor thrombus in Vena renalis or Vena cava inferior
• Existing renal insufficiency GFR < 15 ml/min/1.73m2
• Severe cognitive impairment
• Pregnancy or lactation or women with desire for children
• Patients under legal supervision or guardianship
• Unable to give informed consent or suspected lack of compliance
• Patients who refuse to data collection and storage for the main study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial kidney nephrectomy with aid of 3D model; The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.	Procedure: partial kidney nephrectomy; surgery for partial nephrectomy; Device: DaVinci Robot; device to perform the surgery for partial nephrectomy (not the intervention of interest); Device: Innersight 3D software; investigational product to generate the 3D model
Active Comparator: Partial kidney nephrectomy with aid of 2D model; The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.	Procedure: partial kidney nephrectomy; surgery for partial nephrectomy; Device: DaVinci Robot; device to perform the surgery for partial nephrectomy (not the intervention of interest)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint is the console operation time measured intra-op.	Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.	intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative - PRA-D	Quality of the Physician-Patient Relationship - Evaluation of the German Version of the Patient Reactions Assessment (PRA-D); fifteen items with seven expressions from "I do not agree at all" to "I agree completely"	Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - STOA	STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"	Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - APAIS	Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree"	Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - NRS	numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)	Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - Patient satisfaction questionnaire	Patient satisfaction questionnaire regarding the informed consent process	Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Peri-operative - Hilar clamping technique	Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)	Visit 2: during operation
Peri-operative - Warm ischaemia time (WIT)	Warm ischaemia time (WIT) in minutes	Visit 2: during operation
Peri-operative - Estimated blood loss	Estimated blood loss in ml	Visit 2: during operation
Peri-operative - Number of transfusions	Number of transfusions	Visit 2: during operation
Peri-operative - Total Operative time	Total Operative time measured from incision to suture in minutes	Visit 2: during operation
Peri-operative - Number of conversions to open surgery	Number of conversions to open surgery	Visit 2: during operation
Peri-operative - Number of conversions to radical nephrectomy	Number of conversions to radical nephrectomy	Visit 2: during operation
Peri-operative - Surgeon confidence level	Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"	Visit 2: during operation
Post-operative - Positive margin status	Positive margin status, range: R0, R1, R2, RX	Visit 3: after operation up to 6 weeks
Post-operative - Creatinine	Creatinine in µmol/l	from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - eGFR	eGFR (CKD-EPI) in ml/min/1,73m²	from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - Patient length of stay	Patient length of stay in days	from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints - Post-op complications	Post-op complications categorized by Clavien-Dindo classification (grad 1 to 5)	from the end of the operation until the day of discharge (up to 6 days)
Safety endpoints - Number of operation- or kidney-related readmissions	Number of operation- or kidney-related readmissions	Visit 4: six months after operation
Safety endpoints - Number of AEs, SAEs	Number of AEs, SAEs	Visit 4: six months after operation

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Study Chair: Jens-Uwe Stolzenburg, Prof., Leipzig University, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: DaVinci Surgical System; robotic-assisted partial nephrectomy; Kidney tumours
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: 3DPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the 3DPN trial will be made available to the scientific community.
• IPD Sharing Time Frame: After publication of the major results

IPD Sharing Access Criteria

After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification.

This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the metaanalysis.

Summary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the trial protocol in full will be made publicly available as well as the statistical analysis plan.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No