Back to resultsVirtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy (3DPN)
Primary Purpose
Kidney Tumor
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
partial kidney nephrectomy
DaVinci Robot
Innersight 3D software
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Tumor focused on measuring DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Partial kidney nephrectomy with aid of 3D model
Partial kidney nephrectomy with aid of 2D model
Arm Description
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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"
Pre-operative - STOA
STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"
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"
Pre-operative - NRS
numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)
Pre-operative - Patient satisfaction questionnaire
Patient satisfaction questionnaire regarding the informed consent process
Peri-operative - Hilar clamping technique
Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)
Peri-operative - Warm ischaemia time (WIT)
Warm ischaemia time (WIT) in minutes
Peri-operative - Estimated blood loss
Estimated blood loss in ml
Peri-operative - Number of transfusions
Number of transfusions
Peri-operative - Total Operative time
Total Operative time measured from incision to suture in minutes
Peri-operative - Number of conversions to open surgery
Number of conversions to open surgery
Peri-operative - Number of conversions to radical nephrectomy
Number of conversions to radical nephrectomy
Peri-operative - Surgeon confidence level
Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"
Post-operative - Positive margin status
Positive margin status, range: R0, R1, R2, RX
Post-operative - Creatinine
Creatinine in µmol/l
Post-operative - eGFR
eGFR (CKD-EPI) in ml/min/1,73m²
Post-operative - Patient length of stay
Patient length of stay in days
Full Information
NCT ID
NCT06056505
First Posted
June 16, 2023
Last Updated
September 29, 2023
Sponsor
University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT06056505
Brief Title
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Acronym
3DPN
Official Title
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Tumor
Keywords
DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment randomization to 3D or 2D modelling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial kidney nephrectomy with aid of 3D model
Arm Type
Experimental
Arm Description
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
Arm Title
Partial kidney nephrectomy with aid of 2D model
Arm Type
Active Comparator
Arm Description
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.
Intervention Type
Procedure
Intervention Name(s)
partial kidney nephrectomy
Intervention Description
surgery for partial nephrectomy
Intervention Type
Device
Intervention Name(s)
DaVinci Robot
Intervention Description
device to perform the surgery for partial nephrectomy (not the intervention of interest)
Intervention Type
Device
Intervention Name(s)
Innersight 3D software
Intervention Description
investigational product to generate the 3D model
Primary Outcome Measure Information:
Title
Primary endpoint is the console operation time measured intra-op.
Description
Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
Pre-operative - PRA-D
Description
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"
Time Frame
Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Title
Pre-operative - STOA
Description
STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"
Time Frame
Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Title
Pre-operative - APAIS
Description
Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree"
Time Frame
Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Title
Pre-operative - NRS
Description
numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)
Time Frame
Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Title
Pre-operative - Patient satisfaction questionnaire
Description
Patient satisfaction questionnaire regarding the informed consent process
Time Frame
Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Title
Peri-operative - Hilar clamping technique
Description
Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)
Time Frame
Visit 2: during operation
Title
Peri-operative - Warm ischaemia time (WIT)
Description
Warm ischaemia time (WIT) in minutes
Time Frame
Visit 2: during operation
Title
Peri-operative - Estimated blood loss
Description
Estimated blood loss in ml
Time Frame
Visit 2: during operation
Title
Peri-operative - Number of transfusions
Description
Number of transfusions
Time Frame
Visit 2: during operation
Title
Peri-operative - Total Operative time
Description
Total Operative time measured from incision to suture in minutes
Time Frame
Visit 2: during operation
Title
Peri-operative - Number of conversions to open surgery
Description
Number of conversions to open surgery
Time Frame
Visit 2: during operation
Title
Peri-operative - Number of conversions to radical nephrectomy
Description
Number of conversions to radical nephrectomy
Time Frame
Visit 2: during operation
Title
Peri-operative - Surgeon confidence level
Description
Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"
Time Frame
Visit 2: during operation
Title
Post-operative - Positive margin status
Description
Positive margin status, range: R0, R1, R2, RX
Time Frame
Visit 3: after operation up to 6 weeks
Title
Post-operative - Creatinine
Description
Creatinine in µmol/l
Time Frame
from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Title
Post-operative - eGFR
Description
eGFR (CKD-EPI) in ml/min/1,73m²
Time Frame
from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Title
Post-operative - Patient length of stay
Description
Patient length of stay in days
Time Frame
from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)
Other Pre-specified Outcome Measures:
Title
Safety endpoints - Post-op complications
Description
Post-op complications categorized by Clavien-Dindo classification (grad 1 to 5)
Time Frame
from the end of the operation until the day of discharge (up to 6 days)
Title
Safety endpoints - Number of operation- or kidney-related readmissions
Description
Number of operation- or kidney-related readmissions
Time Frame
Visit 4: six months after operation
Title
Safety endpoints - Number of AEs, SAEs
Description
Number of AEs, SAEs
Time Frame
Visit 4: six months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigrun Holze, Dr.
Phone
0049 341 9717600
Email
sigrun.holze@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Köppe-Bauernfeind
Phone
0049 341 97 16266
Email
nicole.koeppe-bauernfeind@zks.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Uwe Stolzenburg, Prof.
Organizational Affiliation
Leipzig University, Department of Urology
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
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