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

Kidney Tumor Clinical Trial

— 3DPN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056505
• Other study ID #: 3DPN
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2023
• Source: University of Leipzig
• Contact: Sigrun Holze, Dr.
• Phone: 0049 341 9717600
• Email: sigrun.holze[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: September 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Kidney Tumor

Intervention

Procedure:
• partial kidney nephrectomy
surgery for partial nephrectomy

Device:
• DaVinci Robot
device to perform the surgery for partial nephrectomy (not the intervention of interest)
• Innersight 3D software
investigational product to generate the 3D model

Locations

Country	Name	City	State
Germany	Sana Klinikum Borna, Klinik für Urologie	Borna
Germany	Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie	Dresden	Saxonia
Germany	St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie	Gronau
Germany	Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg
Germany	Leipzig University, Department of Urology	Leipzig	Saxonia
Germany	Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie	Magdeburg
Germany	Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie	Mainz
Germany	Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Safety endpoints - Number of operation- or kidney-related readmissions	Number of operation- or kidney-related readmissions	Visit 4: six months after operation
Other	Safety endpoints - Number of AEs, SAEs	Number of AEs, SAEs	Visit 4: six months after operation
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Peri-operative - Hilar clamping technique	Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)	Visit 2: during operation
Secondary	Peri-operative - Warm ischaemia time (WIT)	Warm ischaemia time (WIT) in minutes	Visit 2: during operation
Secondary	Peri-operative - Estimated blood loss	Estimated blood loss in ml	Visit 2: during operation
Secondary	Peri-operative - Number of transfusions	Number of transfusions	Visit 2: during operation
Secondary	Peri-operative - Total Operative time	Total Operative time measured from incision to suture in minutes	Visit 2: during operation
Secondary	Peri-operative - Number of conversions to open surgery	Number of conversions to open surgery	Visit 2: during operation
Secondary	Peri-operative - Number of conversions to radical nephrectomy	Number of conversions to radical nephrectomy	Visit 2: during operation
Secondary	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
Secondary	Post-operative - Positive margin status	Positive margin status, range: R0, R1, R2, RX	Visit 3: after operation up to 6 weeks
Secondary	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
Secondary	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
Secondary	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)