Image overlay for robot-assisted partial nephrectomy - a pilot study
| ISRCTN | ISRCTN16647364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16647364 |
| IRAS number | 225688 |
| Secondary identifying numbers | CPMS 35235, IRAS 225688 |
- Submission date
- 15/12/2020
- Registration date
- 03/02/2021
- Last edited
- 23/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Researchers are developing ways to improve robotic partial nephrectomies (removal of part of the kidney through keyhole surgery with the help of a robot controlled by the surgeon). One method would be to provide additional information to the surgeon by projecting the images from CT scans or MRI scans over the video images obtained during robotic surgery. This is not performed routinely at present because the pre-operative images cannot be accurately projected upon the video images obtained during the robotic surgery. The accuracy of the projection is affected by breathing motion, the pushing and pulling of the organs by the surgeon and due to the gas used during robotic surgery. The aim of this study is to investigate whether the use of computerised algorithms can calculate the position and change of shape required to accurately match the pre-operative CT or MRI scans to the live video images obtained during robotic surgery.
Who can participate?
Patients over the age of 18, diagnosed with a small renal mass requiring robot-assisted laparoscopic partial nephrectomy
What does the study involve?
The routine treatment plan will not change. However, the research would involve the following:
1. Video images from the laparoscope (available to the surgeon to perform the operation) will be recorded, anonymised and stored for later analysis.
2. The tracking information of the position of the various moving parts of the robot will be recorded.
3. Any pre-operative scans (MRI or CT) scans that have been undertaken will be overlaid on the video image. These images will be deformed using a computerised algorithm to account for the various deformation forces such as movement from breathing or pushing/pulling of organs by the surgeon.
4. There will be 1-2 additional personnel in the operating theatre to transfer the anonymised tracking and video image data from the Da Vinci Robot console.
Apart from recording the video images, using pre-operative scans and projecting them on the video screen, there will be no alteration in the care either during the time of recording or after completion of the operation.
What are the possible benefits and risks of participating?
The researchers do not anticipate any benefits to participants. If the research is successful, patients with a similar condition will benefit significantly because of the more detailed information that will be available to the operating surgeon.
The researchers do not anticipate any disadvantage or risks from taking part in this research. However, the true accuracy of the system in kidney surgery is not known since this system has only been used in people undergoing liver surgery previously. The accuracy of the system in people who undergo liver surgery was about 10 to 15 mm on average. The researchers anticipate better accuracy in kidneys since the kidney is more solid and less deformable than the liver. As there will be no interference with the video image that the surgeon will be using, The researchers do not anticipate any side effects of taking part.
Where is the study run from?
Royal Free Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2017 to September 2025
Who is funding the study?
University College London (UK)
Who is the main contact?
Eddie Edwards
eddie.edwards@ucl.ac.uk
Contact information
Scientific
University College London
Department of Surgery and Interventional Science
9th Floor, UCL
Royal Free Hospital
Pond Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)207 7942535 |
|---|---|
| m.tran@ucl.ac.uk |
Study information
| Study design | Observational validation of investigation/therapeutic procedures |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Image guidance with image overlay for robot-assisted partial nephrectomy - a pilot study |
| Study hypothesis | Pre-operative scan images can be used within a computerised algorithm to overlay pre-operative CT/MRI image onto intra-operative video images. |
| Ethics approval(s) | Approved 07/06/2017, North East – Newcastle and North Tyneside (Room 001, Jarrow Business Centre, Rolling Mill Road, Jarrow, Tyne & Wear, NE32 3DT, UK; +44 (0)207 104 8282; nrescommittee.northeast-newcastleandnorthtyneside2@nhs.net), REC ref: 17/NE/0182 |
| Condition | Specialty: Cancer, Primary sub-specialty: Renal Cancer; Health Category: Cancer and neoplasms; Disease/Condition: Malignant neoplasms of urinary tract |
| Intervention | The patient will be provided with an information sheet about the research. If the patient consents to being involved in the research, then they will be asked to sign the consent form, which allows the use of their pre-operative scan images, intra-operative video recording and also the retrieval of the tracking information of the instruments following the operation from the Da Vinci Robot. There will be no interference or change to the patients' usual clinical care. All data will be anonymised. The researchers will use a similar computerised algorithm that they have developed and used to overlay pre-operative images on live laparoscopic video images in patients undergoing diagnostic laparoscopy and laparoscopic liver resections. In this study they will overlay the pre-operative scan images onto the recorded intra-operative video images, and evaluate the error in the overlay (i.e. how far is the superimposed image from the live video image). |
| Intervention type | Other |
| Primary outcome measure | The accuracy of the overlay of pre-operative CT or MRI images onto live intra-operative laparoscopic images during robot-assisted laparoscopic partial nephrectomy; measured in mm as the distance between the aligned CT model and corresponding features in the endoscope view during the standard of care planned interventional surgery |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 07/06/2017 |
| Overall study end date | 15/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Participant inclusion criteria | 1. Age >18 years 2. Diagnosed with small renal mass requiring robot assisted laparoscopic partial nephrectomy 3. Willing and able to provide written informed consent. |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 18/10/2019 |
| Recruitment end date | 15/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pond Street
London
NW3 2QG
United Kingdom
Sponsor information
University/education
c/o Ms Misha Ladva
JRO UCL, Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)2034475557 |
|---|---|
| randd@uclh.nhs.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/04/2025: The following changes were made:
1. The overall study end date was changed from 31/03/2024 to 15/09/2025.
2. The intention to publish date was changed from 31/03/2025 to 31/12/2025.
3. The target number of participants was changed from "Planned Sample Size: 20; UK Sample Size: 20".
4. The recruitment end date was changed from 18/10/2022 to 15/09/2025.
15/12/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
