3D Virtual Models as an Adjunct to Preoperative Surgical Planning

February 11, 2020 updated by: Dr Eoin R Hyde

Single-site Single-arm Feasibility Study of Patient-specific Interactive 3D Anatomical Models Aimed at Improving Surgery Planning Processes for Complex Renal Cancer Patients

This study aims to determine the feasibility of undertaking a future definitive RCT to evaluate the clinical effectiveness of complementing existing medical scans with a patient-specific interactive 3D virtual model of the patient's body to assist the surgeon with planning for the operation in the best way possible. Renal cancer patients receive a tri-phasic CT scan as routine practice, thus if the standard imaging protocols are followed, there should be ample imaging data available for 3D model creation.

This study is a single-site, single-arm, unblinded, prospective, feasibility study aiming to recruit 24 participants from the Royal Free Hospital that are scheduled for robotic-assisted partial nephrectomy. Consenting participants will be recruited over a 6-month period, and interactive 3D virtual models of their anatomy will be generated. These models will be used to aid surgeon-patient communications and to plan for the operation. This study will determine whether a definitive RCT of virtual 3D models as an adjunct to surgery planning is feasible with respect to: recruitment of local authorities and patients; ensuring staff can be adequately trained to deliver programmes within specified timeframes; and assessment of the measurability of key surgical outcomes.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Surgery is the mainstay treatment for abdominal cancer, resulting in over 50,000 surgeries annually in the UK, with 10% of those being for renal cancer. Preoperative surgery planning decisions are made by radiologists and surgeons upon viewing CT and MRI scans. The challenge is to mentally reconstruct the patient's 3D anatomy from these 2D image slices, including tumour location and its relationship to nearby structures such as critical vessels. This process is time consuming and difficult, often resulting in human error and suboptimal decision-making. It is even more important to have a good surgical plan when the operation is to be performed in a minimally-invasive fashion, as it is more challenging setting to rectify an unplanned complication than during open surgery. Therefore, better surgical planning tools are essential if one is to improve patient outcome and reduce the cost of surgical misadventure.

To overcome the limitations of current surgery planning in a soft-tissue oncology setting, dedicated software packages and service providers have provided the capability of classifying the scan voxels into their anatomical components in a process known as image segmentation (see Section 6.1 for more information). Once segmented, stereolithography files are generated which can be used to visualise the anatomy and have the components 3D printed. It has previously been shown that such 3D printed models influence surgical decision-making. However, the relevance of a physical model to plan for a minimally invasive surgical approach is debatable, and the financial and administrative costs of obtaining accurate 3D printed models for routine surgery planning has been speculated to be holding back 3D printed models from breaking into regular clinical usage.

As a necessary precursor to 3D printed models, computational 3D surface-rendered virtual models could be used by the urologist to assist with clinical decision-making. In the literature, such models are referred to by a variety of names such as '3D-rendered images', '3D reconstructions', or 'virtual 3D models'. In this protocol, the investigators will use the latter nomenclature. Virtual 3D models provide many of the advantages of their physical 3D printed counterpart without the challenge of the printing process, they can be easily viewed on standard digital devices such as laptops or smartphones and can be simultaneously viewed and interacted with from anywhere in the world, which could help with collaborative surgery planning between centres. Note that this study's use of virtual 3D models is not to be confused with Virtual-Reality visualisation, which is an immersive environment and currently requires specialist equipment. In support of this study, previous pioneering studies have already shown that surgeons benefit from computational 3D models in the theatre. However, in addition to the available 2D medical images (CT, MRI, volume-rendered images), it has not been shown that virtual 3D models, constructed from the same existing medical scan data, would influence the surgical decision-making process or alter surgeon confidence in their decisions. Crucially, it also remains to be shown that such 3D models can be built reliably and at scale to facilitate their widespread adoption.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study concerns patients that have been selected for minimally invasive renal cancer surgery at the Royal Free Hospital.

Description

Inclusion Criteria:

  1. Aged between 18 - 80 years, inclusive;
  2. Male and female;
  3. Diagnosed with T1a, or T1b renal tumours;
  4. Suitable for elective robot-assisted partial nephrectomy;
  5. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. aged <18 or >80 years;
  2. have had prior abdominal surgery;
  3. have had pre-operative imaging that is not adherent to the study protocol;
  4. contraindicated for biopsy;
  5. do not consent to have biopsy;
  6. have a body mass index (BMI) ≥35 kg/m^2;
  7. have a bleeding disorder;
  8. have baseline chronic kidney disease (CKD);
  9. not fit or do not consent for surgery;
  10. chose to have treatment outside the Royal Free Hospital;
  11. participation in other clinical studies that would potentially confound this study;
  12. unable to understand English;
  13. unable to provide consent themselves;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MIS-PN
Participants approved for elective robot-assisted partial nephrectomy with T1a or T1b renal tumours.

The study radiologist will generate a patient-specific virtual 3D model of the participant's body from their pre-operational medical scans (CT, and MRI if available) using regulated commercial medical image analysis software, specifically Osirix MD 9.0 (Pixmeo, Geneva, Switzerland).(Rosset et al. 2004)

The CRFw checks that the medical scan segmentation is accurate and validates the virtual 3D model.

The surgeon checks that the medical scan segmentation is accurate and validates the virtual 3D model.

The surgeon uses all available medical scan data, and the virtual 3D model as an adjunct, to assess the patient anatomy and plan the operation accordingly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study participant recruitment rate as assessed by number of participants divided by the total number of invited eligible patients.
Time Frame: 6 months

Determination of participant recruitment rates of eligible patients to this study.

Assessment: ratio of consenting patients to eligible patients

6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of study participants willing to be randomized.
Time Frame: 6 months
Determination of the willingness of eligible patients to be randomised (although this is a single-arm study and no randomisation will occur, this is an important outcome for future study design); Assessment: ratio of consenting patients that are favourable to randomisation to non-favourable
6 months
Time spent by surgeons in pre-operative planning.
Time Frame: 6 months

Determination of the time spent by surgeons in pre-operative planning using the 3D model building software.

Assessment: Recording of time spent planning

6 months
Practicality of delivering the patient-specific 3D model to the Operating Room.
Time Frame: 6 months

Determination of the practicality of delivering the patient-specific 3D model to the Operating Room visualisation device.

Assessment: Recording whether the 3D model was available for surgeon reference throughout the operation

6 months
Surveying patient opinion on the usefulness of 3D models.
Time Frame: 6 months

Determination of patient opinion on the usefulness of 3D models for improved understanding of the potential risks and benefits involved in their upcoming operation.

Assessment: The patient will be asked a single qualitative question to assess their opinion on the use of 3D models: "With regards to your understanding of the potential risks and benefits of your upcoming operation, do you feel that the additional use of 3D virtual models - decreased your understanding, made no difference to your understanding, or improved your understanding?"

6 months
Feasibility of measuring of peri-operative operation time.
Time Frame: 6 months

Measurability of peri-operative operation time from first incision to last suture.

Assessment: Ability to record the operation time in seconds.

6 months
Feasibility of measuring of peri-operative acute haemorrhage events.
Time Frame: 6 months

Measurability of peri-operative number of acute haemorrhage events.

Assessment: Ability to record the number of acute haemorrhage events.

6 months
Feasibility of measuring of peri-operative blood loss.
Time Frame: 6 months

Measurability of peri-operative blood loss.

Assessment: Ability to record the blood loss in millilitres.

6 months
Feasibility of measuring of peri-operative number of transfusion events.
Time Frame: 6 months

Measurability of peri-operative number of transfusion events.

Assessment: Ability to record the number of transfusion events.

6 months
Feasibility of measuring of post-operative number of haemorrhage events.
Time Frame: 6 months

Measurability of post-operative number of haemorrhage events.

Assessment: Ability to record the number of post-operative haemorrhage events (up to seven days post-operation).

6 months
Feasibility of measuring of post-operative participant length-of-stay in hosital.
Time Frame: 6 months

Measurability of post-operative participant length-of-stay in hosital.

Assessment: Ability to record the participant length-of-stay in hosital in days.

6 months
Feasibility of measuring of post-operative number of surgical site infection events.
Time Frame: 6 months

Measurability of post-operative number of surgical site infection events.

Assessment: Ability to record the number of surgical site infection events (up to seven days post-operation).

6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Faiz H Mumtaz, MBBS, MD, Royal Free Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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