Project Summary
INSITE MUO (INcidence of malignant ureteric obStruction In patienTs with non-organ confined abdominopElvic malignancy) is a multicentre retrospective study exploring the incidence and management of malignant ureteric obstruction.
Urologists and Interventional Radiologists are frequently referred cancer patients with hydronephrosis secondary to malignant ureteric obstruction (MUO). This causes renal failure, severe pain, urosepsis, and may prevent cancer treatment or threaten life. Percutaneous nephrostomy (PCN) insertion*, and ureteric stenting (US)** can relieve obstruction. Both require regular tube exchanges in hospital, usually for the patient's remaining lifetime.
Unlike other oncology emergencies such as metastatic spinal cord compression, no standardised care pathway exists for MUO and there is geographical variation in management approach. In addition, little is known about the MUO patients that do not receive intervention. The incidence of MUO is poorly captured, particularly across different advanced malignancies.
INSITE MUO seeks to retrospectively capture and analyse ALL patients with MUO irrespective of management option, and identify a population at risk using CT scan reports to determine the incidence of MUO in non-organ confined abdominopelvic malignancies.
Timeline:
<April 1st 2024 (Preparation phase)
Team setup, local project registration and local approvals (Caldicott)
Requests for data sent locally - "CT scans involving the abdomen and pelvis over two 2 week periods (31/10/2022 - 13/11/22 & 1/5/23 - 14/5/23 inclusive)". This is the time period data will be collected from.
1st April - July 2024 (Data collection phase)
Step 1: Excluding non-cancer cases.
Reports of CT scans from 31/10/2022 to 13/11/22 AND 1/5/23 to 14/5/23 are screened. Non-cancer cases excluded.
Step 2: Data collecting cancer cases but not MUO (population at risk)
Details of the remaining cases of cancer and not MUO (population at risk of MUO) entered into REDCap database (https://projectredcap.org). Local team links annonymised REDCap ID to locally kept patient identifier sheet.
Step 3: Data collecting MUO cases
MUO cases (approx <10) imaging review (post FRCR Radiology/Interventional Radiology SpR) and follow-up data entry into REDCap.
>July 2024 (Analysis & Dissemination)
Data analysis by INSITE MUO team at The University of Edinburgh.
Writing-up and dissemination.
Teams
To encourage equitable spread of workload, 1 collaborator will be allowed per 1000 CT reports screened (rounded up). As a guide, estimate 3700 scans per million of NHS Healthcare Trust catchment population.
Collaborators can be medical students or junior doctors of any specialty or grade.
One must be the lead collaborator who will lead the project locally including local project registration, any required Caldicott guardian/information governance local approvals, and liaison with the INSITE MUO central study team when required.
The name of the lead collaborator must be emailed to the INSITE MUO study team before data collection starts.
In addition to the data collection team there should be
A post FRCR Radiology or Interventional Radiology SpR (to do Step 3).
A supervising Consultant (who may be a Radiologist/Interventional Radiologist/Urologist/Both.
UNITE will provide certificates for all lead collaborators and collaborators.
Work Load Example
Pilot data suggests an NHS Trust with a catchment of 1 million people will result in approx 3700 CT reports
For a Trust of this size pilot data suggests:
Step 1 will take approximately 23.5 Hrs
Approximately 20% of scans will be eligible for step 2 (eg 740 in this example)
Step 2 will take approximately 92 Hrs (but will depend on local data collection setup and may range from 62-123Hrs)
Step 3 will be much quicker and only 1-10 MUO cases are expected per site. A post-FRCR radiology SpR will need to look at the MUO images for some of this data collection.
A team setup is therefore advised as above to enable work to be manageable
Authorship policy
Publication will be as a collaborative.
All collaborators will be accredited as collaborators on any publications from the study and will be Pubmed citable.
Getting involved
If you are interested in getting involved, please enter your details here: https://forms.gle/b6shT6VSRgZc38co8 or email MUOstudies@gmail.com for more information.
Ethics
The INSITE MUO protocol has been reviewed by the NHS research ethics committee in Edinburgh as is designated as service evaluation not requiring any further ethical approvals.
*Nephrostomy involves radiologically-guided insertion of a drain percutaneously into the obstructed kidney, under local anaesthetic. It’s often technically successful but frequently complicated by displacement, leaking, blockage and sepsis, long-term admission, and poor quality of life.
**Ureteric stenting involves a cystoscopically inserted stent, usually under general anaesthetic. Insertion fails more often, and patients experience irritation symptoms. Complications include haematuria, infection, blockage, and longer-term failure.
Investigators
Dr Oliver Llewellyn MRCS FRCR is an Interventional Radiology ST5 in Glasgow and RCR Kodak Research Fellow
Mr James Blackmur PhD FRCSEd(Urol) is a post-CCT Senior Clinical Fellow in Urology at Addenbrooke’s Hospital, Cambridge.
Mr Jonathan Aning FRCS(Urol) DM BM BS BMedSci is a Consultant Urologist at Bristol Urological Institute and Honorary Associate Professor at Bristol University
Dr Tristan Barrett FRCR MD is an Associate Professor of Radiology and Consultant Radiologist at Addenbrookes Hospital, Cambridge.
Mr Alexander Laird PhD FRCSEd(Urol) is a Consultant Urologist and Honorary Clinical Lecturer at The University of Edinburgh.
Study Documents:
Link to data request email
https://drive.google.com/file/d/1ObUhHhvg8NbfU2zjl7FbqIYyTQ3EtRco/view?usp=drive_link
Link to project instructions
https://drive.google.com/file/d/1PxWLBA-qBLF0Bep7zYp155R0AUYZ4jhU/view?usp=sharing
Link to project instructions appendix
https://drive.google.com/file/d/1pkwVajCEoAGdTm5QQUw4je9l4izcxffQ/view?usp=sharing