Background
Urologists and Interventional Radiologists are frequently referred 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. The incidence of MUO is poorly captured, particularly across different advanced malignancies, but may be approximately 4%. Study 1 (INSITE MUO) seeks to determine the incidence and investigate the management of MUO in non-organ confined abdominopelvic malignancies and learn about the MUO population not intervened on.
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.
Small studies show poor overall survival and stent-failure free survival in this cohort. Unfortunately, referrals are often an emergency, and the decisions required are taken by clinical teams unfamiliar with a patient’s particular situation.
In the largest MUO study to date, we retrospectively reviewed 905 Scottish MUO patients intervened on (6 hospitals), and developed the Scottish MUO Score for prognostication (https://webapps.igc.ed.ac.uk/world/research/muo_calculator/. This data also demonstrated considerable variation in practice and showed that only 57% of patients received further oncological treatment post-intervention.
Despite its size, our large retrospective dataset is unable to accurately capture why treatment decisions were made and if they were realised. This data requires prospective methods. To inform that aim, we demonstrated feasibility of scalable prospective data capture locally using the RedCap platform (64 patients, 10 months, NHS Lothian). Study 2 (OPTIMISE MUO) seeks to perform this across multiple sites to prospectively identify MUO cases presenting to hospital, record the rationale for MUO management choices, and identify if patient outcomes match the initial intended outcome.
------------------------------------------------------------------------------------------------------------------------------
INSITE MUO
(INcidence of malignant ureteric obStruction In patienTs with non-organ confined abdominopElvic malignancy)
Project website: https://www.unitecollaborative.com/projects/insite-muo
Starting April 2024
INSITE MUO is a retrospective audit and will assess the incidence within the ‘at risk’ population for MUO and to assess readmission and re-intervention rates dependent on treatment modality. Importantly the methodology of INSITE MUO will capture and enable learning about the population of MUO patients who are not initially intervened on.
Inclusion criteria:
- All CT scans of any CT protocol during the study period that involve the abdomen and pelvis
- Patients aged 18 and over
Exclusion criteria:
- Imaging modality other than CT
- Unreported CT examinations (number to be recorded by study teams)
Timeline:
<April 1st 2024 (Preparation period)
- Team setup, local project registration and local approvals
- 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)" See website.
1st April - July 2024 (Data collection period)
Step 1:
- Reports of CT scans screened. Non-cancer cases excluded.
Step 2:
- Remaining cancer case details entered into REDCap database (https://projectredcap.org). Local team links annonymised REDCap ID to locally kept patient identifier sheet.
Step 3:
- 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, a maximum of 1 collaborator will be allowed per 1000 CT reports (~6hrs work) screened (Estimate 3500 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 audit locally including local audit 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
UNITE will provide certificates for all lead collaborators and collaborators.
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.
Local teams will have the opportunity to present and re-audit their own data should they wish.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 - OPTIMISE MUO (prOsPecTIve MultIcentre Study investigating the managemEnt of patients with Malignant Ureteric Obstruction)
Starting August 2024
OPTIMISE MUO is a prospective audit and will prospectively assess the rationale for intervention. It will also assess if that rationale is ultimately realised, and whether there are differences in how mode of intervention impacts on this. We hypothesise that >50% of patients do not meet their specified aim for intervention.
Mandatory team members: Consultant Urologist, Consultant Radiologist, Urology Registrar or Core Trainee, Radiology Registrar. Additional team members such as medical students, FY1&2, or FY2+ are optional.
This study methodology is informed by our local prospective pilot study, supported by a BSIR Audit Bursary.
Inclusion criteria:
- Patients aged 18 years old and over
- Diagnosed with MUO as part of their standard clinical care
- Undergoing: Percutaneous nephrostomy insertion, ureteric stent insertion, no intervention, Other rare forms of intervention such as extra-anatomical stent insertion or urinary diversion
Exclusion criteria:
- Patients who have had previous intervention for MUO
- Patients where the ureteric obstruction is caused by non-malignant process, e.g. trauma, ureteric calculus, ureteric stricture, retroperitoneal fibrosis.
Methods
The OPTIMISE MUO methodology relies on a close working relationship between the study team and the local radiology and urology clinical teams (i.e case capture will be most effective if on call, inpatient, and outpatient reporting radiologists and on call urology teams know to flag MUO cases to the local OPTIMISE MUO study teams). It is for this reason that Consultant Radiologist and Urologist inclusion is mandatory in the local study team.
Identification of participants:
Local study leads will advertise the study to local Urology and Radiology Departments. Local radiologists will be asked to flag MUO cases to local study teams. Patients will also be identified from Urology and Interventional Radiology referrals for intervention. Diagnosis of MUO will be made as part of standard care. Patients will be identified over a 3-month study period and followed up at 3 month intervals for 9 months.
Data collection
The RedCap platform will be utilised for data collection. Local teams will assess the reason for intervention: treatment path chosen, reason for approach, admission type (elective or emergency), details of further disease treatment planned. Follow-up data will include survival, renal function and readmissions (including reason for admission, elective or emergency, any interval changes to intervention approach along with oncological treatment status). Patients will continue to follow standard care throughout. Data in REDCap will be anonymised and so local teams will be required to keep a legend linking patient serial numbers to their identifiers (NHS no).
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Where will the projects be lead from?
The projects will be coordinated from NHS Lothian and The University of Edinburgh. The UK National Interventional Radiology Trainee Research (UNITE) Collaborative and British Association of Urological Surgeons (BAUS) Oncology section study teams will communicate with the coordinating centre.
Project Team
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 (BUI) and Honorary Associate Professor at Bristol University
Mr Alexander Laird PhD FRCSEd(Urol) is a Consultant Urologist and Honorary Clinical Lecturer at The University of Edinburgh.
Timeline
INSITE MUO commencing April 2024
OPTIMISE MUO commencing August 2024
Contact us: MUOstudies@gmail.com
