The Patient Pathway & Administration The Patient Pathway & Administration of CReSTof CReSTof CReSTof CReST

Laura MagillLaura MagillLaura MagillLaura MagillCReST Trial CoordinatorCReST Trial Coordinator

CReST is funded by CRUK and was developed by the NCRI Colorectal Cancer CSGCancer CSG

Participating CentresParticipating Centres

71 confirmed or interested CReST centres –

37 Northern centres

Eli ibilit C it iEligibility Criteria

Inclusion criteria:Radiologically proven colonic obstruction of left colon/upper rectum

presumed secondary to a carcinomapresumed secondary to a carcinomaFit for surgery

Exclusion Criteria:Signs of peritonitis and/or perforation Right iliac fossa tenderness & features of incipient caecal perforationObstruction in the rectum, that may require neoadjuvant therapy (i.e. tumours

in the mid or lower rectum)Unfit for surgical treatments or refuse surgical treatment.

Patient Pathway in CReSTPatient Pathway in CReST

Id tif i Eli ibl P ti tIdentifying Eligible Patients

Patients admitted acutely

Patient has FBC, U&E estimation and liver function tests

Patient has CT scan or contrast enema to confirm obstruction

Patient consent is obtained either from the e co se s ob ed e e o epatient or an appropriate consultee

Patient is randomised & put forward for relief of obstructionwithin 24 hours of admission

i CPatient Consent Process

Fully informed consent always sought, but not always possible in CReST

E t d l M t l H lth A t d EU Di tiEmergency consent procedures apply – Mental Health Act and EU Directive guidelines

Cascade system in place for patients unable to consent for themselves:Cascade system in place for patients unable to consent for themselves:- Informed assent from next of kin or equivalent- Doctor not connected with CReST

Each centre to identify doctor(s) for out-of-hours consent

If i f ti t th t bl t th t t ti l ti t ldIf no information to the contrary, reasonable to assume that a potential patient would wish to enter the trial.

Patient Consent & Randomisation

Randomisation by

i) Telephone 0800 953 0274i) Telephone – 0800 953 0274

ii) https://www.trials.bham.ac.uk/CReST

Once patient randomised BCTU send reminder e mail to either:reminder e-mail to either:

- CReST radiologist to request Colorectal Stent insertion Form

- CReST surgeon to request Colorectal Intraoperative Form

Sample GP letter –sent out after randomisation

Patient pathway after p yrandomisation

RObstructing Colorectal cancer

Emergency surgery

Insertion of endoluminal stent

Failed stenting

Palliative

Inclusion criteria e.g. diagnosis by CT scan or contrast enema

Successfuldecompression

Elective surgery

Palliative care

surgery

All patients relieved of obstruction within 24 hours of admissionAll patients relieved of obstruction within 24 hours of admission

Patient pathway after randomisation

Form completed either immediately for patients allocated emergency surgeryg y g y

Or, form completed at surgery ideally 1 -4 weeks after

d i i f i drandomisation for patients stented

Records surgical complications

Reminder e-mail to surgeon if form not received by BCTU within 30 days of surgery

Stent Insertion Form

Collects details of stent procedure

Captures any complications either during or immediately after the stenting procedure

Stent follow-Up form

Records early and lateRecords early and late complications

Stent failure is defined as failure to relieve obstruction within 48 hours

Karnofsky and WHO collected 48 hours post-stent and immediately prior to surgery

C P thCommon Pathway –Hospital Discharge Form

Post-operative complications recorded for all patients at 30-days post surgerydays post surgery

Form completed by research nurse at site

Research nurse sent reminder via e-mail that form due for completion

Common Pathway –F ll UFollow-Up

Follow-up at 6 months

Then annual FU for 3 years

If patient has had surgery? WasIf patient has had surgery? Was surgery curative?

FU form requests recurrence & death info, protocol deviations, events requiring hospitalisation

QoL assessed using EQ 5DQoL assessed using EQ 5D, EORTC QLQ-C29 and C30.

Serious Adverse EventsSerious Adverse Events

SAEs – fatal, life-threatening, require or prolong hospitalisation or are significantly or permanently disabling

For purposes of trial, adverse events include, but aren’t limited to:

- Failure to deploy the stent

- Bowel perforation

- Stent displacement

All SAEs reported to BCTU within 1 week

Serious Adverse Event Reporting

MUST be reported to BCTU within 1 week

Addn info may be requested from siteAdd info may be requested from site

Local PI to assign causality SAE before reporting

F h AE tFor each AE report:- full details with diagnosis, if possible- start and end dates, times

action taken- action taken- outcome- causality

BCTU to report SAEs to DMEC every 3 months, annual safety reports to MREC & TSCMREC & TSC

How to get involved

Complete the PAF

Send to BCTU at e.l.magill@bham.ac.uk or post

BCTU apply for LREC & R&D on behalf of site

Once approved – site file sent out, CRFs provided

BCTU will organise supply of stents to each siteBCTU will organise supply of stents to each site

All info on : www.bham.ac.uk/CReST

Contact detailsContact details

Laura MagillCReST Trial CoordinatorBirmingham Clinical Trials UnitDivision of Medical SciencesUniversity of BirminghamRobert Aitken InstituteEd b t

Tel: 0121 415 9105EdgbastonBirminghamB15 2TT

E-mail:e.l.magill@bham.ac.uk

bh k/CR STB15 2TT www.bham.ac.uk/CReST