MRI in Normal Ileal Pouches, and a Feasibility Study of Dynamic MRI Enema and Defaecating MRI Pouchography

February 25, 2020 updated by: London North West Healthcare NHS Trust

Pelvic Collections on MRI in Patients With Ileal Pouches, and a Feasibility Study of Dynamic MRI Enema and Defaecating MRI Pouchography

A study to investigate the prevalence of pelvic collections in a representative sample of participants with normally functioning ileal pouches. It also aims to establish the feasibility and reporting variables for dynamic MRI enemas in ileal pouches and defaecating enema pouchography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ulcerative Colitis Ulcerative Colitis (UC) is the most common of the inflammatory bowel diseases, with approximately 146,000 sufferers in the UK (NICE, 2011). Unlike other inflammatory bowel diseases, the inflammation in UC affects only the large bowel, starting at the rectum and extending proximally (towards the mouth end of the gut). Three in four patients are managed with medical treatments with acceptable control of their disease, but patients may require surgical removal of their large bowel for several reasons. The one in four patients who have their colon removed (colectomy) either need an emergency operation for infection, perforation or bleeding, or a planned operation for failure of medical management, intolerance to medication, cancer or steroid dependence (1). Because the inflammation is confined only to the colon, this surgery is curative.

Having removed the large bowel, there are options with regard to what to do with the end of the remaining small bowel, the ileum. In 1978 Professor Sir Alan Parks and Professor John Nicholls publicised their operation for 'restorative proctocolectomy' (RPC) folding and suturing together loops of small bowel to create a 'pouch' to take over the reservoir function of the rectum, and giving the patient the chance of continence without the need for a stoma (2,3). This operation has become extremely popular over the last 38 years, and is considered internationally to be the gold standard for 'restorative proctocolectomy' in patients who choose not to have a permanent stoma (4).

The operation has been refined in the years since it's introduction (5), with roughly two thirds of patients enjoying acceptable function. However, the complications associated with creating an RPC; notably pelvic sepsis, fistulae, poor mechanical function and inflammation, mean that the cumulative rate of pouch failure is roughly 5% at five years, and up to 15% at 15 years (Ryoo et al. 2014; Remzi et al. 2015; Sherman et al. 2014; R. et al. 2012; Papadopoulos et al. 2010).

Pouch-Related Septic Complications St Mark's Hospital has one of the largest UK cohorts of patients with RPCs, and is a tertiary referral centre for pouch complications. Of the reasons for pouch failure, chronic pelvic sepsis is the major cause, at 50 to 60%. This is a long term infection in the pelvis around or near the pouch, causing inflammation and poor function.

The pouch itself may become inflamed, known as pouchitis, and the cause for this is unknown, but it is hypothesised that the inflammation is caused by a change in the type of bacteria present in the pouch as opposed to the small bowel when it was in normal continuity.

Generally speaking, the management of pelvic sepsis causing pouch function is to surgically or radiologically drain the pelvic collection, or eventually surgically remove the pouch. The management of pouchitis (primary idiopathic pouchitis) is primarily with antibiotics, but in prolonged cases where antibiotics have been ineffective it may be in the patient's benefit to treat the inflammation with steroids or 'biologic' medications. These medications act by suppressing the body's innate immune response, and it would be inappropriate to use these medications if the true cause of inflammation is ongoing sepsis in the pelvis because this infection would likely become significantly worse, causing systemic infection (sepsis).

Unpublished research from St Mark's completed at the end of 2015 http://scripties.umcg.eldoc.ub.rug.nl/root/geneeskunde/2016/PloegVvander/ showed that in 68 patients treated for primary idiopathic pouchitis, 38% had an incidental pre-sacral collection identified on MRI, potentially consistent with pelvic sepsis driving the inflammation, rather than the inflammation rising primarily from the pouch itself.

Five patients went on to have drainage of the pelvic sepsis, with resolution of symptoms in only one. Therefore, based on this series, the significance of a pre-sacral collection on MRI in the context of pouchitis is unknown. Beyond this, it is not known how often this finding may be present as a 'normal variant' in patients with normal functioning pouches. The proposed trial would help to guide clinical management of patients with pouchitis and pre-sacral collections.

Pouch Evacuatory Dysfunction

A different type of problem with ileal pouches is the inability to easily evacuate the pouch. The majority of patients with normally functioning pouches, pressure to open their bowels is felt just like people with normal anatomy. Some patients have difficulty evacuating the pouch, often without an obvious inflammatory or anatomical cause. These patients are often investigated with defaecating pouchography, which is an investigation using moving x-ray images of radio-opaque contrast material being evacuated by the patient. A study conducted at St Mark's and published in August 2016 (11) demonstrated that this investigation has a relatively poor diagnostic value, partly due to the fact that there is no established range of normal findings. Using moving MRI images in patients with normal anatomy (called MRI defaecating proctography) is replacing the use of x-ray moving images (fluoroscopy) as there is as much, if not greater detail on the images, and there is no radiation exposure for the patient.

This study would be a pilot trial of the use of defaecating MRI in patients with pouches, (defaecating MRI pouchography) to establish whether the technique translates to patients with pouches instead of a rectum, and to establish what the range of normal findings are before going on to utilise the technique in patients with evacuatory dysfunction. This technique has not yet been described in the medical literature.

Study Type

Observational

Enrollment (Actual)

19

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

  • United Kingdom
    • Middlesex
      • London, Middlesex, United Kingdom, HA1 3UJ
        • St Mark's Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ulcerative colitis who have had an ileal pouch formed and never had any septic or inflammatory complications, at least three years from reversal of ileostomy.

Description

Inclusion Criteria:

  • • Ileal pouch reservoir in situ

    • Greater than three years since closure of ileostomy
    • Normal pouch function as defined by Orësland score of <4
    • Never had a diagnosis of pouchitis
    • Never had treatment for pouchitis
    • No evidence of pouchitis on rigid pouchoscopy
    • CRP <10

Exclusion Criteria:

  • • Contraindications to magnetic resonance imaging (MRI) See appendix 1.

    • Unable or unwilling to agree to informed consent
    • Known inability to tolerate MRI (e.g. impaired mobility or claustrophobia)
    • Known gadolinium allergy
    • Known inability to maintain anal continence

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
Patients with normal ileal pouches

Inclusion Criteria

  • Ileal pouch reservoir in situ
  • Greater than three years since closure of ileostomy
  • Normal pouch function as defined by Orësland score of <4
  • Never had a diagnosis of pouchitis
  • Never had treatment for pouchitis
  • No evidence of pouchitis on rigid pouchoscopy
  • CRP <10
Other: MRI with ileal pouch contrast and enema.
Pre enema 20mg IV or IM Hyoscine Butylbromide (Buscopan) Pre enema Small Field of View (SFOV) T2 sagittal series Pre enema SFOV T2 axial series Pre enema SFOV T1 sagittal series (fat suppressed) Pre enema SFOV T1 axial series (fat suppressed) Enema infiltration started During enema filling Dynamic T1 sagittal single image, fat suppressed, aligned on pouch-anal anastomosis During enema filling T1 sagittal series (fat suppressed) During enema filling T1 axial series (fat suppressed) Jelly infiltrated and held Evacuating series Oblique sagittal T2 evacuating series of the mid and distal pouch, aligned to the pouch-anal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prevalence of pelvic collections in a representative sample of patients with normally functioning ileal pouches.
Time Frame: Baseline ( MRI scan)
Baseline ( MRI scan)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A descriptive assessment of the normal variation of ileal pouches on MRI scans.
Time Frame: Baseline ( MRI scan)
Baseline ( MRI scan)
Assess the patient experience of MRI pouchography using enemas
Time Frame: Baseline ( MRI scan)
Non-validated questionnaire assessment of patient anxiety, comfort, embarrassment and confidence in the outcome.
Baseline ( MRI scan)

Collaborators and Investigators

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

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Guy HT Worley, BMBS MRCS, St. Mark's Hospital
  • Study Chair: Susan K Clark, PhD, St. Mark's Hospital

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 10, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mripouchesv1.11808216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Any data published will be fully anonymised. Identifiable patient data will be shared between the two sites conducting the research, this will be via secure email server. This arrangement is subject to UK Research and Ethics Committee scrutiny.

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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