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Colitis, UlcerativeNCT02925260

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

An observational study of Colitis, Ulcerative and Ileal Pouches, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative, Ileal Pouches
What is being tested?
MRI with ileal pouch contrast and enema.
Type of treatment
Injection or infusion
How many people
19 participants
Where
1 siteUnited Kingdom
Study dates
10 May 2017to 1 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Mark's Hospital

    London, Middlesex, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
MRI with ileal pouch contrast and enema.
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI with ileal pouch contrast and enema.Other

    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

Study groups in NCT02925260
Study groupRoleWhat they receive
Patients with normal ileal pouchesInclusion 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
Receives: Other: MRI with ileal pouch contrast and enema.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of pelvic collections in a representative sample of patients with normally functioning ileal pouches.

    Measured: Baseline ( MRI scan)

Secondary outcomes (2)
  1. A descriptive assessment of the normal variation of ileal pouches on MRI scans.

    Measured: Baseline ( MRI scan)

  2. Assess the patient experience of MRI pouchography using enemas

    Non-validated questionnaire assessment of patient anxiety, comfort, embarrassment and confidence in the outcome.

    Measured: Baseline ( MRI scan)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start10 May 2017
  3. Primary completion1 Apr 2019
  4. Study completion1 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925260
Sponsor's protocol ID
mripouchesv1.11808216
Status last verified
Feb 2020
First submitted
3 Oct 2016
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

Publications

  • Myrelid P, Oresland T. A reappraisal of the ileo-rectal anastomosis in ulcerative colitis. J Crohns Colitis. 2015 Jun;9(6):433-8. doi: 10.1093/ecco-jcc/jjv060. Epub 2015 Apr 11.

    PubMed 25863275
  • Oresland T, Bemelman WA, Sampietro GM, Spinelli A, Windsor A, Ferrante M, Marteau P, Zmora O, Kotze PG, Espin-Basany E, Tiret E, Sica G, Panis Y, Faerden AE, Biancone L, Angriman I, Serclova Z, de Buck van Overstraeten A, Gionchetti P, Stassen L, Warusavitarne J, Adamina M, Dignass A, Eliakim R, Magro F, D'Hoore A; European Crohn's and Colitis Organisation (ECCO). European evidence based consensus on surgery for ulcerative colitis. J Crohns Colitis. 2015 Jan;9(1):4-25. doi: 10.1016/j.crohns.2014.08.012. No abstract available.

    PubMed 25304060
  • NICE Centre for Clinical Practice. Ulcerative colitis: the management of ulcerative colitis. 2011;(June):1-68.

  • Parks AG, Nicholls RJ. Proctocolectomy without ileostomy for ulcerative colitis. Br Med J. 1978 Jul 8;2(6130):85-8. doi: 10.1136/bmj.2.6130.85.

    PubMed 667572
  • Parks AG, Nicholls RJ, Belliveau P. Proctocolectomy with ileal reservoir and anal anastomosis. Br J Surg. 1980 Aug;67(8):533-8. doi: 10.1002/bjs.1800670802.

    PubMed 7427044
  • McLaughlin SD, Clark SK, Tekkis PP, Ciclitira PJ, Nicholls RJ. Review article: restorative proctocolectomy, indications, management of complications and follow-up--a guide for gastroenterologists. Aliment Pharmacol Ther. 2008 May;27(10):895-909. doi: 10.1111/j.1365-2036.2008.03643.x. Epub 2008 Feb 9.

    PubMed 18266993
  • Bach SP, Mortensen NJ. Revolution and evolution: 30 years of ileoanal pouch surgery. Inflamm Bowel Dis. 2006 Feb;12(2):131-45. doi: 10.1097/01.MIB.0000197547.80558.59.

    PubMed 16432378
  • Ryoo SB, Oh HK, Han EC, Ha HK, Moon SH, Choe EK, Park KJ. Complications after ileal pouch-anal anastomosis in Korean patients with ulcerative colitis. World J Gastroenterol. 2014 Jun 21;20(23):7488-96. doi: 10.3748/wjg.v20.i23.7488.

    PubMed 24966620
  • Remzi FH, Aytac E, Ashburn J, Gu J, Hull TL, Dietz DW, Stocchi L, Church JM, Shen B. Transabdominal Redo Ileal Pouch Surgery for Failed Restorative Proctocolectomy: Lessons Learned Over 500 Patients. Ann Surg. 2015 Oct;262(4):675-82. doi: 10.1097/SLA.0000000000001386.

    PubMed 26366548
  • Sherman J, Greenstein AJ, Greenstein AJ. Ileal j pouch complications and surgical solutions: a review. Inflamm Bowel Dis. 2014 Sep;20(9):1678-85. doi: 10.1097/MIB.0000000000000086.

    PubMed 24983986
  • Mennigen R, Senninger N, Bruewer M, Rijcken E. Pouch function and quality of life after successful management of pouch-related septic complications in patients with ulcerative colitis. Langenbecks Arch Surg. 2012 Jan;397(1):37-44. doi: 10.1007/s00423-011-0802-y. Epub 2011 May 19.

    PubMed 21594657
  • Papadopoulos VN, Michalopoulos A, Apostolidis S. Ileal pouch dysfunction. Tech Coloproctol. 2010 Nov;14 Suppl 1:S83-5. doi: 10.1007/s10151-010-0630-z.

    PubMed 20725759
  • Lovegrove RE, Tilney HS, Remzi FH, Nicholls RJ, Fazio VW, Tekkis PP. To divert or not to divert: A retrospective analysis of variables that influence ileostomy omission in ileal pouch surgery. Arch Surg. 2011 Jan;146(1):82-8. doi: 10.1001/archsurg.2010.304.

    PubMed 21242450
  • Sugerman HJ, Sugerman EL, Meador JG, Newsome HH Jr, Kellum JM Jr, DeMaria EJ. Ileal pouch anal anastomosis without ileal diversion. Ann Surg. 2000 Oct;232(4):530-41. doi: 10.1097/00000658-200010000-00008.

    PubMed 10998651
  • da Silva GM, Wexner SD, Gurland B, Gervaz P, Moon SD, Efron J, Nogueras JJ, Weiss EG, Vernava AM, Zmora O. Is routine pouchogram prior to ileostomy closure in colonic J-pouch really necessary? Colorectal Dis. 2004 Mar;6(2):117-20. doi: 10.1111/j.1463-1318.2004.00586.x.

    PubMed 15008910

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative and Ileal Pouches, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of pelvic collections in a representative sample of patients with normally functioning ileal pouches. (time frame: Baseline ( MRI scan)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02925260, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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