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

Colitis, Ulcerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925260
• Other study ID #: mripouchesv1.11808216
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: February 2020
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ileal Pouches

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital	London	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (20)

Bach SP, Mortensen NJ. Revolution and evolution: 30 years of ileoanal pouch surgery. Inflamm Bowel Dis. 2006 Feb;12(2):131-45. Review. — View Citation

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. — View Citation

Flusberg M, Sahni VA, Erturk SM, Mortele KJ. Dynamic MR defecography: assessment of the usefulness of the defecation phase. AJR Am J Roentgenol. 2011 Apr;196(4):W394-9. doi: 10.2214/AJR.10.4445. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Myrelid P, Øresland 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. — View Citation

Nadgir RN, Soto JA, Dendrinos K, Lucey BC, Becker JM, Farraye FA. MRI of complicated pouchitis. AJR Am J Roentgenol. 2006 Oct;187(4):W386-91. — View Citation

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

Øresland 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. — View Citation

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. — View Citation

Parks AG, Nicholls RJ, Belliveau P. Proctocolectomy with ileal reservoir and anal anastomosis. Br J Surg [Internet]. John Wiley & Sons, Ltd.; 1980;67(8):533-8. Available from: http://dx.doi.org/10.1002/bjs.1800670802

Parks AG, Nicholls RJ. Proctocolectomy without ileostomy for ulcerative colitis. Br Med J. 1978 Jul 8;2(6130):85-8. — View Citation

R. M, N. S, M. B, E. R. Pouch function and quality of life after successful management of pouch-related septic complications in patients with ulcerative colitis [Internet]. Langenbeck's Archives of Surgery. R. Mennigen, Department of General and Visceral Surgery, University Hospital Muenster, Waldeyerstr. 1, Muenster 48149, Germany. E-mail: rudolf.mennigen@ukmuenster.de: Springer Verlag (Tiergartenstrasse 17, Heidelberg D-69121, Germany); 2012. p. 37-44. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed10&NEWS=N&AN=2011655737

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. — View Citation

Ryoo S-B, Oh H-K, Han EC, Ha H-K, Moon SH, Choe EK, et al. Complications after ileal pouch-anal anastomosis in Korean patients with ulcerative colitis. World J Gastroenterol [Internet]. United States: Ryoo,Seung-Bum. Seung-Bum Ryoo, Heung-Kwon Oh, Eon Chul Han, Heon-Kyun Ha, Sang Hui Moon, Eun Kyung Choe, Kyu Joo Park, Division of Colorectal Surgery, Department of Surgery, Seoul National University College of Medicine, Seoul 110-744, South Korea.; 2014;20(23):7488-96. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=24966620

Sherman J, Greenstein AJ, Greenstein AJ. Ileal j pouch complications and surgical solutions: a review. Inflamm Bowel Dis [Internet]. United States: Sherman,Jingjing. Division of Colorectal Surgery, Department of Surgery, The Icahn School of Medicine at Mount Sinai, New York, New York.; 2014;20(9):1678-85. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=24983986

Soto J a, Gupta A, Broder JC, Tkacz JN, Anderson SW, Soto J a, et al. Ileal pouch-anal anastomosis surgery: imaging and intervention for post-operative complications. Radiographics [Internet]. United States: Broder,Jennifer C. Department of Radiology, Boston University Medical Center and Boston University, 820 Harrison Avenue, Boston, MA 02118, USA. jennifer.broder@bmc.org; 2010;30(1):221-33. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med5&NEWS=N&AN=20083595

Stellingwerf ME, Maeda Y, Patel U, Vaizey CJ, Warusavitarne J, Bemelman WA, Clark SK. The role of the defaecating pouchogram in the assessment of evacuation difficulty after restorative proctocolectomy and pouch-anal anastomosis. Colorectal Dis. 2016 Aug;18(8):O292-300. doi: 10.1111/codi.13431. — View Citation

Sugerman HJ, Sugerman EL, Meador JG, Newsome HHJ, Kellum JMJ, DeMaria EJ. Ileal pouch anal anastomosis without ileal diversion. Ann Surg [Internet]. UNITED STATES: Sugerman,H J. General/Trauma Surgery Division, Department of Surgery, Medical College of Virginia of Virginia Commonwealth University, Richmond, Virginia, USA. hsugerma@hsc.vcu.edu; 2000;232(4):530-41. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med4&NEWS=N&AN=10998651

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of pelvic collections in a representative sample of patients with normally functioning ileal pouches.		Baseline ( MRI scan)
Secondary	A descriptive assessment of the normal variation of ileal pouches on MRI scans.		Baseline ( MRI scan)
Secondary	Assess the patient experience of MRI pouchography using enemas	Non-validated questionnaire assessment of patient anxiety, comfort, embarrassment and confidence in the outcome.	Baseline ( MRI scan)