Clinical trial NCT00723047: Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Official title: Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Patients
CD complicated
least
One perianal fistula
Draining
2 months duration
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
Collaborators: name: Nycomed
name: Société Nationale Française de Gastroentérologie
First posted: 2008-07-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* CD confirmed by endoscopy and histology.
* CDAI should be 250 or less
* at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration

Exclusion Criteria:

* treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months
* presence of a perianal abscess (\>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month,
* presence of anal or rectal stenosis,
* surgery during the previous month (except seton removal),
* previous fibrin glue injection,
* pregnancy.

Primary outcomes:
measure: Clinical Remission
timeFrame: 8 weeks after inclusion
Secondary outcomes:
measure: Early Clinical Remission
timeFrame: 4 weeks after Inclusion
measure: Occurrence of perianal abcess
timeFrame: During whole study
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Sart Tilman University Hospital
city: Clichy
country: France
facility: Beaujon Hospital
city: Colombes
country: France
facility: Louis Mourrier Hospital
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Marseille North Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Paris
country: France
facility: Hopital St Louis
city: Paris
country: France
facility: Lariboisiere Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Paris
country: France
facility: Bichat Hospital
city: Pierre Benite
country: France
facility: Lyon Sud University Hospital
city: Rennes
country: France
facility: Pontchaillou University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Tours
country: France
facility: Trousseau University Hospital
Study officials:
References:
citation: Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
citation: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
citation: Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.
citation: Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
citation: Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.
citation: Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. doi: 10.7326/0003-4819-123-2-199507150-00009.
citation: Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Senejoux A, Vitton V, Gambiez L, Flourie B, Hebuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soule JC, Bouhnik Y, Colombel JF, Contou JF, Francois Y, Mary JY, Lemann M; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.