TY - JOUR
T1 - Fibrin Glue Is Effective Healing Perianal Fistulas in Patients with Crohn's Disease
AU - Grimaud, Jean Charles
AU - Munoz-Bongrand, Nicolas
AU - Siproudhis, Laurent
AU - Abramowitz, Laurent
AU - Sénéjoux, Agnès
AU - Vitton, Véronique
AU - Gambiez, Luc
AU - Flourié, Bernard
AU - Hébuterne, Xavier
AU - Louis, Edouard
AU - Coffin, Benoit
AU - De Parades, Vincent
AU - Savoye, Guillaume
AU - Soulé, Jean Claude
AU - Bouhnik, Yoram
AU - Colombel, Jean Frédéric
AU - Contou, Jean François
AU - François, Yves
AU - Mary, Jean Yves
AU - Lémann, Marc
N1 - Funding Information:
Conflicts of interest The authors disclose the following: Laurent Abramowitz received consulting fees for Nycomed SAS France; Xavier Hébuterne received funding from UCB Pharma for advisory activity, as a member on an advisory board, and from Abbott for educational activities; Edouard Louis, declared consulting fees or paid advisory board from Abbott, AstraZeneca, Ferring, Schering Plough, and UCB; Guillaume Savoye received lecture fees from Abbott Laboratories, Schering-Plough Corporation, and Ferring; Yoram Bouhnik declared consulting fees or paid advisory boards from Bristol-Myers Squibb, Shire, Sanofi, and Norgine Pharma, and received lecture fees from Abbott Laboratories, Astra Zeneca, Schering-Plough Corporation, Teva Pharmaceuticals, Ferring, Solvay-Pharma and Norgine; Jean-Frédéric Colombel declared consulting fees or paid advisory boards for Abbott Laboratories, Cellerix SL, Ocera Therapeutics, Schering-Plough Corporation, and UCB Pharma and received lecture fees for speaking at continuing medical education events indirectly sponsored by a commercial sponsor from Abbott Laboratories, Centocor, Schering-Plough Corporation, and UCB Pharma and grant support from Abbott Laboratories , Schering-Plough Corporation , UCB Pharma ; Marc Lémann declared consulting fees or paid advisory boards for Abbott Laboratories, Cellerix SL, Centocor, Schering-Plough Corporation, and UCB Pharma and received lecture fees from Abbott Laboratories, Schering-Plough Corporation, and UCB Pharma. All others authors disclose no conflicts.
Funding Information:
Funding Supported by grants from the Association François Aupetit (AFA) and from Nycomed SAS France , with the specific help of Patrick Loriquet, and Fibrin glue (Beriplast) was provided by Nycomed SAS, France.
PY - 2010/6
Y1 - 2010/6
N2 - Background & Aims: Fibrin glue is a therapeutic for fistulas that activates thrombin to form a fibrin clot, which mechanically seals the fistula tract. We assessed the efficacy and safety of a heterologous fibrin glue that was injected into the fistula tracts of patients with Crohn's disease (ClinicalTrials.gov No. NCT00723047). Methods: This multicenter, open-label, randomized controlled trial included patients with a Crohn's disease activity index ≤250 and fistulas between the anus (or low rectum) and perineum, vulva, or vagina, that drained for more than 2 months. Magnetic resonance imaging or endosonography was performed to assess fistula tracts and the absence of abscesses. Patients were stratified into groups with simple or complex fistulas and randomly assigned to receive fibrin glue injections (n = 36) or only observation (n = 41) after removal of setons. The primary end point was clinical remission at week 8, defined as the absence of draining, perianal pain, or abscesses. At week 8, a fibrin glue injection was offered to patients who were not in remission. Results: Clinical remission was observed in 13 of the 34 patients (38%) of the fibrin glue group compared with 6 of the 37 (16%) in the observation group; these findings demonstrate the benefit of fibrin glue (odds ratio, 3.2; 95% confidence interval: 1.1-9.8; P = .04). The benefit seemed to be greater in patients with simple fistulas. Four patients in the fibrin glue group and 6 in the observation group had adverse events. Conclusions: Fibrin glue injection is a simple, effective, and well-tolerated therapeutic option for patients with Crohn's disease and perianal fistula tracts.
AB - Background & Aims: Fibrin glue is a therapeutic for fistulas that activates thrombin to form a fibrin clot, which mechanically seals the fistula tract. We assessed the efficacy and safety of a heterologous fibrin glue that was injected into the fistula tracts of patients with Crohn's disease (ClinicalTrials.gov No. NCT00723047). Methods: This multicenter, open-label, randomized controlled trial included patients with a Crohn's disease activity index ≤250 and fistulas between the anus (or low rectum) and perineum, vulva, or vagina, that drained for more than 2 months. Magnetic resonance imaging or endosonography was performed to assess fistula tracts and the absence of abscesses. Patients were stratified into groups with simple or complex fistulas and randomly assigned to receive fibrin glue injections (n = 36) or only observation (n = 41) after removal of setons. The primary end point was clinical remission at week 8, defined as the absence of draining, perianal pain, or abscesses. At week 8, a fibrin glue injection was offered to patients who were not in remission. Results: Clinical remission was observed in 13 of the 34 patients (38%) of the fibrin glue group compared with 6 of the 37 (16%) in the observation group; these findings demonstrate the benefit of fibrin glue (odds ratio, 3.2; 95% confidence interval: 1.1-9.8; P = .04). The benefit seemed to be greater in patients with simple fistulas. Four patients in the fibrin glue group and 6 in the observation group had adverse events. Conclusions: Fibrin glue injection is a simple, effective, and well-tolerated therapeutic option for patients with Crohn's disease and perianal fistula tracts.
KW - Controlled Trial
KW - Crohn's Disease
KW - Fibrin Therapy
KW - Perianal Fistula
UR - http://www.scopus.com/inward/record.url?scp=77952715586&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2010.02.013
DO - 10.1053/j.gastro.2010.02.013
M3 - Article
C2 - 20178792
AN - SCOPUS:77952715586
SN - 0016-5085
VL - 138
SP - 2275-2281.e1
JO - Gastroenterology
JF - Gastroenterology
IS - 7
ER -