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This study will be a multicentre randomized controlled trial to assess the efficacy between balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of stenosis in Crohn´s Disease.
A Prospective, randomized, multicenter clinical trial.
Duration: Beginning in mid-2013 with a minimum of three years depending on the patient inclusion rate.
The participation of at least 20 hospitals in Spain with an inclusion of about 6 patients per hospital is required.
Calculation of sample size: The calculation of sample size was performed considering that the efficacy of endoscopic treatment by endoscopic stent placement is superior to endoscopic dilatation: 75% vs 50% for balloon dilation (% of patients free of therapeutic intervention -endoscopic or surgically a year follow-up).
For all 61 patients are required for each treatment group, the total of 122 patients. This calculation is made taking into account:
Schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placing a self-expanding metallic stent | Other | Placing a self-expanding metallic stent |
|
| A balloon dilatation | Other | A balloon dilatation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placing a self-expanding metallic stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up | To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of free patients of a new therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11). | one year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. | To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of patients free of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carme Loras, MD | Contact | +34-937365050 | 1215 | cloras@mutuaterrassa.es |
| MarÃa Esteve, MD | Contact | +34-937365050 | mestevecomas@telefonica.net |
| Name | Affiliation | Role |
|---|---|---|
| Carme Loras, MD | Hospital Universitari Mutua de Terrassa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Unversitari Mutua de Terrasa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12131607 | Background | Cosnes J, Cattan S, Blain A, Beaugerie L, Carbonnel F, Parc R, Gendre JP. Long-term evolution of disease behavior of Crohn's disease. Inflamm Bowel Dis. 2002 Jul;8(4):244-50. doi: 10.1097/00054725-200207000-00002. | |
| 2394349 | Background | Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6. |
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|
| A balloon dilatation | Device |
|
|
| At 6 months follow-up |
| Rate of complications related to the procedure. | Evaluate the safety and complications of both treatments Immediate complications related to the procedure:
Late complications related to the procedure:
| one year follow-up |
| The procedure total costs | Evaluate the costs of both treatments Study costs: The calculate procedure of diagnostic test (DT) cost is composed of some premises:
| one year follow-up |
| 15168367 | Background | Hommes DW, van Deventer SJ. Endoscopy in inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1561-73. doi: 10.1053/j.gastro.2004.03.023. |
| 10910235 | Background | Tichansky D, Cagir B, Yoo E, Marcus SM, Fry RD. Strictureplasty for Crohn's disease: meta-analysis. Dis Colon Rectum. 2000 Jul;43(7):911-9. doi: 10.1007/BF02237350. |
| 17903236 | Background | Hassan C, Zullo A, De Francesco V, Ierardi E, Giustini M, Pitidis A, Taggi F, Winn S, Morini S. Systematic review: Endoscopic dilatation in Crohn's disease. Aliment Pharmacol Ther. 2007 Dec;26(11-12):1457-64. doi: 10.1111/j.1365-2036.2007.03532.x. Epub 2007 Sep 28. |
| 19840991 | Background | Thienpont C, D'Hoore A, Vermeire S, Demedts I, Bisschops R, Coremans G, Rutgeerts P, Van Assche G. Long-term outcome of endoscopic dilatation in patients with Crohn's disease is not affected by disease activity or medical therapy. Gut. 2010 Mar;59(3):320-4. doi: 10.1136/gut.2009.180182. Epub 2009 Oct 19. |
| 10699786 | Background | Matsuhashi N, Nakajima A, Suzuki A, Yazaki Y, Takazoe M. Long-term outcome of non-surgical strictureplasty using metallic stents for intestinal strictures in Crohn's disease. Gastrointest Endosc. 2000 Mar;51(3):343-5. doi: 10.1016/s0016-5107(00)70366-x. No abstract available. |
| 9560118 | Background | Wholey MH, Levine EA, Ferral H, Castaneda-Zuniga W. Initial clinical experience with colonic stent placement. Am J Surg. 1998 Mar;175(3):194-7. doi: 10.1016/s0002-9610(97)00285-7. |
| 15164246 | Background | Suzuki N, Saunders BP, Thomas-Gibson S, Akle C, Marshall M, Halligan S. Colorectal stenting for malignant and benign disease: outcomes in colorectal stenting. Dis Colon Rectum. 2004 Jul;47(7):1201-7. doi: 10.1007/s10350-004-0556-5. Epub 2004 Jun 3. |
| 15868501 | Background | Wada H, Mochizuki Y, Takazoe M, Matsuhashi N, Kitou F, Fukushima T. A case of perforation and fistula formation resulting from metallic stent for sigmoid colon stricture in Crohn's disease. Tech Coloproctol. 2005 Apr;9(1):53-6. doi: 10.1007/s10151-005-0194-5. |
| 15785899 | Background | Bickston SJ, Foley E, Lawrence C, Rockoff T, Shaffer HA Jr, Yeaton P. Terminal ileal stricture in Crohn's disease: treatment using a metallic enteral endoprosthesis. Dis Colon Rectum. 2005 May;48(5):1081-5. doi: 10.1007/s10350-004-0865-8. |
| 17206082 | Background | Dafnis G. Repeated coaxial colonic stenting in the palliative management of benign colonic obstruction. Eur J Gastroenterol Hepatol. 2007 Jan;19(1):83-6. doi: 10.1097/MEG.0b013e32801222f9. |
| 17924567 | Background | Martines G, Ugenti I, Giovanni M, Memeo R, Iambrenghi OC. Anastomotic stricture in Crohn's disease: bridge to surgery using a metallic endoprosthesis. Inflamm Bowel Dis. 2008 Feb;14(2):291-2. doi: 10.1002/ibd.20268. No abstract available. |
| 17704890 | Background | Small AJ, Young-Fadok TM, Baron TH. Expandable metal stent placement for benign colorectal obstruction: outcomes for 23 cases. Surg Endosc. 2008 Feb;22(2):454-62. doi: 10.1007/s00464-007-9453-z. |
| 20205505 | Background | Keranen I, Lepisto A, Udd M, Halttunen J, Kylanpaa L. Outcome of patients after endoluminal stent placement for benign colorectal obstruction. Scand J Gastroenterol. 2010 Jun;45(6):725-31. doi: 10.3109/00365521003663696. |
| 22161935 | Background | Attar A, Maunoury V, Vahedi K, Vernier-Massouille G, Vida S, Bulois P, Colombel JF, Bouhnik Y; GETAID. Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: a prospective pilot study. Inflamm Bowel Dis. 2012 Oct;18(10):1849-54. doi: 10.1002/ibd.22844. Epub 2011 Dec 11. |
| 21542067 | Background | Levine RA, Wasvary H, Kadro O. Endoprosthetic management of refractory ileocolonic anastomotic strictures after resection for Crohn's disease: report of nine-year follow-up and review of the literature. Inflamm Bowel Dis. 2012 Mar;18(3):506-12. doi: 10.1002/ibd.21739. Epub 2011 May 3. |
| 22966851 | Background | Loras C, Perez-Roldan F, Gornals JB, Barrio J, Igea F, Gonzalez-Huix F, Gonzalez-Carro P, Perez-Miranda M, Espinos JC, Fernandez-Banares F, Esteve M. Endoscopic treatment with self-expanding metal stents for Crohn's disease strictures. Aliment Pharmacol Ther. 2012 Nov;36(9):833-9. doi: 10.1111/apt.12039. |
| 35065738 | Derived | Loras C, Andujar X, Gornals JB, Sanchiz V, Brullet E, Sicilia B, Martin-Arranz MD, Naranjo A, Barrio J, Duenas C, Foruny JR, Busquets D, Monfort D, Pineda JR, Gonzalez-Huix F, Perez-Roldan F, Pons V, Gonzalez B, Reyes Moreno J, Sainz E, Guardiola J, Bosca-Watts MM, Fernandez-Banares F, Mayor V, Esteve M; Grupo Espanol de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa (GETECCU). Self-expandable metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn's disease (ProtDilat study): an open-label, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):332-341. doi: 10.1016/S2468-1253(21)00386-1. Epub 2022 Jan 20. |
| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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