Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

NCT02395354 | Unknown

• 1 other identifier: ProtDilat-3-2013
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stenosis; Crohn's Disease; Chronic Inflammation

Keywords

Endoscopic treatment; Stenosis; Crohn's Disease; balloon dilatation; self-expanding metallic stent; chronic transmural inflammation; steady narrowing of the intestinal lumen

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.

  At 6 months follow-up

• Rate of complications related to the procedure.

  one year follow-up

• The procedure total costs

  one year follow-up

Study Arms (2)

Placing a self-expanding metallic stent

OTHER

Placing a self-expanding metallic stent

Device: Placing a self-expanding metallic stent

A balloon dilatation

OTHER

A balloon dilatation

Device: A balloon dilatation

Interventions

Placing a self-expanding metallic stent DEVICE

* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center * Fully covered self-expanding metal stents Tae Woong Medical® type; prosthesis size at the endoscopist discretion * Clips can be placed at the distal end of the prosthesis according to the endoscopist. * Prosthesis removal time in 4 weeks.

Placing a self-expanding metallic stent

A balloon dilatation DEVICE

* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center. * Pneumatic ball type CRE Boston cientific®; balloon diameter at the endoscopist discretion * Up to 2 expansion will be made with a minimum interval between 15-30 days between each expansion * It shall be deemed failure to expansion if required\> 2 expansions.

A balloon dilatation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Crohn's Disease with a predominantly fibrotic stenosis de novo and / or post- surgical confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
• Patients with stenosis already known and previously treated with stent and / or dilation with\> 1 Year asymptomatic
• Symptoms of intestinal partial occlusion
• Refractory to Conventional medical treatment (no response to usual therapeutic range "accelerated step-up").
• Length of stenosis \<10 cm.
• Submit a maximum of 2 stenosis.
• Patient Informed consent

You may not qualify if:

• No patient Informed consent.
• Stenosis complicated with abscess, fistula or important activity associated with your EC not limited to the stenosis area.
• Patients with stenosis already known and previously treated with stent and / or dilation with \<1 year asymptomatic.
• Pregnancy and lactation
• Any clinical situation that prevents the performance of endoscopy
• Stenosis not accessible by endoscopy
• Asymptomatic patient
• Length of stenosis ≥ 10 cm.
• Submit\> 2 stenosis.
• Severe coagulation disorders (platelets \<70000; INR\> 1.8)

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (1)

Hospital Unversitari Mutua de Terrasa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Related Publications (19)

• 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.

  PMID: 12131607 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.

  PMID: 2394349 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.

  PMID: 15168367 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.

  PMID: 10910235 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.

  PMID: 17903236 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.

  PMID: 19840991 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.

  PMID: 10699786 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.

  PMID: 9560118 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.

  PMID: 15164246 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.

  PMID: 15868501 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.

  PMID: 15785899 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.

  PMID: 17206082 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.

  PMID: 17924567 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.

  PMID: 17704890 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.

  PMID: 20205505 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.

  PMID: 22161935 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.

  PMID: 21542067 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.

  PMID: 22966851 BACKGROUND

• 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.

  PMID: 35065738 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic; Crohn Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Carme Loras, MD

  Hospital Universitari Mutua de Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carme Loras, MD

CONTACT

+34-937365050; cloras@mutuaterrassa.es

María Esteve, MD

CONTACT

+34-937365050; mestevecomas@telefonica.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: September 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: December 31, 2018
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

ES (1)