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

Crohn's Disease Clinical Trial

— PROTDILAT  

Official title:

Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02395354
• Other study ID #: ProtDilat-3-2013
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2015
• Last updated: April 11, 2018
• Start date: September 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Contact: Carme Loras, MD
• Phone: +34-937365050
• Email: cloras[@]mutuaterrassa.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

• Bilateral Contrast: any two samples may be superior in terms of efficacy.

• Error type I: 0.05

• Error type II: 0.20 (statistical power 80%)

• Percentage of efficacy at one year follow-up: 75% in the prosthetic group and 50% in the balloon dilatation group

• Percentage of losses: 5%.

Schedule

1. Screening Visit

2. Sheet Inclusion

3. Expansion notebook / prosthesis placement notebook

4. Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment.

5. Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet

6. Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment.

7. Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment.

8. Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment

9. Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment

10. Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical

11. Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment

12. Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment

13. Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment

14. Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment

15. Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment

16. Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical.

17. Final assessment.

18. Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: December 31, 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Chronic Inflammation
• Constriction, Pathologic
• Crohn Disease
• Crohn's Disease
• Inflammation
• Stenosis

Intervention

Device:
• Placing a self-expanding metallic stent
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.
• A balloon dilatation
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.

Locations

Country	Name	City	State
Spain	Hospital Unversitari Mutua de Terrasa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

Dafnis G. Repeated coaxial colonic stenting in the palliative management of benign colonic obstruction. Eur J Gastroenterol Hepatol. 2007 Jan;19(1):83-6. — View Citation

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. Epub 2007 Sep 28. Review. — View Citation

Hommes DW, van Deventer SJ. Endoscopy in inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1561-73. Review. — View Citation

Keränen I, Lepistö A, Udd M, Halttunen J, Kylänpää 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. — View Citation

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. Review. — View Citation

Loras C, Pérez-Roldan F, Gornals JB, Barrio J, Igea F, González-Huix F, González-Carro P, Pérez-Miranda M, Espinós JC, Fernández-Bañares F, Esteve M. Endoscopic treatment with self-expanding metal stents for Crohn’s disease strictures. Aliment Pharmacol Ther. 2012 Nov;36(9):833-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Jun 3. — View Citation

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. Erratum in: Gut. 2010 Jul;59(7):1007. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	At 6 months follow-up
Secondary	Rate of complications related to the procedure.	Evaluate the safety and complications of both treatments; Immediate complications related to the procedure: Inhaled into the lungs.; Respiratory depression O2 Sat <90%; Cardiorespiratory arrest; Arrhythmia; Allergic reaction; Pain; Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet).; Piercing: endoscopic treatment / surgery treatment; Exitus; Others; Late complications related to the procedure: Pain; Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet).; Piercing: endoscopic treatment / surgery treatment; Exitus; Others	one year follow-up
Secondary	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: Calculate the test unit cost; Accounting for all costs associated with DT Direct and Indirect Costs	one year follow-up