StenosisPROTDILATNCT02395354
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
A study testing Placing a self-expanding metallic stent and A balloon dilatation in people with Stenosis and Crohn's Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stenosis, Crohn's Disease, Chronic Inflammation
- What is being tested?
- Placing a self-expanding metallic stent and A balloon dilatation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Asymptomatic patient
- Length of stenosis ≥ 10 cm.
- Submit> 2 stenosis.
- Severe coagulation disorders (platelets <70000; INR> 1.8)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Unversitari Mutua de Terrasa
Terrassa, Barcelona, 08221
Carme Loras, MD, +34937365050 ext. 1215, cloras@mutuaterrassa.es
Maria Esteve, MD, +34937365050, mestevecomas@telefonica.net
About this study
Official title: Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation
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.
Read the detailed 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
- Screening Visit
- Sheet Inclusion
- Expansion notebook / prosthesis placement notebook
- Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet
- Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical
- Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical.
- Final assessment.
- Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical
- Conditions
- Stenosis, Crohn's Disease, Chronic Inflammation
- Being tested
- Placing a self-expanding metallic stent, A balloon dilatation
- Keywords
- Endoscopic treatment, Stenosis, Crohn's Disease, balloon dilatation, self-expanding metallic stent, chronic transmural inflammation, steady narrowing of the intestinal lumen
- Medical subject headings
- Constriction, Pathologic, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placing a self-expanding metallic stentDevice
- 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 dilatationDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Placing a self-expanding metallic stent | Other | Placing a self-expanding metallic stent Receives: Device: Placing a self-expanding metallic stent |
| A balloon dilatation | Other | A balloon dilatation Receives: Device: A balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 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:
- None
- 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
Measured: 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:
- Calculate the test unit cost
- Accounting for all costs associated with DT Direct and Indirect Costs
Measured: one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carme Loras, MD, Principal investigator, Hospital Universitari Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395354
- Sponsor's protocol ID
- ProtDilat-3-2013
- Acronym
- PROTDILAT
- Status last verified
- Apr 2018
- First submitted
- 17 Mar 2015
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12131607Rutgeerts 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.
PubMed 2394349Hommes DW, van Deventer SJ. Endoscopy in inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1561-73. doi: 10.1053/j.gastro.2004.03.023.
PubMed 15168367Tichansky 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.
PubMed 10910235Hassan 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.
PubMed 17903236Thienpont 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.
PubMed 19840991Matsuhashi 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.
PubMed 10699786Wholey 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.
PubMed 9560118Suzuki 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.
PubMed 15164246Wada 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.
PubMed 15868501Bickston 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.
PubMed 15785899Dafnis 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.
PubMed 17206082Martines 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.
PubMed 17924567Small 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.
PubMed 17704890Keranen 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.
PubMed 20205505
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation
- ClinicalTrials.gov ID
- NCT02395354
- Acronym / sponsor ID
- PROTDILAT / ProtDilat-3-2013
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Screening Visit
- Sheet Inclusion
- Expansion notebook / prosthesis placement notebook
- Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet
- Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment.
- Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical
- Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment
- Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical.
- Final assessment.
- Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placing a self-expanding metallic stent | Other | Device: Placing a self-expanding metallic stentPlacing a self-expanding metallic stent |
| A balloon dilatation | Other | Device: A balloon dilatationA balloon dilatation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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").
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Placing a self-expanding metallic stent |
| 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. | Device | A balloon dilatation |
Primary outcome
Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
Time frame: 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).
3 secondary outcomes
Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.
Time frame: At 6 months follow-up
Rate of complications related to the procedure.
Time frame: one year follow-up
The procedure total costs
Time frame: one year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Background: PubMed 12131607Cosnes 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.
- Background: PubMed 2394349Rutgeerts 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.
- Background: PubMed 15168367Hommes DW, van Deventer SJ. Endoscopy in inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1561-73. doi: 10.1053/j.gastro.2004.03.023.
- Background: PubMed 10910235Tichansky 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.
- Background: PubMed 17903236Hassan 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.
- Background: PubMed 19840991Thienpont 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.
- Background: PubMed 10699786Matsuhashi 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.
- Background: PubMed 9560118Wholey 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.
- Background: PubMed 15164246Suzuki 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.
- Background: PubMed 15868501Wada 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.
- Background: PubMed 15785899Bickston 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.
- Background: PubMed 17206082Dafnis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Loras, MD principal investigator
Hospital Universitari Mutua de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placing a self-expanding metallic stent and A balloon dilatation in people with Stenosis and Crohn's Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carme Loras, MD (+34-937365050 ext. 1215, cloras@mutuaterrassa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up (time frame: one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395354, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.