Crohn Disease Clinical Trial
— Long-ProtDilatOfficial title:
Long-term Follow-up ProtDilat Study; Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Self-expandable Metal Stent vs. Endoscopic Balloon Dilatation
Verified date | September 2023 |
Source | Hospital Mutua de Terrassa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications. The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis > 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros). Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial. The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis < 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age18-75. - CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy). - Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic. - Intestinal occlusion or sub-occlusion symptomatology. - Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale). - Stenosis length < 10 cm. - Maximum 2 stenoses. - Informed consent of patient. Exclusion Criteria: - No informed consent of patient. - Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area. - Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic. - Pregnancy or lactation. - Any clinical condition that prevents the performance of endoscopy. - Stenosis inaccessible by colonoscopy. - No obstructive symptoms. - Stenosis length = 10 cm. - Presenting more than 2 stenoses. - Serious coagulation disorder (platelets < 70000; INR > 1.5) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Mutua Terrassa | Terrassa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Mutua de Terrassa | Clínica Girona, Complejo Hospitalario Universitario de Vigo, Consorcio Hospital Universitario Clinico de Valencia, Hospital Clinic of Barcelona, Hospital Comarcal de Inca, Hospital de Terrassa, Hospital General la Mancha-Centro, Hospital Universitari Arnau de Vilanova, Hospital Universitari de Bellvitge, Hospital Universitari Dr Josep Trueta, Hospital Universitario de Burgos, Hospital Universitario de Cáceres, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario Ramón y Cajal, Hospital Universitario Reina Sofía, Hospital Universitario Rio Hortega, Parc Taulí Hospital Universitari |
Spain,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of surgery-free patients post-treatment | end of long-term follow up (median 7 years post-treatment) | ||
Secondary | Percentage of patients that have not required any endoscopic retreatment | end of long-term follow up (median 7 years post-treatment) | ||
Secondary | Long-term effectiveness of endoscopic treatment (SEMS vs EBD): percentage of patients free of surgery and who have not required any endoscopic retreatment | end of long-term follow up (median 7 years post-treatment) | ||
Secondary | Percentage of patients with safety issues and/or complications related to endoscopic or surgical treatment | end of long-term follow up (median 7 years post-treatment) |
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