Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT04330846
Recruiting Not applicable

Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.

NCT04330846 · tracked via the Priya Life Science Spain tracker
Sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Phase
Not applicable
Started
2022-11-29
Last updated
2025-08-19

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Surgical resection

Surgical resection: The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.

Study summary

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 (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 18-80 years of age. * Crohn's disease with predominantly de novo fibrotic stenosis\* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy). * Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion. * Symptomatology of intestinal occlusion-subocclusion. * Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach). * Stenosis length \< 10 cm. * Maximum of 2 stenoses. * Informed consent from patient. Exclusion Criteria: * No informed consent from the patient. * Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis. * Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion. * Pregnancy or lactation. * Any clinical situation that prevents the performance of endoscopy or surgery. * Stenosis not accessible by endoscopy. * Asymptomatic patient. * Stenosis length ≥ 10 cm. * Presents with \> 2 stenoses. * Severe coagulation disorders (platelets \< 70000; INR \> 1.8).

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Hospital Germans Trias i Pujol Badalona Barcelona Not Yet Recruiting
Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Barcelona Not Yet Recruiting
Althaia, xarxa assistencial universitaria de Manresa Manresa Barcelona Not Yet Recruiting
Consorci Corporació Sanitària Parc Taulí Sabadell Barcelona Recruiting
Hospital Moisès Broggi Sant Joan Despí Barcelona Not Yet Recruiting
Hospital Mutua de Terrassa Terrassa Barcelona Recruiting
Hospital Universitario de Cáceres Cáceres Spain Recruiting
Clínica Girona Girona Spain Not Yet Recruiting
Hospital Josep Trueta Girona Spain Not Yet Recruiting
Hospital de Inca Inca Spain Not Yet Recruiting
Hospital Universitari Arnau de Vilanova Lleida Spain Recruiting
Hospital Universitario La Paz Madrid Spain Not Yet Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Not Yet Recruiting
Hospital de Terrassa Terrassa Spain Not Yet Recruiting
Hospital Clínico de Valencia Valencia Spain Not Yet Recruiting
Hospital Universitari La Fe Valencia Spain Recruiting

More Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa trials in Spain

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry) Recruiting
Impact of IBD Activity on Frailty in Patients Over 60 Years Recruiting
Immunological Characteristics of Preclinical IBD Recruiting

Other trials for the same condition

Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease Active, not recruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Recruiting
De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease Enrolling by invitation
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04330846 on ClinicalTrials.gov ↗ ← All trials in Spain