Clinical trial NCT06036680: Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Stenosis
Keywords: endoscopic balloon dilatation
self-expanding metal stent
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
Collaborators: name: Clínica Girona
name: Complejo Hospitalario Universitario de Vigo
name: Consorcio Hospital Universitario Clinico de Valencia
name: Hospital Clinic of Barcelona
name: Hospital Comarcal de Inca
name: Hospital de Terrassa
name: Hospital General la Mancha-Centro
name: Parc Taulí Hospital Universitari
name: Hospital Universitario Ramón y Cajal
name: Hospital Universitario Reina Sofía
name: Hospital Universitari de Bellvitge
name: Hospital Universitari Dr Josep Trueta
name: Hospital Universitario La Fe
name: Hospital Universitari Arnau de Vilanova
name: Hospital Universitario de Burgos
name: Hospital Universitario de Cáceres
name: Hospital Universitario La Paz
name: Hospital Universitario Rio Hortega
First posted: 2023-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients included in the ProtDilat study that finished the follow-up

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of surgery-free patients post-treatment
timeFrame: end of long-term follow up (median 7 years post-treatment)
Secondary outcomes:
measure: Percentage of patients that have not required any endoscopic retreatment
timeFrame: end of long-term follow up (median 7 years post-treatment)
measure: Long-term effectiveness of endoscopic treatment (SEMS vs EBD): percentage of patients free of surgery and who have not required any endoscopic retreatment
timeFrame: end of long-term follow up (median 7 years post-treatment)
measure: Percentage of patients with safety issues and/or complications related to endoscopic or surgical treatment
timeFrame: end of long-term follow up (median 7 years post-treatment)
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
Study officials:
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