Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

NCT ID: NCT06036680

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2023-12-31

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.

Conditions

Crohn Disease; Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Endoscopic balloon dilatation (EBD) treated CD patients

No interventions assigned to this group

Self-expandable metal stent (SEMS) treated CD patients

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica Girona

UNKNOWN

Sponsor Role: collaborator

Complejo Hospitalario Universitario de Vigo

OTHER

Sponsor Role: collaborator

Consorcio Hospital Universitario Clinico de Valencia

UNKNOWN

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Hospital Comarcal de Inca

OTHER

Sponsor Role: collaborator

Hospital de Terrassa

OTHER

Sponsor Role: collaborator

Hospital General la Mancha-Centro

UNKNOWN

Sponsor Role: collaborator

Parc Taulí Hospital Universitari

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramón y Cajal

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario Reina Sofía

UNKNOWN

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: collaborator

University Hospital of Girona Dr. Josep Trueta

NETWORK

Sponsor Role: collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Hospital Universitari Arnau de Vilanova

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario de Burgos

OTHER

Sponsor Role: collaborator

Hospital Universitario de Cáceres

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role: collaborator

Hospital Universitario Rio Hortega

UNKNOWN

Sponsor Role: collaborator

Hospital Mutua de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Countries

Spain

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Other Identifiers

Long-ProtDilat 1

Identifier Type: -

Identifier Source: org_study_id