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

Sponsor

Hospital Mutua de Terrassa (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06036680

Collaborator

Clínica Girona (Other), Complejo Hospitalario Universitario de Vigo (Other), Consorcio Hospital Universitario Clinico de Valencia (Other), Hospital Clinic of Barcelona (Other), Hospital Comarcal de Inca (Other), Hospital de Terrassa (Other), Hospital General la Mancha-Centro (Other), Parc Taulí Hospital Universitari (Other), Hospital Universitario Ramón y Cajal (Other), Hospital Universitario Reina Sofía (Other), Hospital Universitari de Bellvitge (Other), Hospital Universitari Dr Josep Trueta (Other), Hospital Universitario La Fe (Other), Hospital Universitari Arnau de Vilanova (Other), Hospital Universitario de Burgos (Other), Hospital Universitario de Cáceres (Other), Hospital Universitario La Paz (Other), Hospital Universitario Rio Hortega (Other)

Enrollment

Location

12.4

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease Stenosis

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Dec 19, 2022

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Endoscopic balloon dilatation (EBD) treated CD patients
Self-expandable metal stent (SEMS) treated CD patients

Outcome Measures

Primary Outcome Measures

Percentage of surgery-free patients post-treatment [end of long-term follow up (median 7 years post-treatment)]

Secondary Outcome Measures

Percentage of patients that have not required any endoscopic retreatment [end of long-term follow up (median 7 years post-treatment)]
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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona	Spain	08221

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hospital Mutua de Terrassa

ClinicalTrials.gov Identifier:

NCT06036680

Other Study ID Numbers:

Long-ProtDilat 1

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Mutua de Terrassa

endoscopic balloon dilatation

self-expanding metal stent

Additional relevant MeSH terms:

Crohn Disease

Constriction, Pathologic

Study Results

No Results Posted as of Sep 14, 2023