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

September 12, 2023 updated by: Hospital Mutua de Terrassa

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mutua Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

CD patients included in the ProtDilat study that finished the follow-up

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endoscopic balloon dilatation (EBD) treated CD patients
Self-expandable metal stent (SEMS) treated CD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of surgery-free patients post-treatment
Time Frame: end of long-term follow up (median 7 years post-treatment)
end of long-term follow up (median 7 years post-treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients that have not required any endoscopic retreatment
Time Frame: end of long-term follow up (median 7 years post-treatment)
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
Time Frame: end of long-term follow up (median 7 years post-treatment)
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
Time Frame: end of long-term follow up (median 7 years post-treatment)
end of long-term follow up (median 7 years post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Mutua de Terrassa

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Estimated)

September 15, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long-ProtDilat 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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