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

February 23, 2023 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Crohn's Disease. Endoscopic Treatment (Self-expanding Metal Prosthesis/Ballon Dilation) vc Surgical Resection (ENDOCIR STUDY)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In many cases, a surgical approach allows for the removal of the entire inflamed intestine. However, the percentage of post-surgical recurrence per year after surgery is 80-85% (7), decreasing to 40% in patients who begin preventive immunosuppressive treatment in the immediate post-surgery period (8). This means that more than 40% of patients will require combined immunosuppression to keep CD under control one year after surgery. Endoscopic treatment does not remove the affected intestine. However, it has a long-term therapeutic efficacy of 50-60% with a very low percentage of complications (4-6%).

A large number of studies have shown that patients' quality of life improves when CD is properly controlled, either through medical or surgical treatment (9). However, there are no studies evaluating the quality of life of patients after endoscopic treatment.

Neither are there comparative studies of the costs of the two procedures. However, a recent study comparing the cost of 38 endoscopic procedures with their surgical equivalent suggested that, in most cases, the cost of endoscopic treatment is four times lower (10).

The European Crohn's and Colitis Organization (ECCO) guidelines on the management of de novo stenosis in patients with CD recommend surgery as the first option, based on expert opinion (Level of Evidence 4), although there are no studies comparing the two treatment modalities (11,12).

A Spanish multicenter study coordinated by researchers involved in the present project (Andujar X, et al)(13), which included the largest published series of endoscopic treatment with dilation in patients with CD to date, shows that therapeutic success with EBD in de novo stenoses is achieved in a large percentage of cases, with results similar to those obtained in post-surgical stenoses (73% vs 84%).

In addition, CD stenoses can be treated effectively with self-expanding metal stents (SEMS), and it has been suggested that these may be particularly indicated in patients who are refractory to balloon dilation, including both de novo and anastomotic stenosis patients (14-17). Therefore, in order to compare the efficacy of these two endoscopic treatments, the PROTDILAT study (IP: C Loras. Project FIS nº Pl13/01226 and Clinical Trials. Gov nº NCT02395354) was designed, and is currently in the final manuscript writing phase (100 patients included). The final results (Andújar X, UEGW 2019)(18) confirm that both procedures are effective and safe in the treatment of both post-surgical and de novo stenosis, while showing the therapeutic superiority of EBD over SEMS when the results are evaluated globally (80.5 vs 51.3 %; primary end point). However, this difference is not observed in the subanalysis of patients with stenosis ≥4 cm (LBD: 66.7% vs PMA: 63.6%) but with a significantly lower cost in EDB treatment (EDB 1,212.41 euros vs PMA 3,615.07 euros). Therefore, SEMS may have a role to play in longer stenosis in which EBD has proven to be less efficacious.

This work has been conceived as an exploratory proof of concept study, given that there are currently no studies comparing surgical and endoscopic approaches and it is therefore difficult to calculate the adequate sample size.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Cáceres, Spain
        • Not yet recruiting
        • Hospital Universitario de Cáceres
        • Principal Investigator:
          • Carmen Dueñas, MD
      • Girona, Spain
        • Not yet recruiting
        • Clinica Girona
      • Girona, Spain
        • Not yet recruiting
        • Hospital Josep Trueta
        • Contact:
          • Xavier Aldeguer, Dr
        • Principal Investigator:
          • David Busquets, MD
      • Inca, Spain
        • Not yet recruiting
        • Hospital de Inca
        • Principal Investigator:
          • José Reyes, MD
      • Lleida, Spain, 25198
        • Not yet recruiting
        • Hospital Universitari Arnau de Vilanova
        • Principal Investigator:
          • Ferran Gonzalez-Huix, MD
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Mariló Martín, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramon Y Cajal
        • Principal Investigator:
          • Paco Mesonero, MD
      • Terrassa, Spain
        • Not yet recruiting
        • Hospital de Terrassa
        • Principal Investigator:
          • David Monfort, MD
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico de Valencia
        • Principal Investigator:
          • MÍGUEL MÍNGUEZ PÉREZ, MD
        • Sub-Investigator:
          • Maia Boscó, MD
        • Sub-Investigator:
          • Vicente Sanchiz, MD
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitari La Fe
        • Principal Investigator:
          • Elena Cerrillo, MD
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias i Pujol
        • Principal Investigator:
          • Ingrid Marin, MD
      • Hospitalet de Llobregat, Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitario de Bellvitge
        • Principal Investigator:
          • Joan Gonals, MD
      • Manresa, Barcelona, Spain, 08243
        • Not yet recruiting
        • ALTHAIA, Xarxa Assistencial Universitària de Manresa
        • Principal Investigator:
          • Empar Sainz, MD
      • Sabadell, Barcelona, Spain, 08208
        • Not yet recruiting
        • Consorci Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Albert Villoria, MD
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Not yet recruiting
        • Hospital Moisés Broggi
        • Principal Investigator:
          • Mercè Navarro, MD
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Mutua De Terrassa
        • Principal Investigator:
          • Carme Loras, MD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBD group
  • Post-procedural admission in the Short Stay Unit (SSU).
  • Superficial sedation by endoscopist or anesthesiologist depending on the center.
  • Pneumatic balloon type CRE Boston scientific®; diameter of the balloon at the endoscopist's discretion.
  • A maximum of 2 dilations will be performed with a minimum interval of 15-30 days between each dilation.
  • Dilation failure will be considered if > 2 dilations are required.
Procedure: Surgical resection
The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
Experimental: SEMS group
  • Post-procedural admission in the Short Stay Unit (SSU).
  • Superficial sedation by endoscopist or anesthesiologist depending on the center.
  • Fully coated, self-expanding Tae Woong medical®-type metal prostheses; size of the prostheses at the discretion of the endoscopist
  • Clips can be placed at the distal end of the prosthesis at the endoscopist's discretion.
  • Removal time of the prosthesis 4 weeks.
Procedure: Surgical resection
The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients
Time Frame: One year of follow-up
Percentage of patients with an increase of more than 30 points in the Inflammatory Bowel Disease Questionnaire (IBDQ-32) quality of life index. The higher the better.
One year of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with clinical recurrence
Time Frame: One year of follow-up
Percentage of patients with clinical recurrence (scale of obstructive symptoms 0-6) and costs. The lower the better.
One year of follow-up
Percentage of complications
Time Frame: One year of follow-up
Percentage of complications and costs.
One year of follow-up

Collaborators and Investigators

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

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Investigators

  • Principal Investigator: Carme Loras, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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)

November 29, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOCIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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