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Studies

Interventional Recruiting

NCT04330846 on ClinicalTrials.gov

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

Official title: 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)

  • Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
  • Enrollment: 40 (Estimated)
  • Study start: 2022-11-29 (Actual)
  • Primary completion: 2026-04-01 (Estimated)
  • Study completion: 2027-04-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: A prospective multicenter randomized comparative study of the treatment of de novo stenosis due to CD, comparing endoscopic treatment (stent or EBD) vs. surgical resection (SR). The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
  • Masking: None
  • PrimaryPurpose: Diagnostic

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 (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.

Conditions

  • Crohn Disease

Intervention / Treatment

  • Procedure: Surgical resection

Primary Outcome Measures

  • Quality of life of patients (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.

Countries

Spain

Locations and Investigators

  • Hospital Germans Trias i Pujol, Badalona, Spain (Not yet recruiting)
    • Ingrid Marin, MD (Principal Investigator)
  • Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain (Not yet recruiting)
    • Joan Gonals, MD (Principal Investigator)
  • Althaia, xarxa assistencial universitaria de Manresa, Manresa, Spain (Not yet recruiting)
    • Empar Sainz, MD (Principal Investigator)
  • Consorci Corporació Sanitària Parc Taulí, Sabadell, Spain (Recruiting)
    • Albert Villoria, MD (Principal Investigator)
  • Hospital Moisès Broggi, Sant Joan Despí, Spain (Not yet recruiting)
    • Mercè Navarro, MD (Principal Investigator)
  • Hospital Mutua de Terrassa, Terrassa, Spain (Recruiting)
    • Carme Loras, MD (Principal Investigator)
  • Hospital Universitario de Cáceres, Cáceres, Spain (Recruiting)
    • Carmen Dueñas, MD (Principal Investigator)
  • Clínica Girona, Girona, Spain (Not yet recruiting)
  • Hospital Josep Trueta, Girona, Spain (Not yet recruiting)
    • Xavier Aldeguer, Dr
    • David Busquets, MD (Principal Investigator)
  • Hospital de Inca, Inca, Spain (Not yet recruiting)
    • José Reyes, MD (Principal Investigator)
  • Hospital Universitari Arnau de Vilanova, Lleida, Spain (Recruiting)
    • Ferran Gonzalez-Huix, MD (Principal Investigator)
  • Hospital Universitario La Paz, Madrid, Spain (Not yet recruiting)
    • Mariló Martín, MD (Principal Investigator)
  • Hospital Universitario Ramon y Cajal, Madrid, Spain (Not yet recruiting)
    • Paco Mesonero, MD (Principal Investigator)
  • Hospital de Terrassa, Terrassa, Spain (Not yet recruiting)
    • David Monfort, MD (Principal Investigator)
  • Hospital Clínico de Valencia, Valencia, Spain (Not yet recruiting)
    • MÍGUEL MÍNGUEZ PÉREZ, MD (Principal Investigator)
    • Maia Boscó, MD
    • Vicente Sanchiz, MD
  • Hospital Universitari La Fe, Valencia, Spain (Recruiting)
    • Elena Cerrillo, MD (Principal Investigator)

Study Officials

  • Carme Loras (Principal Investigator) — Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa