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)

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital Universitario de Cáceres
RECRUITING
Cáceres
Clínica Girona
NOT_YET_RECRUITING
Girona
Hospital Josep Trueta
NOT_YET_RECRUITING
Girona
Hospital de Inca
NOT_YET_RECRUITING
Inca
Hospital Universitario de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
NOT_YET_RECRUITING
Madrid
Althaia, xarxa assistencial universitaria de Manresa
NOT_YET_RECRUITING
Manresa
Consorci Corporació Sanitària Parc Taulí
RECRUITING
Sabadell
Hospital Moisès Broggi
NOT_YET_RECRUITING
Sant Joan Despí
Hospital de Terrassa
NOT_YET_RECRUITING
Terrassa
Hospital Mutua de Terrassa
RECRUITING
Terrassa
Hospital Clínico de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitari La Fe
RECRUITING
Valencia
Contact Information
Primary
Anna Casas
secretariacientifica2@geteccu.org
635 899 553
Backup
Eugeni Domènech
eugenidomenech@gmail.com
Time Frame
Start Date: 2022-11-29
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 40
Treatments
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.
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.
Sponsors
Leads: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This content was sourced from clinicaltrials.gov