Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
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)
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
40 participants
Nov 29, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria10
- 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).
Interventions
The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
Locations(16)
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NCT04330846