Table 1.

Selection criteria

Inclusion criteria:

Patients eligible for the trial must comply with all of the following at randomization

- 18–80 years of age.

- Crohn’s disease with predominantly de novo fibrotic stenosisa confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscope).

- Patients with known stenosis previously treated with stenting and/or dilation performed over 1 year before the date of inclusion.

- Symptomatology of intestinal occlusion-subocclusion.

- Refractoriness to conventional medical treatment (non-response to the standard 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.

- > 2 stenosis.

- Severe coagulation disorders (platelets < 50,000; INR > 1.5).

^aDe novo stenoses are understood to be those stenoses not located in a surgical anastomosis. “Predominantly fibrotic stenoses” are understood to be those that do not present large ulcers at endoscopy (subscore SES-CD < 3) and that show minimal or no contrast uptake on MR enterography. In cases of stenosis with evident endoscopic and/or radiological activity, immunosuppressants and biologicals must have been previously used (see Inclusion criteria)