Surgery Versus Biologics for Stricturing CD--a RCT
Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial
Zhu Weiming
138 participants
Jun 9, 2022
INTERVENTIONAL
Conditions
Summary
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
Eligibility
Inclusion Criteria6
- with intestinal obstructive symptoms;
- confirmed intestinal strictures;
- traditional drugs failed to induce remission;
- envidence of active bowel inflammation;
- inappropriate for EBD;
- acquirement of written informed consent of participant;
Exclusion Criteria11
- unsuccessful medical treatment of intestinal obstruction;
- complete obstruction;
- contraindication for biologics;
- penetrating disease;
- short smaal bowel;
- suspicion of bowel tumor;
- no confirmed strictures;
- comitant severe disese of other system;
- obstructive symptoms under over 2 targets of biologics;
- successful treatment with traditional drugs;
- participate other clinical research.
Interventions
treat participants with biologics
treat participants with surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05421455