Surgery vs Biologics for Treating Stricturing CD--a RCT
Recruiting · NCT05421455 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhu Weiming
View the official record on ClinicalTrials.gov →Interventions studied
Group AGroup B
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing University - Nanjing, Jiangsu, China