Surgery Versus Biologics for Stricturing CD--a RCT (SIBTC)

Zhu Weiming

Status: Enrolling

Conditions: Crohn Disease

Treatments: Procedure: Group B; Drug: Group A

Study type: Interventional

Funder types: Other

Identifiers

NCT05421455

jinlingH20220609

Details and patient eligibility

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. with intestinal obstructive symptoms;
2. confirmed intestinal strictures;
3. traditional drugs failed to induce remission;
4. envidence of active bowel inflammation;
5. inappropriate for EBD;
6. acquirement of written informed consent of participant;

Exclusion criteria

1. unsuccessful medical treatment of intestinal obstruction;
2. complete obstruction;
3. contraindication for biologics;
4. penetrating disease;
5. short smaal bowel;
6. suspicion of bowel tumor;
7. no confirmed strictures;
8. comitant severe disese of other system;
9. obstructive symptoms under over 2 targets of biologics;
10. successful treatment with traditional drugs;
11. participate other clinical research.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Biologic group

Other group

Description:

treat paticipants with up to 2 biologics

Treatment:

Drug: Group A

Surgery group

Other group

Description:

treat paticipants with surgery

Treatment:

Procedure: Group B