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

Z

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)

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

Trial contacts and locations

1

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Central trial contact

Weinming Zhu, Ph.D.

Data sourced from clinicaltrials.gov

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