Surgery Versus Biologics for Stricturing CD--a RCT

Crohn Disease Clinical Trial

— SIBTC  

Official title:

Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421455
• Other study ID #: jinlingH20220609
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: June 2030

Study information

• Verified date: July 2022
• Source: Jinling Hospital, China
• Contact: Weinming Zhu, Ph.D.
• Phone: +86025-80860036
• Email: juwiming[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: June 2030
• Est. primary completion date: June 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Group A
treat participants with biologics

Procedure:
• Group B
treat participants with surgery

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Weiming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical remmision rate within 1 year	Crohn's disease activity index < 150	within 1 year
Secondary	inflammatory bowel disease score	32-224;the higher the better	within 1 and 5 year
Secondary	Crohn's disease obstructive score	0-6; the higher the worse	within 1 and 5 year
Secondary	endoscopic recurrence	Rutgeert score >i2b (i0-i4); the higher the worse	within 1 and 5 year
Secondary	medical cost	cost for hospitalization	within 1 and 5 year
Secondary	sugical recurrence	disease recurrence that needs surgical resection	within 1 and 5 year
Secondary	clinical remmision rate within 5 year	CDAI>150	within 5 year