SIBTC: Surgery Versus Biologics for Stricturing CD--a RCT

• Sponsor: Zhu Weiming (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05421455
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 95.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Drug: Group A; Procedure: Group B	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial
• Actual Study Start Date: Jun 9, 2022
• Anticipated Primary Completion Date: Jun 9, 2025
• Anticipated Study Completion Date: Jun 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Other: Biologic group treat paticipants with up to 2 biologics	Drug: Group A; treat participants with biologics
Other: Surgery group treat paticipants with surgery	Procedure: Group B; treat participants with surgery

Outcome Measures

Primary Outcome Measures

1. clinical remmision rate within 1 year [within 1 year]

   Crohn's disease activity index < 150

Secondary Outcome Measures

1. inflammatory bowel disease score [within 1 and 5 year]

   32-224；the higher the better

2. Crohn's disease obstructive score [within 1 and 5 year]

   0-6； the higher the worse

3. endoscopic recurrence [within 1 and 5 year]

   Rutgeert score >i2b (i0-i4); the higher the worse

4. medical cost [within 1 and 5 year]

   cost for hospitalization

5. sugical recurrence [within 1 and 5 year]

   disease recurrence that needs surgical resection

6. clinical remmision rate within 5 year [within 5 year]

   CDAI>150

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

• Zhu Weiming

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhu Weiming, chief of general surgery, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT05421455
• Other Study ID Numbers: jinlingH20220609
• First Posted: Jun 16, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Jul 13, 2022