Surgery Versus Biologics for Stricturing CD--a RCT

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Drug: Group A; Procedure: Group B

• Registration Number: NCT05421455
• Lead Sponsor: Zhu Weiming

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-09
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-12
• Study First Posted: 2022-06-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-13
• Primary Completion: 2025-06-09
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biologic group	Group A	treat paticipants with up to 2 biologics
Surgery group	Group B	treat paticipants with surgery

Primary Outcome Measures

Name	Time	Method
clinical remmision rate within 1 year	within 1 year	Crohn's disease activity index \< 150

Secondary Outcome Measures

Name	Time	Method
clinical remmision rate within 5 year	within 5 year	CDAI\>150
sugical recurrence	within 1 and 5 year	disease recurrence that needs surgical resection
inflammatory bowel disease score	within 1 and 5 year	32-224；the higher the better
Crohn's disease obstructive score	within 1 and 5 year	0-6； the higher the worse
endoscopic recurrence	within 1 and 5 year	Rutgeert score \>i2b (i0-i4); the higher the worse
medical cost	within 1 and 5 year	cost for hospitalization

Trial Locations

Locations (1)

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China