Surgery vs Biologics for Treating Stricturing CD--a RCT (SIBTC)

Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Group A; Procedure: Group B

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weinming Zhu, Ph.D.; Phone Number: +86025-80860036; Email: juwiming@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
      • Contact: Weiming Zhu, PhD; Phone Number: 86-25-80863736; Email: juwiming@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biologic group; If biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence	Drug: Group A; treat participants with biologics
Other: Surgery group; treat paticipants with surgery and prophylactic medication according to the guidelines	Procedure: Group B; treat participants with surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical remmision rate within 1 year	Crohn's disease activity index < 150	within 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhu Weiming

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: jinlingH20220609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No