Back to resultsSurgery Versus Biologics for Stricturing CD--a RCT (SIBTC)
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
- with intestinal obstructive symptoms;
- confirmed intestinal strictures;
- traditional drugs failed to induce remission;
- envidence of active bowel inflammation;
- inappropriate for EBD;
- acquirement of written informed consent of participant;
Exclusion Criteria:
- unsuccessful medical treatment of intestinal obstruction;
- complete obstruction;
- contraindication for biologics;
- penetrating disease;
- short smaal bowel;
- suspicion of bowel tumor;
- no confirmed strictures;
- comitant severe disese of other system;
- obstructive symptoms under over 2 targets of biologics;
- successful treatment with traditional drugs;
- participate other clinical research.
Sites / Locations
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Biologic group
Surgery group
Arm Description
treat paticipants with up to 2 biologics
treat paticipants with surgery
Outcomes
Primary Outcome Measures
clinical remmision rate within 1 year
Crohn's disease activity index < 150
Secondary Outcome Measures
inflammatory bowel disease score
32-224；the higher the better
Crohn's disease obstructive score
0-6； the higher the worse
endoscopic recurrence
Rutgeert score >i2b (i0-i4); the higher the worse
medical cost
cost for hospitalization
sugical recurrence
disease recurrence that needs surgical resection
clinical remmision rate within 5 year
CDAI>150
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05421455
Brief Title
Surgery Versus Biologics for Stricturing CD--a RCT
Acronym
SIBTC
Official Title
Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
June 9, 2025 (Anticipated)
Study Completion Date
June 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Weiming
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biologic group
Arm Type
Other
Arm Description
treat paticipants with up to 2 biologics
Arm Title
Surgery group
Arm Type
Other
Arm Description
treat paticipants with surgery
Intervention Type
Drug
Intervention Name(s)
Group A
Intervention Description
treat participants with biologics
Intervention Type
Procedure
Intervention Name(s)
Group B
Intervention Description
treat participants with surgery
Primary Outcome Measure Information:
Title
clinical remmision rate within 1 year
Description
Crohn's disease activity index < 150
Time Frame
within 1 year
Secondary Outcome Measure Information:
Title
inflammatory bowel disease score
Description
32-224；the higher the better
Time Frame
within 1 and 5 year
Title
Crohn's disease obstructive score
Description
0-6； the higher the worse
Time Frame
within 1 and 5 year
Title
endoscopic recurrence
Description
Rutgeert score >i2b (i0-i4); the higher the worse
Time Frame
within 1 and 5 year
Title
medical cost
Description
cost for hospitalization
Time Frame
within 1 and 5 year
Title
sugical recurrence
Description
disease recurrence that needs surgical resection
Time Frame
within 1 and 5 year
Title
clinical remmision rate within 5 year
Description
CDAI>150
Time Frame
within 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
with intestinal obstructive symptoms;
confirmed intestinal strictures;
traditional drugs failed to induce remission;
envidence of active bowel inflammation;
inappropriate for EBD;
acquirement of written informed consent of participant;
Exclusion Criteria:
unsuccessful medical treatment of intestinal obstruction;
complete obstruction;
contraindication for biologics;
penetrating disease;
short smaal bowel;
suspicion of bowel tumor;
no confirmed strictures;
comitant severe disese of other system;
obstructive symptoms under over 2 targets of biologics;
successful treatment with traditional drugs;
participate other clinical research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weinming Zhu, Ph.D.
Phone
+86025-80860036
Email
juwiming@nju.edu.cn
Facility Information:
Facility Name
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiming Zhu, PhD
Phone
86-25-80863736
Email
juwiming@nju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgery Versus Biologics for Stricturing CD--a RCT
We'll reach out to this number within 24 hrs