Crohn DiseaseNCT05421455
Surgery vs Biologics for Treating Stricturing CD--a RCT
A study testing Group A and Group B in people with Crohn Disease, run by Zhu Weiming at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Group A and Group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- unsuccessful medical treatment of intestinal obstruction;
- complete obstruction;
- contraindication for biologics;
- penetrating disease;
- short smaal bowel;
- suspicion of bowel tumor;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Weiming Zhu, PhD, 86-25-80863736, juwiming@nju.edu.cn
About this study
Official title: 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.
- Conditions
- Crohn Disease
- Being tested
- Group A, Group B
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADrug
treat participants with biologics
Group BProcedure or surgery
treat participants with surgery
| Study group | Role | What they receive |
|---|---|---|
| Biologic group | Other | 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 Receives: Drug: Group A |
| Surgery group | Other | treat paticipants with surgery and prophylactic medication according to the guidelines Receives: Procedure: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remmision rate within 1 year
Crohn's disease activity index < 150
Measured: within 1 year
Secondary outcomes (6)
inflammatory bowel disease score
32-224；the higher the better
Measured: within 1 and 5 year
Crohn's disease obstructive score
0-6； the higher the worse
Measured: within 1 and 5 year
endoscopic recurrence
Rutgeert score >i2b (i0-i4); the higher the worse
Measured: within 1 and 5 year
medical cost
cost for hospitalization
Measured: within 1 and 5 year
sugical recurrence
disease recurrence that needs surgical resection
Measured: within 1 and 5 year
clinical remmision rate within 5 year
CDAI>150
Measured: within 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start9 Jun 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Weiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421455
- Sponsor's protocol ID
- jinlingH20220609
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05421455
- Acronym / sponsor ID
- jinlingH20220609
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Zhu WeimingUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic group | Other | Drug: Group AIf biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence |
| Surgery group | Other | Procedure: Group Btreat paticipants with surgery and prophylactic medication according to the guidelines |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- with intestinal obstructive symptoms;
- confirmed intestinal strictures;
- traditional drugs failed to induce remission;
- envidence of active bowel inflammation;
- inappropriate for EBD;
Key exclusion criteria (11 listed)
- unsuccessful medical treatment of intestinal obstruction;
- complete obstruction;
- contraindication for biologics;
- penetrating disease;
- short smaal bowel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Atreat participants with biologics | Drug | Biologic group |
| Group Btreat participants with surgery | Procedure or surgery | Surgery group |
Primary outcome
clinical remmision rate within 1 year
Time frame: within 1 year
Crohn's disease activity index < 150
6 secondary outcomes
inflammatory bowel disease score
Time frame: within 1 and 5 year
Crohn's disease obstructive score
Time frame: within 1 and 5 year
endoscopic recurrence
Time frame: within 1 and 5 year
medical cost
Time frame: within 1 and 5 year
sugical recurrence
Time frame: within 1 and 5 year
clinical remmision rate within 5 year
Time frame: within 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Crohn Disease, run by Zhu Weiming at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weinming Zhu, Ph.D. (+86025-80860036, juwiming@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remmision rate within 1 year (time frame: within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.