Status:
RECRUITING
Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Sixth Affiliated Hospital, Sun Yat-sen University
Second Affiliated Hospital of Soochow University
Conditions:
Crohn Disease
Stricture; Bowel
Eligibility:
All Genders
18-65 years
Brief Summary
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the di...
Detailed Description
This study intends to select patients with confirmed moderate-to-severe CD and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself throu...
Eligibility Criteria
Inclusion
- Clinical diagnosis of moderate to severe Crohn's disease
- Obstructive symptoms within the last eight weeks
- A single or several lumen stricture(s) identified by radiological imaging or endoscopy
- For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm
- For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing
Exclusion
- Requirement of urgent surgery or endoscopic intervention within 2 months as judged by the clinician
- Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions
- Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture
- Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc.
- Unable to eat after using enteral nutrition for more than 2 months
- History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months
- CT enterograph contraindications, such as allergy to contrast media
- Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease
- Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy
- Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors
- Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome
- Combination of severe liver and kidney dysfunction
- Coexistence of bacterial or viral active infection
- Pregnant or breastfeeding
- Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT05387031
Start Date
August 1 2024
End Date
August 1 2027
Last Update
August 1 2024
Active Locations (8)
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1
Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital
Beijing, Beijing Municipality, China
2
Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences
Chongqing, Chongqing Municipality, China
3
Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
4
Department of Gastroenterology, Huai'an First People's Hospital
Huai'an, Jiangsu, China