Crohn's disease
Conditions
Interventions
ustekinumab+exclusive enteral nutrition:one dose of ustekinumab and 4 weeks of exclusive enteral nutrition
exclusive enteral nutrition:4 weeks of exclusive enteral nutrition
Sponsors
General Hospital of Eastern Millitary Command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-75; (2) The activity status score of patients of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0-1 or the Karnofsky score >= 80 points; (3) Diagnosed with CD by endoscopy, pathological biopsy, CTE, MRE, etc; (4) The lesion sites of Montreal CD classification are L1, L2, and L3; (5) Montreal CD subtype disease behavior B3 (penetrating lesions); (6) CTE/MRE confirmed the presence of extraintestinal/internal fistula and abdominal abscess, with a diameter of = 3cm. Percutaneous puncture drainage was performed for abdominal abscess; (7) Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form. They are willing and able to comply with the visit, study plan, laboratory tests, and other research procedures outlined in the study plan; (8) Women of childbearing age must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and agree to use reliable and effective contraception methods during the trial period and for 5 months after the last dose. For male participants whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception during the trial period and within 5 months after the last dose; (9) Patients able to tolerate exclusive enteral nutrition.
Exclusion criteria
Exclusion criteria: (1) Patients with abdominal abscess with a maximum diameter of >= 3cm and unable to undergo percutaneous puncture drainage. (2) Received treatment with other biologics (infliximab, adalimumab, vedolizumab, JAK inhibitors, etc.) within the 4 weeks of enrollment; (3) Patients with acute intestinal obstruction, intestinal perforation, and massive bleeding requiring emergency surgery; Intestinal obstruction cannot tolerate full enteral nutrition and requires intravenous fluid replacement or parenteral nutrition support; (4) Within the past 2 years, have suffered from other active autoimmune diseases that require systemic treatment (i.e. immunomodulatory drugs, corticosteroids, or immunosuppressive drugs); However, alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) will not be considered systemic therapy and are allowed to be used; Suffering from malignant tumors within the first 5 years of enrollment (excluding cured cervical carcinoma in situ, basal or squamous cell carcinoma, localized prostate cancer treated with radical therapy, and ductal carcinoma in situ treated with radical therapy); (5) Prior to randomization, there were active infections (excluding viral hepatitis) that required systematic treatment (oral or intravenous administration); (6) Active tuberculosis patients, or those who have received anti tuberculosis treatment within the previous year prior to randomization; (7) If hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive, the patient's HBV DNA must be less than 500IU/mL; For patients with active hepatitis B, the patient is required to have received antiviral treatment for at least 14 days before randomization (according to local standards, such as entecavir or tenofovir), and agree to continue to receive effective antiviral treatment during the study period before being included in the group; (8) If HCV antibody is positive, HCV-RNA testing should be performed. If HCV-RNA>1000 copy number/mL, the patients should be excluded; (9) Positive for human immunodeficiency virus HIV antibody; (10) Vaccination with any live vaccine (such as vaccines for infectious diseases such as influenza, chickenpox, etc.) within 28 days prior to enrollment; (11) Previously received allogeneic bone marrow transplantation or solid organ transplantation; (12) Previous history of severe allergies to monoclonal antibodies or other biological agents; (13) Participated in other interventional clinical studies within 28 days prior to enrollment; (14) Breastfeeding women cannot be included in the group; (15) Researchers determine the existence of clinically significant underlying medical conditions that may affect the administration of the study drug or adherence to the protocol; (16) Underwent a second surgery within the past 90 days due to postoperative complications; (17) Other individuals deemed unsuitable for the study group by the researchers; (18) Refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgical site infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| clavien-dindo complication classification;comprehensive complication index;recurrence rate; | — |
Countries
China
Contacts
Public ContactGong Jianfeng
General Hospital of Eastern Millitary Command
Outcome results
None listed