Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.

Xiang Gao184 enrolled

Overview

Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission in Crohn Disease(CD). Currently, it is believed that the use of UST for the preoperative treatment of CD patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of CD. However, there is still a lack of literature reporting the role of UST in preoperative optimization for CD. Semi-enteral nutrition refers to the provision of more than 50% of the energy required by the human body through enteral nutrition preparations. Semi-enteral nutrition can improve the nutritional status of patients with CD, but it does not induce remission of active disease. The treatment method of UST combined with semi-enteral nutrition can not only induce disease remission, but also improve the nutritional status of patients. Therefore, can the combined treatment regimen replace Exclusive Enteral nutrition (EEN) as a new therapy for preoperative optimization of CD? At present, there is a lack of relevant research, so this study intends to conduct a multi-center, prospective, randomized controlled trial to compare the efficacy differences between UST+semi-enteral nutrition and EEN in preoperative optimization for CD, and to clarify the preoperative optimization effect of UST combined with semi-enteral nutrition therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Crohn Disease (CD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis; * CD patients diagnosed prior to surgery; * Patients aged 18-65; * CDAI score of \>150; * For patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study; * The patients agree to participate in the study and sign an informed consent form; * Patients who have not used ustekinumab prior to surgery; * Patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery. Exclusion Criteria: * Emergency surgery; * Had received exclusive enteral nutrition support within 3 months prior to surgery; * Unable to tolerate enteral nutrition; * Failed with UST; * Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.

Outcomes

Primary Outcomes

Preoperative clinical remission rate

Patients enrolled should collect basic information such as height, weight, disease activity at baseline, and complete examinations including complete blood count, blood biochemistry (electrolytes, liver and kidney function), C-reactive protein, CTE/MRE, intestinal color Doppler ultrasound, nutritional risk NRS2002 score, colonoscopy, as well as iron, calcium, folic acid, and other trace elements. These indicators should be rechecked after 6 weeks post-enrollment.Compare the clinical remission rates of two groups of patients after treatment.

Time frame: From enrollment to the end of treatment at 6 weeks

Secondary Outcomes

Incidence of complications within 30 days post-surgery

Postoperative day 3: Complete the QoR-15 questionnaire; Postoperative day 7: Re-examine blood routine, liver and kidney function, CRP, and intestinal color Doppler ultrasound; Postoperative week 4: Re-examine blood routine, liver and kidney function, CRP, intestinal color Doppler ultrasound, and complete the IBDQ questionnaire.

Time frame: Within 30 days post-surgery

Changes in nutritional and inflammatory indicators before and after optimization

Compare the baseline and the height, weight, and inflammatory indicators (including complete blood count, CRP, liver function, etc.) of two groups of patients after 6 weeks of treatment.

Time frame: From enrollment to the end of treatment at 6 weeks

Surgical anastomosis rate for phase I

Compare the anastomosis rate after the first stage of surgery between two groups of optimized patients.

Time frame: From enrollment to the end of surgery

Clinical recurrence rate at 12 weeks post-operation

Clinical relapse: Patients in clinical remission who, at any visit, have a Crohn's Disease Activity Index (CDAI) of 150 or higher.

Time frame: Within 12 weeks post-surgery

Histological status of surgical margins

Comparing the histological conditions of surgical margins in patients after optimization treatment between two groups, to verify whether UST + semi-enteral nutrition has a better therapeutic effect.