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Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis | Clinical Trials | Clareo Health

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Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis

NCT07409376•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 16 and 75 years.
•2. Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.
•3. Inadequate response to conventional medical therapy and step-up treatment strategies.
•4. Stricture length less than 5 cm.
•5. Signed informed consent form.

Exclusion Criteria

•1. Bowel wall thickening with Limberg grade IV blood flow on intestinal ultrasound, or presence of complications such as perforation, fistula, deep ulcer, inflammatory mass, or abscess.
•2. Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
•3. Presence of strictures in the esophagus, stomach, or duodenum.
•4. Presence of colorectal stricture or ileocecal valve stricture.
•5. Small bowel stricture complicated by abscess, fistula, or severe angulation.
•6. Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
•7. Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
•8. Pregnancy or breastfeeding.
•9. Inability to undergo endoscopic treatment.
•10. Severe coagulation disorders (platelet count \<70,000/μL, INR \>1.5).
+2 more criteria

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

February 13, 2026

Enrollment

100

ESTIMATED participants

Conditions

CD - Crohn's Disease

Interventions

stricture incision

PROCEDURE

balloon dilation

PROCEDURE

No Interventions

PROCEDURE

Contacts

Shenglong Xia, Phd

CONTACT

+86-19857128950 xsl89@zju.edu.cn

Surong Hu, PhD

CONTACT

+86-15868532956 526315332@qq.com

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

NCT07385131

Inflammatory Bowel Disease (IBD)CD - Crohn's Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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