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NCT Number: NCT07409376

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
  • Presence of strictures in the esophagus, stomach, or duodenum.
  • Presence of colorectal stricture or ileocecal valve stricture.
  • Small bowel stricture complicated by abscess, fistula, or severe angulation.
  • Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
  • Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
  • Pregnancy or breastfeeding.
  • Inability to undergo endoscopic treatment.
  • Severe coagulation disorders (platelet count <70,000/μL, INR >1.5).
  • Concomitant advanced tumors or other severe organ diseases.
  • Suspected localized intestinal malignancy.

Treatment and study plan

stricture incision

Procedure

Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation

balloon dilation

Procedure

Balloon-assisted enteroscopy-guided balloon dilation

No Interventions

Procedure

No Intervention

Primary outcomes

  1. Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up

    Time frame: 1 year

    Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure.

Secondary outcomes

  1. Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up

    Time frame: 3 years

    Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure.

  2. Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up

    Time frame: 5 years

    Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure.

  3. Safety assessment of the two treatment methods

    Time frame: Within 2 months post-procedure

    Evaluation of procedure-related complications, including postoperative bleeding, perforation, and any adverse events (AEs) or serious adverse events (SAEs) occurring within 2 months after the procedure.

  4. Immediate technical success of the procedure

    Time frame: At the time of procedure

    Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision.

  5. Symptom-free duration within 1 year post-procedure

    Time frame: 1 year

    Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale.

  6. Cost analysis of the two treatment methods

    Time frame: Up to 1 year post-procedure

    Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses.

Study contacts

Contact information is provided by the study sponsor or research team.

Shenglong Xia, Phd

CONTACT

[email protected]

+86-19857128950

Surong Hu, PhD

CONTACT

[email protected]

+86-15868532956

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Acronym: CD stenosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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