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NCT Number: NCT05421455

Surgery vs Biologics for Treating Stricturing CD--a RCT

The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.

Recruiting

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location status: Recruiting

Location contact

Weiming Zhu, PhD

CONTACT

[email protected]

86-25-80863736

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with intestinal obstructive symptoms;
  • confirmed intestinal strictures;
  • traditional drugs failed to induce remission;
  • envidence of active bowel inflammation;
  • inappropriate for EBD;
  • acquirement of written informed consent of participant;

Exclusion criteria

  • unsuccessful medical treatment of intestinal obstruction;
  • complete obstruction;
  • contraindication for biologics;
  • penetrating disease;
  • short smaal bowel;
  • suspicion of bowel tumor;
  • no confirmed strictures;
  • comitant severe disese of other system;
  • obstructive symptoms under over 2 targets of biologics;
  • successful treatment with traditional drugs;
  • participate other clinical research.

Treatment and study plan

Group A

Drug

treat participants with biologics

Group B

Procedure

treat participants with surgery

Primary outcomes

  1. clinical remmision rate within 1 year

    Time frame: within 1 year

    Crohn's disease activity index < 150

Secondary outcomes

  1. inflammatory bowel disease score

    Time frame: within 1 and 5 year

    32-224；the higher the better

  2. Crohn's disease obstructive score

    Time frame: within 1 and 5 year

    0-6； the higher the worse

  3. endoscopic recurrence

    Time frame: within 1 and 5 year

    Rutgeert score >i2b (i0-i4); the higher the worse

  4. medical cost

    Time frame: within 1 and 5 year

    cost for hospitalization

  5. sugical recurrence

    Time frame: within 1 and 5 year

    disease recurrence that needs surgical resection

  6. clinical remmision rate within 5 year

    Time frame: within 5 year

    CDAI>150

Study contacts

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

Weinming Zhu, Ph.D.

CONTACT

[email protected]

+86025-80860036

Sponsors and collaborators

Lead sponsor

Zhu Weiming

Other

Registry information

Official study title

Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Jun 16, 2022
Registry last updated
Jul 9, 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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