RecruitingNot ApplicableNCT05421455

Surgery Versus Biologics for Stricturing CD--a RCT

Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial


Sponsor

Zhu Weiming

Enrollment

138 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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.

Interventions

DRUGGroup A

treat participants with biologics

PROCEDUREGroup B

treat participants with surgery


Locations(1)

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

Nanjing, Jiangsu, China

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NCT05421455


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