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Search / Trial NCT01555437

Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Mar 14, 2012

Trial Information

Current as of May 29, 2025

Completed

Keywords

Capsule Endoscopy Scoring Index Harvey Bradshaw Index C Reactive Protein Serum Albumin Hemoglobin

ClinConnect Summary

Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of \<135. Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.

HBI HBI was used to assess the clinical disease activity. Patients with HBI \>4 were considered to have clinically active disease.\[7\]

Blood analysis At the time of CE, patients provided a blood sample for measurement of hemog...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients with known SBCD or newly diagnosed SBCD
  • those patients for whom complete CE examination (in which the capsule
  • reached the cecum within the CE test time) was achieved were retained for study
  • Exclusion Criteria:
  • incomplete CE examination
  • infectious enterocolitis
  • symptoms related to perianal penetrating disease
  • gastrointestinal cancer
  • ulcerative colitis
  • indeterminate colitis
  • history of extensive small bowel resection
  • known CD of the upper gastrointestinal tract or colon
  • intake of non-steroidal anti-inflammatory drugs (NSAIDs) (more than two tablets per week)
  • pregnancy

About Shanghai Jiao Tong University School Of Medicine

Shanghai Jiao Tong University School of Medicine is a leading academic institution in China, renowned for its commitment to advancing medical research and education. As a prominent clinical trial sponsor, the school leverages its extensive expertise in biomedical sciences and innovative healthcare solutions to conduct rigorous clinical studies aimed at improving patient outcomes. With a focus on collaboration and translational research, the institution fosters partnerships with healthcare providers, industry leaders, and regulatory bodies to ensure the highest standards of scientific integrity and ethical conduct in clinical trials. Through its research initiatives, Shanghai Jiao Tong University School of Medicine strives to contribute significantly to the global medical community and enhance the quality of healthcare delivery.

Locations

Patients applied

0 patients applied

Trial Officials

Zhizheng Ge, MD. Ph.D

Principal Investigator

RenJi Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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