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NCT03524144 Clinical Trial

Upper Gastrointestinal Lesions in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03524144
Other study ID # 2017ZSLYEC-097
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date May 30, 2018

Study information
Verified date May 2018
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun Yat-sen University were recruited. All patients underwent upper gastrointestinal endoscopy and biopsy by two defined endoscopists and two pathologists, the basic information were collected at the same time, in order to assess the prevalence of upper gastrointestinal involvement, and determine the role of upper gastrointestinal endoscopy in adult Crohn's disease patients, irrespective of upper gastrointestinal symptoms.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 160
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age is 18 years old or older

- patients with diagnosis of Crohn's disease

Exclusion Criteria:

- diagnostic data were incomplete

- patients with malignant tumor

- use of PPIs or non-steroidal anti-inflammatory drugs in the preceding 4 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• gastroscopy
Two endoscopists performed upper gastrointestinal endoscopy and biopsy on all patients; and histological review was performed by two pathologists. From each patient, 10 specimens were taken from 6 areas in the upper gastrointestinal tract and basic informations was collected.

Locations
Country Name City State
China The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of different upper gastrointestinal lesions The incidence of different characteristic lesions of upper gastrointestinal in CD patients. 1 year
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