Upper Gastrointestinal Lesions in Crohn's Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease; Upper Gastrointestinal Lesions
• Intervention / Treatment: Other: gastroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: adult patients with Crohn's disease; All adult patients(18 years old or older) with Crohn's disease underwent gastroscopy; patients with diagnosed and treated Crohn's disease had gastroscopy performed during the re-examination, and patients diagnosed with Crohn's disease for the first time had gastroscopy performed during the initial consultation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of different upper gastrointestinal lesions	The incidence of different characteristic lesions of upper gastrointestinal in CD patients.	1 year

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 30, 2018
• Study Completion (Anticipated): May 30, 2018

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2017ZSLYEC-097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No