Upper Gastrointestinal Lesions in Crohn's Disease

NCT03524144 | Unknown

• 1 other identifier: 2017ZSLYEC-097
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Gastrointestinal Lesions; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• the incidence of different upper gastrointestinal lesions

  The incidence of different characteristic lesions of upper gastrointestinal in CD patients.

  1 year

Study Arms (1)

adult patients with Crohn's disease

OTHER

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

Interventions

gastroscopy OTHER

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.

adult patients with Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is 18 years old or older
• patients with diagnosis of Crohn's disease

You may not qualify if:

• diagnostic data were incomplete
• patients with malignant tumor
• use of PPIs or non-steroidal anti-inflammatory drugs in the preceding 4 weeks

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Xiang Gao

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 14, 2018
• Study Start: June 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CN (1)