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Upper Gastrointestinal Lesions in Crohn's Disease

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03524144
Collaborator
(none)
160
Enrollment
1
Location
1
Arm
11.9
Anticipated Duration (Months)
13.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: gastroscopy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
May 30, 2018
Anticipated Study Completion Date :
May 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the incidence of different upper gastrointestinal lesions [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China 510655

Sponsors and Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Gao, Clinical Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03524144
Other Study ID Numbers:
  • 2017ZSLYEC-097
First Posted:
May 14, 2018
Last Update Posted:
May 14, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Crohn Disease

Study Results

No Results Posted as of May 14, 2018