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Upper Gastrointestinal Lesions in Crohn's Disease

Primary Purpose

Upper Gastrointestinal Lesions, Crohn's Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
gastroscopy
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Upper Gastrointestinal Lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Sixth Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

adult patients with Crohn's disease

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2018
Last Updated
May 11, 2018
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03524144
Brief Title
Upper Gastrointestinal Lesions in Crohn's Disease
Official Title
Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Anticipated)
Study Completion Date
May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Lesions, Crohn's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
adult patients with Crohn's disease
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
gastroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of different upper gastrointestinal lesions
Description
The incidence of different characteristic lesions of upper gastrointestinal in CD patients.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Gao
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China

12. IPD Sharing Statement

Learn more about this trial

Upper Gastrointestinal Lesions in Crohn's Disease

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