NCT03513900

Brief Summary

Portal hypertensive gastropathy (PHG) is used to describe the endoscopic appearance of gastric mucosa in patients with cirrhotic portal hypertension, with a characteristic mosaic-like pattern with or without red spots. The severity of PHG can vary from mild to severe, and patients with PHG are at an increased risk of acute and chronic gastrointestinal bleeding. According to the study by Kim et al, severe PHG showed a significantly high-risk of mortality and reduced expected survival time than none or mild PHG. Therefore, we need to detect PHG as soon as possible.However, as an invasive examination, endoscopy examination may massive gastrointestinal bleeding or gastric perforation. Most patients are afraid and disable to tolerate it, which significantly reduces the real morbidity of PHG and delays the time for diagnosis and treatment. Therefore, there is a need to find effective non-invasive methods that can predict patients with PHG in the early stage, especially which require treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

March 29, 2018

Last Update Submit

June 10, 2019

Conditions

Cirrhosis

Keywords

Non-invasive methodsCirrhosisPotal hypertensive gastropathyDiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • PHG and EVs detected by endoscopy

    All patients will undergo or have been undergone endoscopy, endoscopy is performed by a small number of experienced endoscopy operators.The severity of PHG and the presence of EVS will be recorded.

    3 months

Study Arms (1)

cirrhosis

In this cross-sectional study , we will collect all patients with cirrhosis who meet the inclusion and exclusion criteria criteria coming to The Second Affiliated Hospital, Xi'an Jiaotong University since March 2018 to December 2018.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this cross-sectional study , we will collect all patients with cirrhosis who meet the inclusion and exclusion criteria criteria coming to The Second Affiliated Hospital, Xi'an Jiaotong University since March 2018 to December 2018 .

You may qualify if:

  • aged 18-80 years old.
  • confirmed patients with cirrhosis : Cirrhosis is diagnosed using standard laboratory, radiological, and physical examination findings, or by liver histology in equivocal cases
  • paired noninvasive tests (blood tests, TE, and CT/enhanced CT) and gastroscopy within 3 months;
  • The nature of the present study was explained to all patients and informed consent was obtained from each case.

You may not qualify if:

  • the presence of severe ascites that might significantly hamper the accurate assessment of LSM , obesity (body mass index\>35kg/m2) or intercostal space was too narrow;
  • severe cardiopulmonary diseases, renal failure, acute illness, infectious diseases, acute liver failure or cholestasis or hepatic congestion;
  • malignant tumors or other serious medical diseases (such as hepatocellular carcinoma, gastric cancer, pancreatic cancer and colon cancer) that may reduce expected survival time;
  • non-cirrhotic portal hypertension and those with portal vein thrombosis;
  • previous or ongoing treatment for portal hypertension, spleen diameter\<4cm or splenectomy;
  • pregnant women and patients with implanted pacemakers;
  • patients can not cooperate with the endoscopy, CT/enhanced CT, FibroTouch /FibroScan and other related examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jinhai Wang, MD

    The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shaanxi, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

May 2, 2018

Study Start

March 6, 2018

Primary Completion

December 20, 2018

Study Completion

April 20, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)