Endoscopic Diagnosis and Treatment of Acute Nonvariceal Upper Gastrointestinal Bleeding

May 19, 2021 updated by: Xu Shu, The First Affiliated Hospital of Nanchang University

Endoscopic Diagnosis, Treatment and Prognosis of Acute Nonvariceal Upper Gastrointestinal Bleeding in Nanchang, Jiangxi Province, China.

Acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) is a common critical disease in gastroenterology. Due to the development of modern medical technology, the incidence rate of ANVUGIB has been decreasing in recent years, but its mortality within 30 days is still 11%. Endoscopic hemostasis and drug therapy are the first choice for the treatment of ANVUGIB. After endoscopic hemostasis, it is very important to treat peptic ulcer bleeding with strong acid suppression therapy to maintain gastric pH above 6.0. This study is to study the effect of endoscopic and drug treatment of ANVUGIB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) is a common critical disease in gastroenterology. It refers to the bleeding caused by the non varicose diseases above the ligament of flexor, including the bleeding of pancreaticobiliary tract and the bleeding caused by the diseases near the anastomotic stoma after gastrojejunostomy. Due to the development of modern medical technology, the incidence rate of ANVUGIB has been decreasing in recent years. A US study shows that the incidence rate of ANVUGIB dropped from 78/10 to 61/10 10000 [1] from 2001 to 2009. However, the mortality within 30 days of ANVUGIB is still as high as 11% [2]. Peptic ulcer bleeding is the most common cause of bleeding in ANVUGIB. The annual incidence rate is 19.4-57/10 million, and the rate of rebleeding within 7 days is 13.9%, and the mortality rate is 30 in 30 days. A study in China shows that compared with the 1990s, the detection rate of high-risk ulcer has increased, but the overall mortality has not decreased significantly [4]. Endoscopic hemostasis is the first choice for the treatment of peptic ulcer. The latest guidelines of our country recommend that patients with upper gastrointestinal bleeding with stable hemodynamics should try their best to have emergency gastroscopy within 24 hours after bleeding, and emergency endoscopic hemostasis is feasible for bleeding lesions [5]. After endoscopic hemostasis, it is very important to give strong acid suppression therapy to maintain gastric pH above 6.0 in the treatment of peptic ulcer bleeding [6-9]. This study is to analyze the effect of endoscopic and drug treatment of ANVUGIB.

Study Type

Observational

Enrollment (Actual)

3200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The people who come to Nanchang University First Affiliated Hospital for medical treatment

Description

Inclusion Criteria:

  • From January 2014 to February 2021, patients with acute nonvariceal upper gastrointestinal bleeding underwent emergency endoscopic hemostasis in our hospital.

Exclusion Criteria:

  • 1. The age is less than or equal to 18 years old and greater than or equal to 85 years old; 2. Forrest grade IIC and III; 3. Complicated with severe cardiovascular and cerebrovascular diseases or severe liver and kidney diseases (such as heart failure, liver failure, renal failure, etc.); 4. The records of the cases were incomplete.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding
Time Frame: Within 30 days after endoscopic hemostasis

Clinically, the following symptoms or laboratory examination results suggest rebleeding within 30 days after successful endoscopic hemostasis：(1) The frequency of hematemesis or melena increased, the vomit was bright red or dark red bloody stool, or accompanied by active bowel sounds;

(2) After rapid infusion and blood transfusion, the symptoms of peripheral circulation failure did not improve significantly, or although temporarily improved and then deteriorated, the central venous pressure still fluctuated, slightly stable and then decreased;

(3) Red blood cell count, hemoglobin concentration and hematocrit continued to decrease, reticulocyte count continued to increase;

(4) In the case of sufficient fluid replacement and urine volume, blood urea nitrogen continued or increased again.
Within 30 days after endoscopic hemostasis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgery due to rebleeding
Time Frame: Within 30 days after endoscopic hemostasis
Surgical treatment for rebleeding
Within 30 days after endoscopic hemostasis
Mortality
Time Frame: Within 30 days after endoscopic hemostasis
Mortality due to rebleeding
Within 30 days after endoscopic hemostasis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

There is no plan to make it public. Please contact me if you need

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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