Endoscopic Diagnosis and Treatment of Acute Nonvariceal Upper Gastrointestinal Bleeding

Sponsor

The First Affiliated Hospital of Nanchang University (Other)

Overall Status

Completed

CT.gov ID

NCT04895904

Collaborator

(none)

3,200

Enrollment

77.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Upper Gastrointestinal Non Variceal Hemorrhage	Other: No intervention

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 Design

Study Type:

Observational

Actual Enrollment :

3200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Outcome Measures

Primary Outcome Measures

Rebleeding [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.

Secondary Outcome Measures

surgery due to rebleeding [Within 30 days after endoscopic hemostasis]
Surgical treatment for rebleeding
Mortality [Within 30 days after endoscopic hemostasis]
Mortality due to rebleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.