Endoscopic Diagnosis and Treatment of Acute Nonvariceal Upper Gastrointestinal Bleeding

NCT04895904 | Completed

• 1 other identifier: 2021058
• Study Type: observational
• Target: 3,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Upper Gastrointestinal Non Variceal Hemorrhage

Keywords

Acute upper gastrointestinal non variceal hemorrhage; peptic ulcer; Dieulafoy's lesion; Gastric ulcer bleeding; Endoscopic hemostasis

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  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 Outcomes (2)

• surgery due to rebleeding

  Within 30 days after endoscopic hemostasis

• Mortality

  Within 30 days after endoscopic hemostasis

Interventions

No intervention OTHER

Our study is an observational study and the main purpose of our study is to observe the efficacy of endoscopic hemostasis and drug therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Related Publications (6)

• Laine L, Yang H, Chang SC, Datto C. Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009. Am J Gastroenterol. 2012 Aug;107(8):1190-5; quiz 1196. doi: 10.1038/ajg.2012.168. Epub 2012 Jun 12.

  PMID: 22688850 RESULT

• Rosenstock SJ, Moller MH, Larsson H, Johnsen SP, Madsen AH, Bendix J, Adamsen S, Jensen AG, Zimmermann-Nielsen E, Nielsen AS, Kallehave F, Oxholm D, Skarbye M, Jolving LR, Jorgensen HS, Schaffalitzky de Muckadell OB, Thomsen RW. Improving quality of care in peptic ulcer bleeding: nationwide cohort study of 13,498 consecutive patients in the Danish Clinical Register of Emergency Surgery. Am J Gastroenterol. 2013 Sep;108(9):1449-57. doi: 10.1038/ajg.2013.162. Epub 2013 Jun 4.

  PMID: 23732464 RESULT

• Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.

  PMID: 31634917 RESULT

• Lanas A, Dumonceau JM, Hunt RH, Fujishiro M, Scheiman JM, Gralnek IM, Campbell HE, Rostom A, Villanueva C, Sung JJY. Non-variceal upper gastrointestinal bleeding. Nat Rev Dis Primers. 2018 Apr 19;4:18020. doi: 10.1038/nrdp.2018.20.

  PMID: 29671413 RESULT

• Canamares-Orbis P, Chan FKL. Endoscopic management of nonvariceal upper gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019 Oct-Dec;42-43:101608. doi: 10.1016/j.bpg.2019.04.001. Epub 2019 Apr 17.

  PMID: 31785733 RESULT

• Lai Y, Xu Y, Zhu Z, Pan X, Long S, Liao W, Li B, Zhu Y, Chen Y, Shu X. Development and validation of a model to predict rebleeding within three days after endoscopic hemostasis for high-risk peptic ulcer bleeding. BMC Gastroenterol. 2022 Feb 14;22(1):64. doi: 10.1186/s12876-022-02145-9.

  PMID: 35164682 DERIVED

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 20, 2021
• Study Start: September 1, 2014
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05