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Acute Upper Gastrointestinal Non Variceal HemorrhageNCT04895904

Endoscopic Diagnosis and Treatment of Acute Nonvariceal Upper Gastrointestinal Bleeding

An observational study of Acute Upper Gastrointestinal Non Variceal Hemorrhage, run by The First Affiliated Hospital of Nanchang University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 85 years
How many people
3,200 participants
Where
No sites listed yet
Study dates
1 Sep 2014to 28 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Being tested
No intervention
Keywords
Acute upper gastrointestinal non variceal hemorrhage, peptic ulcer, Dieulafoy's lesion, Gastric ulcer bleeding, Endoscopic hemostasis
Medical subject headings
Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days after endoscopic hemostasis

Secondary outcomes (2)

  1. surgery due to rebleeding

    Surgical treatment for rebleeding

    Measured: Within 30 days after endoscopic hemostasis

  2. Mortality

    Mortality due to rebleeding

    Measured: Within 30 days after endoscopic hemostasis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start1 Sep 2014
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895904
Sponsor's protocol ID
2021058
Status last verified
May 2021
First submitted
19 May 2021
Last updated
20 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There is no plan to make it public. Please contact me if you need

Publications

  • 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.

    PubMed 22688850

  • 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.

    PubMed 23732464

  • 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.

    PubMed 31634917

  • 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.

    PubMed 29671413

  • 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.

    PubMed 31785733

  • 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.

    PubMed 35164682

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Upper Gastrointestinal Non Variceal Hemorrhage, run by The First Affiliated Hospital of Nanchang University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rebleeding (time frame: Within 30 days after endoscopic hemostasis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895904, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.

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