Factors Predicting the Need for Endoscopic Intervention in Non-variceal Upper Gastrointestinal Bleeding

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05979025
Collaborator
(none)
262
1
12.6
20.8

Study Details

Study Description

Brief Summary

Gastrointestinal system bleedings are medical emergencies and the most common cause of hospital admissions related to digestive system diseases. Gastrointestinal system bleedings are a frequently encountered condition and one of the significant reasons leading to morbidity, mortality, and medical care costs. For acute upper gastrointestinal system bleedings, the annual hospital admission incidence in the United States is approximately 67 per 100,000 adults, making it more common than lower gastrointestinal system bleedings. Approximately 80% of acute upper gastrointestinal system bleedings are attributed to non-variceal causes. Endoscopy is an invasive procedure used for diagnosis and treatment in upper gastrointestinal system bleedings. . In recent years, there has been an increase in endoscopy and endoscopic treatment rates. Except for variceal bleedings, most upper gastrointestinal system bleedings stop without the need for endoscopic intervention. However, some patients require endoscopic intervention and identifying this high-risk group, prone to recurrent bleeding, through non-invasive tests is crucial. In investigators' prospective study, researcher aimed to facilitate the identification of patients who require intervention and undergo endoscopic intervention (e.g., epinephrine injection, hemoclips, thermal coagulation, argon plasma coagulation, etc.) among those who underwent endoscopy within the first 24 hours after admission to the hospital's emergency department with a diagnosis of non-variceal acute upper gastrointestinal system bleeding. Investigators sought to achieve this by determining the relevant parameters related to their clinical and laboratory findings, comorbidities, and demographic characteristics at the time of admission. This approach aims to reduce hospital admissions, hospital stay, and costs, and particularly to minimize interventional procedures during seizures and decrease complications.As of August 2022, patients who applied to the Ankara Bilkent City Hospital emergency department were followed up.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Gastrointestinal system bleedings are medical emergencies and the most common cause of hospital admissions related to digestive system diseases. Gastrointestinal system bleedings are a frequently encountered condition and one of the significant reasons leading to morbidity, mortality, and medical care costs. For acute upper gastrointestinal system bleedings, the annual hospital admission incidence in the United States is approximately 67 per 100,000 adults, making it more common than lower gastrointestinal system bleedings. A decrease in the incidence of non-variceal acute upper gastrointestinal system bleeding has been observed compared to previous years, which is believed to be associated with an increase in the use of proton pump inhibitors (PPIs), eradication of Helicobacter pylori (H. pylori), and advancements in endoscopic treatment. Approximately 80% of acute upper gastrointestinal system bleedings are attributed to non-variceal causes.

    Endoscopy is an invasive procedure used for diagnosis and treatment in upper gastrointestinal system bleedings. In recent years, there has been an increase in endoscopy and endoscopic treatment rates. Previous studies have identified higher mortality rates, around 5-10% for bleeding due to peptic ulcers, and approximately 15% for esophageal variceal bleedings. The development of modern endoscopy has led to significant advancements in various therapeutic techniques. Mortality related to all causes of upper gastrointestinal system bleedings has declined due to advancements in treatment. In recent years, there has been a decrease in hospitalization duration and mortality, but the total economic burden has significantly increased.

    Except for variceal bleedings, most upper gastrointestinal system bleedings stop without the need for endoscopic intervention. However, some patients require endoscopic intervention and identifying this high-risk group, prone to recurrent bleeding, through non-invasive tests is crucial. In cases where endoscopic treatment is insufficient, surgical or interventional radiology procedures such as embolization may be necessary. Endoscopic treatment has led to a reduction in the need for surgery and blood transfusions in patients presenting with upper gastrointestinal system bleeding. The goal of treatment is to prevent complications and deaths. Determining the need for treatment for a patient is clinically and practically easier than predicting who will die or re-bleed.

    Gastrointestinal bleedings can lead to various clinical scenarios due to multiple lesion types, and they can occur from any part of the gastrointestinal system, either overtly or covertly. Upper gastrointestinal bleedings are approximately 5 times more common than lower gastrointestinal bleedings. Several scoring systems, such as Glasgow-Blatchford, Rockall, AIMS65, have been developed to predict the need for endoscopic intervention, risk of re-bleeding, and 30-day mortality in non-variceal bleedings.

    Emergency upper gastrointestinal endoscopy is performed within the first 12 hours in high-risk patients who present to the hospital's emergency department with acute upper gastrointestinal system bleeding. However, it may not always be feasible to adhere to this timeframe, and endoscopy can be performed up to 24 hours after appropriate resuscitation, depending on the expertise of the personnel.

    In investigators' prospective study, researcher aimed to facilitate the identification of patients who require intervention and undergo endoscopic intervention (e.g., epinephrine injection, hemoclips, thermal coagulation, argon plasma coagulation, etc.) among those who underwent endoscopy within the first 24 hours after admission to the hospital's emergency department with a diagnosis of non-variceal acute upper gastrointestinal system bleeding. Investigators sought to achieve this by determining the relevant parameters related to their clinical and laboratory findings, comorbidities, and demographic characteristics at the time of admission. This approach aims to reduce hospital admissions, hospital stay, and costs, and particularly to minimize interventional procedures during seizures and decrease complications. As of August 2022, patients who applied to the Ankara Bilkent City Hospital emergency department were followed up.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    262 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Factors Predicting the Need for Endoscopic Intervention in Non-variceal Upper Gastrointestinal Bleeding
    Actual Study Start Date :
    Aug 11, 2022
    Actual Primary Completion Date :
    Jul 29, 2023
    Anticipated Study Completion Date :
    Aug 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Endoscopic intervention [First 24 hours after hospital admission]

      Mechanical treatment (eg hemoclips, tape, etc.), injection therapy (eg epinephrine etc.), thermal coagulation (eg heater probe etc.)

    Secondary Outcome Measures

    1. İntensive care hospitalization [30 days after admission to hospital]

      Intensive care unit (ICU) admission of patients presenting to the hospital due to non-variceal upper gastrointestinal system bleeding either at the time of admission or within 30 days after hospitalization for any reason.

    2. Mortality [30 days after admission to hospital]

      Death within 30 days of hospital admission with non-variceal upper gastrointestinal bleeding

    3. Rebleeding [30 days after admission to hospital]

      Rebleeding within 30 days of hospital admission with non-variceal upper gastrointestinal bleeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who present to our hospital with a diagnosis of non-variceal upper gastrointestinal bleeding

    • Patients who undergo endoscopy within the first 24 hours after hospital admission

    Exclusion Criteria:
    • Patients who have variceal bleeding

    • Lower gastrointestinal system bleeding

    • Individuals who are under the age of 18

    • Patients who do not undergo endoscopy within the first 24 hours after hospital admission

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara Bilkent City Hospital Ankara Turkey

    Sponsors and Collaborators

    • Ankara City Hospital Bilkent

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    numanaydin, Medical Doctor, Ankara City Hospital Bilkent
    ClinicalTrials.gov Identifier:
    NCT05979025
    Other Study ID Numbers:
    • AnkaraCHBilkent-NA-TEZ
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 14, 2023