GIT - Gastrointestinal Tract HemorrhageNCT06886880
Endoscopic Findings in Patients With Upper GIT Bleeding
An observational study of GIT - Gastrointestinal Tract Hemorrhage, run by Assiut University.
Trial summary
This study aims to identify the causes of upper gastrointestinal bleeding through comprehensive evaluation via upper endoscopy in Assiut University Hospital and contribute valuable insights into effective management strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIT - Gastrointestinal Tract Hemorrhage
- What is being tested?
- endoscope
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: 2.4.1- Type of the study: Prospective cross-sectional study . 2.4. 2- Study Setting: Assiut University Hospital , Alraghy Hospital, Endoscopy centre. 2.4. 3- Study subjects: 1. Inclusion criteria: Adult patients present with upper GIT bleeding of both gender older than 18 years old 2. Exclusion criteria: 1. Patients younger than 18 2. Pregnant women 3. patients with end stage disease that not fit for endoscopic intervention
Who may be able to join
- Adult patients present with upper GIT bleeding of both gender older than 18 years old
Who cannot join
- 1- Patients younger than 18 2- Pregnant women 3- patients with end stage disease that not fit for endoscopic intervention
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endoscopic Findings in Patients With Upper GIT Bleeding in Assiut University Hospital
This study aims to identify the causes of upper gastrointestinal bleeding through comprehensive evaluation via upper endoscopy in Assiut University Hospital and contribute valuable insights into effective management strategies.
Read the detailed description
Upper gastrointestinal bleeding (UGIB) is a critical medical situation that arises when there is bleeding proximal to the ligament of Treitz [1]. This condition is a leading cause of morbidity and mortality, with death rates ranging from 5-14% and increasing to over 40% in patients with liver disease[2] Symptoms of UGIB may include anemia, hematemesis, melena, or hematochezia [3].
Neoplasms, arteriovenous malformations, esophageal varices, gastric ulcers, gastric erosions, duodenal ulcers, reflux esophagitis, Mallory-Weiss tears, and fundal varices are causes of UGIB [4].
Current strategies for managing UGIB emphasize early recognition and intervention. Endoscopy is the primary diagnostic and therapeutic modality, allowing for direct visualization of the gastrointestinal tract and enabling interventions such as cauterization, clipping, or band ligation to control bleeding [5]. Recent advancements in endoscopic techniques have improved outcomes by facilitating earlier detection and treatment of UGIB episodes. For instance, the use of hemostatic powders and over-the-scope clips has shown promise in managing refractory cases[6,7].
Endoscopic therapies may have resulted in earlier detection and treatment of UGIB, which could have led to a reduction in the incidence and severity of the condition. Upper GI endoscopy is considered the primary modality for identifying the underlying etiology and administering appropriate therapeutic measures to the patient present with upper GIT bleeding by ligation ,clips, electrocoagulation or by taking biopsies that help in diagnosis. The rationale for this research stems from the need to enhance understanding of UGIB's underlying causes and improve patient outcomes through timely endoscopic intervention. By identifying specific etiologies through upper endoscopy[8,9].
- Conditions
- GIT - Gastrointestinal Tract Hemorrhage
- Being tested
- endoscope
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopeDevice
findings in upper GIT Endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Findings in patients with upper GIT Bleeding
identify the causes of upper gastrointestinal bleeding through comprehensive evaluation via upper endoscopy in Assuit University Hospital and contribute valuable insights into effective management strategies.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GIT - Gastrointestinal Tract HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Salama Faheim Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886880
- Sponsor's protocol ID
- Endoscope in GIT bleeding
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsebaey MA, Elashry H, Elbedewy TA, Elhadidy AA, Esheba NE, Ezat S, Negm MS, Abo-Amer YE, Abgeegy ME, Elsergany HF, Mansour L, Abd-Elsalam S. Predictors of in-hospital mortality in a cohort of elderly Egyptian patients with acute upper gastrointestinal bleeding. Medicine (Baltimore). 2018 Apr;97(16):e0403. doi: 10.1097/MD.0000000000010403.
PubMed 29668596
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Findings in Patients With Upper GIT Bleeding in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06886880
- Acronym / sponsor ID
- Endoscope in GIT bleeding
- Conditions
- GIT - Gastrointestinal Tract Hemorrhage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify the causes of upper gastrointestinal bleeding through comprehensive evaluation via upper endoscopy in Assiut University Hospital and contribute valuable insights into effective management strategies.
Detailed description
Upper gastrointestinal bleeding (UGIB) is a critical medical situation that arises when there is bleeding proximal to the ligament of Treitz [1]. This condition is a leading cause of morbidity and mortality, with death rates ranging from 5-14% and increasing to over 40% in patients with liver disease[2] Symptoms of UGIB may include anemia, hematemesis, melena, or hematochezia [3].
Neoplasms, arteriovenous malformations, esophageal varices, gastric ulcers, gastric erosions, duodenal ulcers, reflux esophagitis, Mallory-Weiss tears, and fundal varices are causes of UGIB [4].
Current strategies for managing UGIB emphasize early recognition and intervention. Endoscopy is the primary diagnostic and therapeutic modality, allowing for direct visualization of the gastrointestinal tract and enabling interventions such as cauterization, clipping, or band ligation to control bleeding [5]. Recent advancements in endoscopic techniques have improved outcomes by facilitating earlier detection and treatment of UGIB episodes. For instance, the use of hemostatic powders and over-the-scope clips has shown promise in managing refractory cases[6,7].
Endoscopic therapies may have resulted in earlier detection and treatment of UGIB, which could have led to a reduction in the incidence and severity of the condition. Upper GI endoscopy is considered the primary modality for identifying the underlying etiology and administering appropriate therapeutic measures to the patient present with upper GIT bleeding by ligation ,clips, electrocoagulation or by taking biopsies that help in diagnosis. The rationale for this research stems from the need to enhance understanding of UGIB's underlying causes and improve patient outcomes through timely endoscopic intervention. By identifying specific etiologies through upper endoscopy[8,9].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 2.4.1- Type of the study: Prospective cross-sectional study . 2.4. 2- Study Setting: Assiut University Hospital , Alraghy Hospital, Endoscopy centre. 2.4. 3- Study subjects: 1. Inclusion criteria: Adult patients present with upper GIT bleeding of both gender older than 18 years old 2. Exclusion criteria: 1. Patients younger than 18 2. Pregnant women 3. patients with end stage disease that not fit for endoscopic intervention
Key inclusion criteria (1 listed)
- Adult patients present with upper GIT bleeding of both gender older than 18 years old
Key exclusion criteria (1 listed)
- 1- Patients younger than 18 2- Pregnant women 3- patients with end stage disease that not fit for endoscopic intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopefindings in upper GIT Endoscopy | Device | – |
Primary outcome
Endoscopic Findings in patients with upper GIT Bleeding
Time frame: one year
identify the causes of upper gastrointestinal bleeding through comprehensive evaluation via upper endoscopy in Assuit University Hospital and contribute valuable insights into effective management strategies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 29668596Elsebaey MA, Elashry H, Elbedewy TA, Elhadidy AA, Esheba NE, Ezat S, Negm MS, Abo-Amer YE, Abgeegy ME, Elsergany HF, Mansour L, Abd-Elsalam S. Predictors of in-hospital mortality in a cohort of elderly Egyptian patients with acute upper gastrointestinal bleeding. Medicine (Baltimore). 2018 Apr;97(16):e0403. doi: 10.1097/MD.0000000000010403.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of GIT - Gastrointestinal Tract Hemorrhage, run by Assiut 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: opening soon, as of the sponsor's last update on 20 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebram Sala,ma (01280541696, Ebram.14223993@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic Findings in patients with upper GIT Bleeding (time frame: one year). 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 NCT06886880, which also lists 1 linked publication.
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 Mar 2025.