Gastric HemorrhageNCT05204420
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review
An observational study of Gastric Hemorrhage, run by University of Balamand at 1 site in Lebanon.
Trial summary
Patient previously healthy found to have spontaneous gastric intramural hematoma Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Hemorrhage
- What is being tested?
- Gastric wide local excision for bleeding mass
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Dec 2021to 1 Jan 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients previously healthy presenting with bleeding gastric mass
Who may be able to join
- any patient presenting with gastric bleeding tumors
Who cannot join
- patients on anticoagulants and patient with gastric medical history
Trial locations and contacts
1 site in 1 country.
About this study
Patient previously healthy found to have spontaneous gastric intramural hematoma
Read the detailed description
28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous.
- Conditions
- Gastric Hemorrhage
- Being tested
- Gastric wide local excision for bleeding mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric wide local excision for bleeding massProcedure or surgery
Laparoscopic partial gastrectomy for gastric submucosal mass
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous gastric intramural hematoma
Spontaneous gastric intramural hematoma
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Dec 2021
- Primary completion15 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric HemorrhageStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Balamand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tabbikha, University of Balamand
- Investigators
- Omar Tabbikha, MD, Principal investigator, University of Balamand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204420
- Sponsor's protocol ID
- UBalamand
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publishing a case report of our finding
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review
- ClinicalTrials.gov ID
- NCT05204420
- Acronym / sponsor ID
- UBalamand
- Conditions
- Gastric Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of BalamandUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 24 Jan 2022 (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.
Patient previously healthy found to have spontaneous gastric intramural hematoma
Detailed description
28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously healthy presenting with bleeding gastric mass
Key inclusion criteria (1 listed)
- any patient presenting with gastric bleeding tumors
Key exclusion criteria (1 listed)
- patients on anticoagulants and patient with gastric medical history
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 |
|---|---|---|
| Gastric wide local excision for bleeding massLaparoscopic partial gastrectomy for gastric submucosal mass | Procedure or surgery | – |
Primary outcome
Spontaneous gastric intramural hematoma
Time frame: 1 month
Spontaneous gastric intramural hematoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No. Publishing a case report of our finding
Related trials for Gastric Hemorrhage
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Recruiting
EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
Gastric Varices Bleeding, Cirrhosis
Not yet recruiting
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Surgical Procedures, Operative
Not yet recruitingObservational study
Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
Hemorrhagic Shock, Pediatric Trauma
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
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. This study is not recruiting at the moment.
Omar Tabbikha, MD principal investigator
University of Balamand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Hemorrhage, run by University of Balamand at 1 site in Lebanon.
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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Spontaneous gastric intramural hematoma (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2022.