Spontaneous Gastric Intramural Hematoma: Case Report and... | NCT05204420

Studies
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review

NCT05204420

Sponsor

University of Balamand

Status

Completed

Last Update Posted

Jan 24, 2022Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Gastric Hemorrhage

Interventions

Gastric wide local excision for bleeding mass

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Jan 12, 2022

First Posted Date

Jan 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2022

Last Update Posted Date

Jan 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric wide local excision for bleeding mass	Procedure	Laparoscopic partial gastrectomy for gastric submucosal mass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spontaneous gastric intramural hematoma	Spontaneous gastric intramural hematoma	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any patient presenting with gastric bleeding tumors

Exclusion Criteria:

patients on anticoagulants and patient with gastric medical history

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients previously healthy presenting with bleeding gastric mass

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omar Tabbikha, MD	University of Balamand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Balamand		Beirut			Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Description

Publishing a case report of our finding

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided