Gastrointestinal Hemorrhage
Conditions
Brief summary
Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding. The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy. To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.
Interventions
PROCEDUREVideo Capsule Endoscopy
Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.
PROCEDUREColonoscopy
The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
DEVICE1.0 X 2.5 cm 'pill' containing a camera
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Inpatients \>18 years of age presenting with lower gastrointestinal bleeding and have melenic stool
Exclusion criteria
* Unable to provide written informed consent * A probable bleeding source is identified on upper endoscopy * Pregnancy or lactation * Swallowing Disorder * Unable to tolerate sedation or anesthesia due to medical co-morbidities * Uncorrected coagulopathy (platelet count \<50,000, INR\> 2, PTT\> 2x upper limit of normal) * Known or suspected gastrointestinal obstruction or stricture * Cardiac pacemaker or other implanted electromedical device * Contraindication to bowel preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy | Up to twenty four hours | Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata |
| Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy | Up to one hour | Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Yield of Colonoscopy | Up to 7 days | Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention. |
| Number of Blood Units Transfused | Up to 60 days | Number of blood units transfused measured in units of packed red blood cells |
| Procedure Related Adverse Events | Up to 60 days | Adverse events related to the video capsule endoscopy and colonoscopy will be recorded |
| Duration of Hospital Stay | Up to 60 days | The duration of hospital stay will be recorded in number of days |
| Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding | Up to 60 days | Includes repeat endoscopies or imaging |
| Therapeutic Yield of Video Capsule Endoscopy | Up to 7 days | Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video Capsule Endoscopy Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces. It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. Its greatest use is in identifying points of bleeding and ulcers.
Video Capsule Endoscopy: Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.
1.0 X 2.5 cm 'pill' containing a camera | 2 |
| Next Day Colonoscopy Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
Colonoscopy: The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Next Day Colonoscopy | Total | Video Capsule Endoscopy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.5 years | 75.5 years | 71.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy
Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Time frame: Up to one hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Capsule Endoscopy | Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy | 0 Participants |
Primary
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy
Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Time frame: Up to twenty four hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Capsule Endoscopy | Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy | 1 Participants |
Secondary
Duration of Hospital Stay
The duration of hospital stay will be recorded in number of days
Time frame: Up to 60 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Video Capsule Endoscopy | Duration of Hospital Stay | 8 Days |
| Next Day Colonoscopy | Duration of Hospital Stay | 14.5 Days |
Secondary
Number of Blood Units Transfused
Number of blood units transfused measured in units of packed red blood cells
Time frame: Up to 60 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Video Capsule Endoscopy | Number of Blood Units Transfused | 3 Units of blood |
| Next Day Colonoscopy | Number of Blood Units Transfused | 0 Units of blood |
Secondary
Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding
Includes repeat endoscopies or imaging
Time frame: Up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Capsule Endoscopy | Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding | 2 Participants |
| Next Day Colonoscopy | Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding | 1 Participants |
Secondary
Procedure Related Adverse Events
Adverse events related to the video capsule endoscopy and colonoscopy will be recorded
Time frame: Up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Video Capsule Endoscopy | Procedure Related Adverse Events | 0 Adverse Events |
| Next Day Colonoscopy | Procedure Related Adverse Events | 0 Adverse Events |
Secondary
Therapeutic Yield of Colonoscopy
Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Capsule Endoscopy | Therapeutic Yield of Colonoscopy | 0 Participants |
Secondary
Therapeutic Yield of Video Capsule Endoscopy
Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Capsule Endoscopy | Therapeutic Yield of Video Capsule Endoscopy | 1 Participants |