Upper Gastrointestinal Bleeding
Conditions
Keywords
capsule endoscopy, PillCam, upper Endoscopy, emergency Department, upper gastrointestinal bleeding, GI bleed
Brief summary
This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).
Detailed description
Video capsule endoscopy (VCE) was initially approved in 2001 by the Food and Drug Administration. VCE offers potential advantages over traditional EGD including the ability to be performed 24 hours a day without sedation and interpreted at the bedside by emergency physicians. In addition, VCE is much less invasive, is painless, and enables the patient to pursue normal daily activities after the procedure. Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to safely discharge low risk patients for outpatient evaluation and management. Our secondary objective is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal (GI) tract. Research Coordinator will screen potential patients with signs of upper GI bleeding. Patients who screen as eligible will be approached about potential interest, to review of inclusion and exclusion criteria, and obtain informed consent. Research Coordinator will calculate traditional risk stratification scores and once enrolled, all subjects will be randomized to either Active Control (AC) \[admission plus EGD within hospital stay\] or experimental Capsule Endoscopy Risk Assessment (CERA) in ED. Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency department.Within 2 hours of presenting to the ED, patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus. Upon passing the pylorus, we will record 5 more minutes of video or until battery runs out - whichever occurs first. Patient data will be completed using a standardized data collection tool including the following elements: chief complaint of patient, history of present illness, past medical history, pertinent lab findings, current medications, vital signs, focused physical exam findings and all relevant treatments administered during the ED and hospital stay. For Active Control (AC) group each patient will be admitted. During hospital admission, EGD will be performed on all subjects and hemostasis therapy applied as necessary. The study team decided against mandating that EGD be performed within 24 hours of hospital admission.
Interventions
DEVICEPillCam UGI
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
OTHERStandard of Care
Patient was admitted to hospital for care and received in-patient EGD.
Sponsors
Medtronic
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\. Individuals aged ≥ 18 years presenting to the Emergency Department with likely upper GI bleed (bloody emesis and/or coffee ground vomiting and/or melena) that has occurred within the previous 48 hours.
Exclusion criteria
1. Upper GI Bleed with hemodynamic instability (BP\<90 mmHg, pulse\>120 beats per minute, and Hgb \< 9 g/dL) 2. High Risk Upper GI Bleed (Glasgow Blatchford Score\* ≥ 6) 3. Signs, symptoms or history of liver cirrhosis or liver failure 4. Signs, symptoms or history of decompensated heart failure or congestive heart failure 5. Presumed Pregnant, trying to conceive or breastfeeding 6. Known history of gastric cancer 7. Known history of gastric or esophageal varices 8. GI surgery within the last 6 months 9. Prior enrollment in the CHEER Study 10. Prisoner or Ward of State 11. Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician 12. Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure) that changes Gastrointestinal anatomy 13. Known history of gastroparesis, esophageal stricture or Crohn's disease 14. Altered mental status that limits the ability to swallow a capsule 15. Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days 16. Consumed medications within the past 12 hours that may coat the upper GI tract such as antacids or sucralfate or Maalox and potentially limits capsule visualization 17. Patient either refuses or is unable to get traditional EGD 18. Patient does not have reliable contact information - no phone, no permanent address 19. Patient refuses 20. Unable to provide written consent 21. Non-English speaker 22. Suspected middle or lower GI bleeding 23. Treating ED Physician is not amenable to admission or discharge based on randomization or Video Capsule Endoscopy results. \* As a modification, the GBS Score modified from the traditional GBS score to reduce the Hemoglobin cut-off for 6 points from 10g/dL to 9 g/dL (see Appendix B, CHEER 4; patient screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | 30 Days | Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Video Capsule Endoscopy | 30 Days | Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events at Day 7 and Day 30 | 30 Days | Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group) |
| Patient Satisfaction With VCE Procedure | 30 Days | — |
| Hospital Length of Stay | 30 days | — |
| ED Length of Stay | 30 Days | — |
| GI Physician Final Read and Site Physician Agreement on VCE Results | 30 Days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Control Standard of Care: Patient was admitted to hospital for care and received in-patient EGD. | 13 |
| Experimental PillCam UGI: An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract. | 11 |
| Total | 24 |
Baseline characteristics
| Characteristic | Active Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 47.0 years | 55.0 years | 51.5 years |
| Race/Ethnicity, Customized Race Black | 7 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 13 participants | 11 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
Primary
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Control | Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | 3 Participants |
| Experimental | Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | 9 Participants |
Secondary
Detection Rate of Video Capsule Endoscopy
Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation.
Time frame: 30 Days
Population: This is a subgroup analysis. The reason only the experimental arm is reported here is because only the experimental arm got the VCE.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Control | Detection Rate of Video Capsule Endoscopy | Clean stomach and duodenum i.e. no fresh blood /coffee grounds | 8 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | Upper GI pathology non-causative/ incidental. | 1 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | A low grade non-Variceal lesion (Forrest IIc, III) | 1 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | Coffee ground blood | 2 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | Fresh blood or evidence of active bleeding | 1 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | Other sources of non-variceal bleeding / pathology | 3 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | VCE passed the pylorus | 9 participants |
| Active Control | Detection Rate of Video Capsule Endoscopy | Needs endoscopic hemostasis | 2 participants |
Other Pre-specified
ED Length of Stay
Time frame: 30 Days
Other Pre-specified
GI Physician Final Read and Site Physician Agreement on VCE Results
Time frame: 30 Days
Other Pre-specified
Hospital Length of Stay
Time frame: 30 days
Other Pre-specified
Number of Participants With Serious Adverse Events at Day 7 and Day 30
Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group)
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Control | Number of Participants With Serious Adverse Events at Day 7 and Day 30 | 0 Participants |
| Experimental | Number of Participants With Serious Adverse Events at Day 7 and Day 30 | 0 Participants |
Other Pre-specified
Patient Satisfaction With VCE Procedure
Time frame: 30 Days