An interventional study of PillCam UGI and Standard of Care in Upper Gastrointestinal Bleeding, sponsored by George Washington University. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by George Washington University · Not applicable, Interventional, and Diagnostic
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).
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.
Exclusion Criteria:
Video Capsule Endoscopy will be administered during ED, but video will not be read until after inpatient EGD. Subject will have hospital admission with an EGD conducted during hospital stay.
Other: Standard of Care
Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
Device: PillCam UGI
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
Patient was admitted to hospital for care and received in-patient EGD.
Also known as: SOC
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
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
Patient Satisfaction With VCE Procedure
Time frame: 30 Days
GI Physician Final Read and Site Physician Agreement on VCE Results
Time frame: 30 Days
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
ED Length of Stay
Time frame: 30 Days
Hospital Length of Stay
Time frame: 30 days
| Milestone | Active Control | Experimental |
|---|---|---|
| Started | 13 | 11 |
| Completed | 13 | 11 |
| Not completed | 0 | 0 |
Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.
| Participants | Active Control | Experimental |
|---|---|---|
| Number of Participants Discharged for Outpatient Management of Upper GI Bleeds | 3 | 9 |
Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation.
| participants | Experimental |
|---|---|
| Clean stomach and duodenum i.e. no fresh blood /coffee grounds | 8 |
| Upper GI pathology non-causative/ incidental. | 1 |
| A low grade non-Variceal lesion (Forrest IIc, III) | 1 |
| Coffee ground blood | 2 |
| Fresh blood or evidence of active bleeding | 1 |
| Other sources of non-variceal bleeding / pathology | 3 |
| VCE passed the pylorus | 9 |
| Needs endoscopic hemostasis | 2 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group)
| Participants | Active Control | Experimental |
|---|---|---|
| Number of Participants With Serious Adverse Events at Day 7 and Day 30 | 0 | 0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were monitored/assessed at Day 7 and Day 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Experimental | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Active Control | Experimental | Total |
|---|---|---|---|
| Median | 47.0 (41.0 to 54.0) | 55.0 (36.0 to 58.0) | 51.5 (38.5 to 57.5) |
| Sex: Female, Male(Participants) | Active Control | Experimental | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 9 | 7 | 16 |
| Race/Ethnicity, Customized(Participants) | Active Control | Experimental | Total |
|---|---|---|---|
| Race — Black | 7 | 9 | 16 |
| Race — Other | 2 | 0 | 2 |
| Race — White | 4 | 2 | 6 |
| Region of Enrollment(participants) | Active Control | Experimental | Total |
|---|---|---|---|
| United States | 13 | 11 | 24 |
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George Washington University