Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding
The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to smal
| Condition(s) | Small Bowel Bleeding |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups. |
| Who can participate | Inclusion Criteria: * Age ≥ 18 years * New onset of acute gastrointestinal bleeding defined as: 1. The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS 2. Hemoglobin drop of ≥ 20 g/L from patient's baseline * Have capacity to consent * Hemodynamically stable (i.e. blood pressure \>100/60 or pulse \<110 at the time of consent) * Initial gastroscopy negative for active bleeding or potential bleeding source Exclusion Criteria: * Inability to provide consent due to lack of capacity, language barrier or other reasons * Pregnant women * Prior history of small bowel surgery * Prior history of Crohn's disease * Prior history of small bowel or colonic strictures * Prior history of abdominal radiation |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | University of Alberta |
| Locations | Edmonton, Alberta, Canada |
| Start date | 2021-09-01 |
| NCT ID | NCT05108844 |
| Official listing | https://clinicaltrials.gov/study/NCT05108844 |