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Capsule Endoscopy for Severe Hematochezia

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Brief Summary

Patients with severe hematochezia (bright red blood per rectum) may have a bleeding source proximal to the colon. Visualization of the entire gastrointestinal tract using a second-generation colon capsule endoscopy system could improve diagnostic yields and form the basis for a new approach to early diagnosis that could change guidelines and practice management in these patients. The hypothesis of this study is that urgent colon capsule endoscopy will have higher rates of lesion localization and diagnosis and reduced time to diagnosis than the standard tagged red blood cell scanning and/or angiography. In this study, the eligible patients with severe hematochezia are enrolled to undergo an evaluation with the capsule endoscopy in addition to the standard tests including a tagged RBC scan and/or an angiogram. The outcomes in terms of diagnostic yields of the capsule endoscopy will be compared to the standard tests.

Study Type
Observational
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 18 years old or older
  • Able to provide written informed consent or have a legal surrogate who can provide written consent
  • Presenting with evidence of severe ongoing hematochezia (i.e. passage of red blood or clots per rectum witnessed by a health care provider) and have a decrease in hemoglobin from baseline of 2 or more grams and/or transfusion of 1 or more units of red blood cells for resuscitation with either outpatient or inpatient start of severe hematochezia.

Exclusion Criteria:

  • Uncooperative, unable to give written informed consent personally or through a legal surrogate, or refuse to participate
  • Contraindication to undergo capsule endoscopy due to:
    • Documented or suspected bowel obstruction (partial or complete)
    • Anatomical GI abnormalities such as strictures of the foregut or small bowel
    • Inability to swallow the capsule
    • Presence of cardiac pacemakers or other implanted electromedical devices
  • American Society of Anesthesiology (ASA) class V (very severe co-morbidities and very poor prognosis for surgery or similar procedures)
  • Very severe GI bleeding with shock not responsive to IV fluid resuscitation and/or transfusions and IV medications to raise the systolic blood pressure
  • History of recent hematemesis (within 30 days), positive nasogastric, or orogastric (OG) aspirate suggesting an upper GI bleed
  • Presenting with recurrent hematochezia that has been previously diagnosed as anorectal bleeding

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Study Stats
Protocol No.
17-001825
Category
GI Disorders
Contact
Kwanmanus Suvanamas
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03616041
For detailed technical eligibility, visit ClinicalTrials.gov.