Capsule Endoscopy for Severe Hematochezia

Recruiting now

Conditions studied: Hematochezia

In brief

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.

Key facts

Study ID

NCT03616041

Run by

CURE Digestive Diseases Research Center

People needed

23

Starts

2021-02-10

Expected to finish

2024-12-31

Last updated by the study team

2024-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.