Using capsule endoscopy to diagnose severe rectal bleeding

Video Capsule Endoscopy for Lesion Localization and Diagnosis in Patients With Severe Hematochezia

This study is testing a new type of capsule endoscopy to see if it can better find the cause of severe rectal bleeding compared to standard tests.

Quick facts

• Study type: Observational
• Enrollment: 23 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CURE Digestive Diseases Research Center (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT03616041 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of a second-generation colon capsule endoscopy system in patients with severe hematochezia, which is the passage of bright red blood per rectum. The study aims to compare the diagnostic yields and time to diagnosis of capsule endoscopy against standard methods like tagged red blood cell scanning and angiography. Eligible patients will undergo capsule endoscopy in addition to these standard tests to determine the best approach for identifying the source of bleeding. The goal is to improve diagnostic accuracy and potentially influence future clinical guidelines for managing severe hematochezia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are experiencing severe ongoing hematochezia and have a significant drop in hemoglobin levels.

Not a fit: Patients with contraindications to capsule endoscopy, such as bowel obstruction or certain anatomical abnormalities, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to quicker and more accurate diagnoses for patients experiencing severe rectal bleeding.

How similar studies have performed: While there is limited consensus on the best approach for severe hematochezia, this study explores a novel use of capsule endoscopy that has not been widely tested in this context.

Eligibility criteria

Inclusion Criteria:

1. 18 years old or older
2. Able to provide written informed consent or have a legal surrogate who can provide written consent
3. 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:

1. Uncooperative, unable to give written informed consent personally or through a legal surrogate, or refuse to participate
2. Contraindication to undergo capsule endoscopy due to:

   1. Documented or suspected bowel obstruction (partial or complete)
   2. Anatomical GI abnormalities such as strictures of the foregut or small bowel
   3. Inability to swallow the capsule
   4. Presence of cardiac pacemakers or other implanted electromedical devices
3. American Society of Anesthesiology (ASA) class V (very severe co-morbidities and very poor prognosis for surgery or similar procedures)
4. Very severe GI bleeding with shock not responsive to IV fluid resuscitation and/or transfusions and IV medications to raise the systolic blood pressure
5. History of recent hematemesis (within 30 days), positive nasogastric, or orogastric (OG) aspirate suggesting an upper GI bleed
6. Presenting with recurrent hematochezia that has been previously diagnosed as anorectal bleeding

Where this trial is running

Los Angeles, California and 1 other locations

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

Study contacts

• Principal investigator: Dennis M. Jensen, MD — VA Greater Los Angeles Healthcare System

Conditions: Hematochezia, Severe hematochezia