RECRUITING

Capsule Endoscopy for Severe Hematochezia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-10

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03616041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Dennis M. Jensen, MD

PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Study Locations (Sites)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: CURE Digestive Diseases Research Center

Dennis M. Jensen, MD, PRINCIPAL_INVESTIGATOR, VA Greater Los Angeles Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-10

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-02-10

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

Severe hematochezia

Additional Relevant MeSH Terms

Hematochezia