Videocapsule Endoscopy for Gastrointestinal Bleeding
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Pregnancy, Small bowel surgery, Crohn's, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if using a small camera pill when an initial test fails to find bleeding in patients can improve outcomes. It aims to help doctors find hidden bleeding sources more quickly and comfortably, potentially reducing hospital stays and costs.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Videocapsule Endoscopy for gastrointestinal bleeding?
Research shows that videocapsule endoscopy is highly effective in identifying the source of obscure gastrointestinal bleeding and is recommended as the first choice for diagnosing small bowel bleeding. It has a high diagnostic yield, meaning it is very good at finding the cause of bleeding, which can help doctors decide on the best treatment.
12345Is videocapsule endoscopy safe for humans?
Videocapsule endoscopy is considered a safe procedure for studying small bowel bleeding, and it has been used effectively in both routine and emergency settings.
34678How does videocapsule endoscopy differ from other treatments for gastrointestinal bleeding?
Videocapsule endoscopy is unique because it is a non-invasive procedure that allows for a complete examination of the small bowel, which is often difficult to reach with traditional methods. Unlike other treatments, it involves swallowing a small capsule with a camera that captures images of the digestive tract, making it a first-line option for diagnosing small bowel bleeding.
39101112Eligibility Criteria
This trial is for adults over 18 who are stable after a new episode of upper gastrointestinal bleeding, evidenced by dark stools or a significant drop in hemoglobin. They must have had an initial negative gastroscopy and be able to consent. It's not for those with prior abdominal radiation, Crohn's disease, small bowel surgery or strictures, language barriers affecting consent, or pregnant women.Inclusion Criteria
I am 18 years old or older.
My blood pressure is stable and within normal ranges.
I am able to understand and agree to the study's procedures and risks.
+2 more
Exclusion Criteria
I have had radiation therapy to my abdomen before.
I have had narrowings in my small intestine or colon before.
Pregnant women
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Initial Diagnostic
Participants undergo initial gastroscopy to confirm negative results for upper gastrointestinal bleeding
1 day
1 visit (in-person)
Early Small Bowel Investigation
Participants in the experimental group undergo videocapsule endoscopy immediately after negative gastroscopy
1 day
1 visit (in-person)
Colonoscopy
Participants in the active comparator group undergo bowel preparation and colonoscopy the next day after negative gastroscopy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after diagnostic procedures
4 weeks
Participant Groups
The study tests if doing an early videocapsule endoscopy right after a negative gastroscopy can improve outcomes for patients with suspected upper GI bleeding compared to the standard method which usually involves a colonoscopy first. Outcomes include diagnostic accuracy, number of procedures needed, hospital stay length, mortality rates and costs.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early small bowel investigationExperimental Treatment1 Intervention
Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy
Group II: ColonoscopyActive Control1 Intervention
Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alberta HospitalEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
An experience of capsule endoscopy from a tertiary care hospital in Pakistan. [2019]To evaluate the effectiveness of capsule endoscopy in the management of patients with obscure gastrointestinal bleeding.
A multicenter randomized comparison of the Endocapsule and the Pillcam SB. [2008]Video capsule endoscopy has been shown to be the single most effective endoscopic procedure for identifying the source of obscure GI bleeding (OGIB).
Role of Video Capsule in Small Bowel Bleeding. [2021]Video capsule endoscopy has an essential role in the diagnosis and management of small bowel bleeding and is the first-line study recommended for this purpose. This article reviews the risk factors for small bowel bleeding, optimal timing for video capsule endoscopy testing, and algorithms recommended for evaluation. Used primarily for the assessment of nonacute gastrointestinal blood loss, video capsule endoscopy has an emerging role for more urgent use in emergency settings and in special populations. Future software incorporation of neural networks to enhance lesion detection will likely result in an augmented role of video capsule endoscopy in small bowel bleeding.
Clinical consequences of videocapsule endoscopy in GI bleeding and Crohn's disease. [2016]Videocapsule endoscopy (VCE) has a high diagnostic yield in the analysis of GI bleeding and Crohn's disease. Little information is available on the impact of VCE findings on clinical care.
Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. [2016]Capsule endoscopy improves the diagnostic yield in patients with obscure gastrointestinal (GI) bleeding, but whether it improves outcomes is uncertain.
Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding. [2022]There are limited data on the safety of colonoscopy in patients with lower gastrointestinal bleeding (LGIB). We examined the various adverse events associated with colonoscopy in acute LGIB compared with non-GIB patients.
Risk of Gastrointestinal Endoscopic Procedure-Related Bleeding in Patients With or Without Continued Antithrombotic Therapy. [2021]Prospective studies on bleeding risk during/after gastrointestinal endoscopic procedures are rare.
Indications for small bowel capsule endoscopy and its safety and diagnostic yield in Mexican patients. Experience at a tertiary care hospital center. [2021]Appearing in the year 2000, capsule endoscopy revolutionized the study of the small bowel. It is the gold standard for the study of small bowel bleeding and is considered a safe procedure.
Extraction and processing of videocapsule data to detect and measure the presence of villous atrophy in celiac disease patients. [2017]Videocapsule endoscopy is a relative new method to analyze the gastrointestinal tract for the presence of pathologic features. It is of relevance to detect villous atrophy in the small bowel, which is a defining symptom of celiac disease.
[Capsule endoscopy: evidence-based indications in 2020.] [2022]Videocapsule endoscopy is, by far, one of the most important milestones in the technological development of endoscopy in the last twenty years. The introduction and spread of videocapsule endoscopy in clinical practice revolutionized the management of small bowel's diseases, allowing a high-quality, extensive examination of its whole mucosal surface. Because of its technical features, videocapsule endoscopy does not allow any direct therapeutic interventions but, compared to other techniques, it is minimally invasive, radiation-free and has an excellent safety profile. The most common indication for videocapsule endoscopy is suspected small bowel bleeding, although other conditions (such as coeliac disease, hereditary polyposis syndromes and, above all, Crohn's disease) may benefit from its use, as highlighted by several studies in recent years. The aim of this paper is to provide a wide overview on indications, limitations and future perspectives of videocapsule endoscopy: by 2020, this technique has become a valuable and irreplaceable tool for the study of the small bowel, changing the patients' management in many clinical scenarios.
[Technical aspects, indications and results of small bowel videocapsule endoscopy]. [2019]Videocapsule endoscopy is a new non-invasive endoscopic tool useful for small bowel examination.
[Role of endoscopy in the management of obscure gastrointestinal bleeding]. [2009]Obscure gastrointestinal bleeding is defined as a blood loss in the digestive tract without etiology found at upper digestive endoscopy and colonoscopy. Small bowel lesions, in particular angiodysplasias, are the most frequent cause. Endoscopic examination of the small bowel can be performed using an enteroscope (with or without balloon) or a videocapsule. Videocapsule endoscopy is a minimally invasive procedure, and it allows complete small bowel exploration in 80% of cases (vs. 40-80% with balloon-aided enteroscopy). In practice, videocapsule endoscopy is the first line exam, followed by enteroscopy for biopsy sampling or treatment. In case of completely negative investigations and persistent bleeding, videocapsule endoscopy may be repeated, generally after repeat upper digestive endoscopy and colonoscopy.