Videocapsule Endoscopy for Gastrointestinal Bleeding

Overseen By David Yang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, Small bowel surgery, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect hidden bleeding in the digestive system using a tiny camera inside a pill, known as videocapsule endoscopy. Researchers aim to determine if using this camera immediately after a negative gastroscopy (a test that examines the stomach) can identify issues more quickly and reduce the number of tests, hospital time, and costs. Suitable candidates for this trial have recently shown signs of stomach bleeding, such as dark stools and a drop in hemoglobin (a component of blood that carries oxygen), but their initial stomach test revealed no issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diagnostic methods for future patients.

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 prior data suggests that videocapsule endoscopy is safe for gastrointestinal bleeding?

Research has shown that video capsule endoscopy (VCE) safely detects problems in the digestive system. Studies have found that patients tolerate VCE well, and it effectively identifies bleeding in the upper digestive tract. For example, tests with healthy individuals demonstrated that the capsule is safe and can detect blood without causing harm. Other research indicates that VCE can be safely used in complex medical situations, such as during the COVID-19 pandemic, to check for bleeding. Overall, VCE is considered a safe and effective method for diagnosing digestive issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Videocapsule Endoscopy (VCE) is unique because it offers a non-invasive way to explore the small intestine for sources of gastrointestinal bleeding, which traditional methods like gastroscopy or colonoscopy might miss. Unlike standard procedures, VCE involves swallowing a small, pill-sized camera that captures images as it travels through the digestive tract, providing a comprehensive view without the need for sedation or invasive instruments. Researchers are excited about this method because it has the potential to quickly identify bleeding sources, leading to faster and more accurate diagnosis and treatment for patients with gastrointestinal bleeding.

What evidence suggests that videocapsule endoscopy is effective for gastrointestinal bleeding?

Research has shown that video capsule endoscopy (VCE) effectively identifies the source of bleeding in the digestive system. In this trial, participants in the early small bowel investigation group will undergo VCE immediately after an initial negative gastroscopy. Studies have found that VCE can detect bleeding that traditional tests might miss, identifying the source in up to 75% of cases where initial tests fail. One study showed that using VCE results to guide treatment stopped the bleeding in about 87% of patients. This method allows doctors to examine the digestive tract, aiding in more effective condition management. Overall, VCE holds promise for better diagnosing and treating bleeding in the digestive system. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

My blood pressure is stable and within normal ranges.

I am able to understand and agree to the study's procedures and risks.

My first stomach exam showed no signs of bleeding.

Exclusion Criteria

I have had radiation therapy to my abdomen before.

I have had narrowings in my small intestine or colon before.

Pregnant women

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Videocapsule Endoscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: Early small bowel investigation Experimental Treatment 1 Intervention

Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy

Group II: Colonoscopy Active Control 1 Intervention

Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study of 3069 patients undergoing esophagogastroduodenoscopy (EGD) and 1116 patients undergoing colonoscopy, the risk of delayed bleeding was low even when patients continued their antithrombotic therapy, indicating a favorable safety profile for these procedures.

Immediate bleeding was observed more frequently in colonoscopy patients, particularly after cold snare polypectomy (CSP), with 14% experiencing immediate bleeding, suggesting that while delayed bleeding risk is low, immediate bleeding remains a concern, especially in certain patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Gastrointestinal Endoscopic Procedure-Related Bleeding in Patients With or Without Continued Antithrombotic Therapy. Yabe, K., Horiuchi, A., Kudo, T., et al.[2021]

In a study of 28 patients with obscure gastrointestinal bleeding, capsule endoscopy successfully completed examinations in 78.6% of cases, revealing significant findings such as ulcerations and vascular malformations in the small intestine.

The diagnostic yield of capsule endoscopy was 64.28%, and it led to resolution of bleeding in 46.42% of patients, demonstrating its effectiveness and safety compared to traditional radiological methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experience of capsule endoscopy from a tertiary care hospital in Pakistan. Qureshi, S., Ghazanfar, S., Dawood, A., et al.[2019]

Capsule endoscopy significantly improved the diagnostic yield for obscure gastrointestinal bleeding, identifying abnormalities in 30% of patients compared to only 7% with radiography, based on a study of 136 patients.

Despite the higher diagnostic yield, capsule endoscopy did not lead to better clinical outcomes, as rates of further bleeding, hospitalizations, and interventions were similar between patients who underwent capsule endoscopy and those who had radiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Laine, L., Sahota, A., Shah, A.[2016]

Videocapsule endoscopy (VCE) significantly impacts clinical management, leading to a change in treatment for 59% of patients when a definite diagnosis is made, based on a study of 150 patients.

Overall, a diagnosis was established in 68% of cases (34% definite and 34% probable), highlighting VCE's effectiveness in diagnosing gastrointestinal issues, although no direct link was found between management changes and clinical improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical consequences of videocapsule endoscopy in GI bleeding and Crohn's disease. van Tuyl, SA., van Noorden, JT., Stolk, MF., et al.[2016]

In a pivotal trial involving 51 patients with obscure gastrointestinal bleeding, both the Endocapsule (EC) and Pillcam SB (PSB) were found to be safe and had comparable diagnostic yields, effectively identifying normal and abnormal findings in the gastrointestinal tract.

The study indicated a subjective preference for the image quality of the Endocapsule over the Pillcam SB, suggesting potential advantages in visual assessment despite the inability to read the videos blind due to design differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Cave, DR., Fleischer, DE., Leighton, JA., et al.[2008]

Video capsule endoscopy is the first-line diagnostic tool for small bowel bleeding, effectively used for assessing nonacute gastrointestinal blood loss and increasingly in emergency situations.

Future advancements, such as the integration of neural networks for better lesion detection, are expected to enhance the effectiveness and application of video capsule endoscopy in managing small bowel bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Video Capsule in Small Bowel Bleeding. Wu, RM., Fisher, LR.[2021]

Videocapsule endoscopy is a groundbreaking technology that allows for a thorough examination of the small bowel's mucosal surface, making it particularly useful for diagnosing conditions like suspected small bowel bleeding and Crohn's disease.

This technique is minimally invasive, radiation-free, and has an excellent safety profile, although it does not allow for direct therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Capsule endoscopy: evidence-based indications in 2020.] Cortegoso Valdivia, P., Rondonotti, E., Pennazio, M.[2022]

Videocapsule endoscopy is a highly effective first-line examination for obscure gastrointestinal bleeding, allowing complete exploration of the small bowel in about 80% of cases, which is superior to balloon-aided enteroscopy that has a success rate of 40-80%.

In cases where initial investigations do not identify the source of bleeding, repeat videocapsule endoscopy is recommended after standard upper and lower endoscopies, highlighting its role in ongoing management of unexplained gastrointestinal bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of endoscopy in the management of obscure gastrointestinal bleeding]. Girardin, M., Bertolini, D., Frossard, JL., et al.[2009]

Videocapsule endoscopy is a non-invasive tool primarily used for diagnosing obscure gastrointestinal bleeding, helping to identify the cause and guide treatment.

It is also effective for diagnosing and evaluating conditions like Crohn's disease, small bowel neoplasia, polyposis, and celiac sprue, making it a valuable addition to endoscopic diagnostic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Technical aspects, indications and results of small bowel videocapsule endoscopy]. Karoui, S., Ouerdiane, S., Serghini, M., et al.[2019]

In a study of 161 patients with lower gastrointestinal bleeding (LGIB) and 161 matched non-GIB controls, adverse events during bowel preparation and colonoscopy were found to be low, indicating that colonoscopy is generally safe for LGIB patients.

There were no significant differences in adverse events between LGIB and non-GIB patients, even among subgroups such as the elderly or those with comorbidities, suggesting that colonoscopy does not increase risks in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding. Niikura, R., Nagata, N., Shimbo, T., et al.[2022]

Videocapsule endoscopy, combined with advanced image analysis techniques, can effectively identify and quantify villous atrophy in the small intestine, a key indicator of celiac disease, by revealing distinct texture differences and surface characteristics between celiac patients and healthy controls.

Celiac patients exhibited a rougher intestinal texture, larger surface protrusions, and reduced motility compared to controls, suggesting that these computerized methods could enhance the automated detection and mapping of villous atrophy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extraction and processing of videocapsule data to detect and measure the presence of villous atrophy in celiac disease patients. Ciaccio, EJ., Bhagat, G., Lewis, SK., et al.[2017]

Capsule endoscopy is a safe and effective method for examining the small bowel, achieving complete visualization in 84% of cases among 500 patients studied in Mexico, with a low complication rate of only 2.2% for capsule retention.

The most common reasons for performing capsule endoscopy were small bowel bleeding (65.2%), searching for tumors (14.4%), and diagnosing Crohn's disease (10.2%), with ulcers being the most frequent finding in cases of bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for small bowel capsule endoscopy and its safety and diagnostic yield in Mexican patients. Experience at a tertiary care hospital center. Blanco-Velasco, G., Mendoza-Segura, C., Solórzano-Pineda, OM., et al.[2021]

Citations

1. gastrojournal.org gastrojournal.org/article/S0016-5085(03)01998-X/fulltext

Outcome of patients with obscure gastrointestinal bleeding ... CE results led to treatments resolving the bleeding in 86.9% of patients undergoing the procedure while actively bleeding.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6501558/

A randomized controlled trial comparing efficacy of early ... This study demonstrated that early colonoscopy increased detection of SRH, increased rate of therapeutic intervention, and decreased length of hospitalization.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2782561

Assessment of Video Capsule Endoscopy in the ... Reports suggest that VCE is more effective than conventional endoscopy in detecting the site of active bleeding in many patients and hence ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224009937

Risk stratification with video capsule endoscopy leads to ... VCE offers potential advantages for the ED management of upper GI bleeding. By offering a means to examine the lumen of the GI tract to identify the presence or ...

5. giejournal.org giejournal.org/article/S0016-5107(14)02606-6/fulltext

Emergency video capsule endoscopy: A game-changing ... VCE can identify the source of bleeding in as many as 75% of cases with an initial negative result on EGD. The authors showed that emergency VCE can affect ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8325069/

Assessment of Video Capsule Endoscopy in the ... The results of this study suggest that video capsule endoscopy can serve as a safe alternative to the standard endoscopic evaluation of gastrointestinal ...

7. e-ce.org e-ce.org/journal/view.php?doi=10.5946/ce.2023.111

Novel upper gastrointestinal bleeding sensor capsule The results that we obtained from 10 healthy volunteers demonstrated the feasibility, safety, and ability of the capsule to detect blood in the upper GI tract.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3903085/

The role of capsule endoscopy in acute gastrointestinal ... The above reports show that capsule endoscopy is a feasible, safe examination, easily learned in a relatively short period of time by nongastroenterologist ...

9. 2minutemedicine.com 2minutemedicine.com/video-capsule-endoscopy-is-safe-and-effective-in-the-initial-evaluation-of-acute-gastrointestinal-bleeding-during-the-covid-19-pandemic/

Video capsule endoscopy is safe and effective in the initial ... Video capsule endoscopy is safe and effective in the initial evaluation of acute gastrointestinal bleeding during the COVID-19 pandemic.