Endoscopic Fluid Collection for Small Intestinal Conditions

Overseen By Christine Chang, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The small intestine is an understudied frontier of microbiome research. While aspiration during endoscopy is considered the gold standard to assess small bowel bacteria, the tools for sterile retrieval are primitive and poorly validated. Endoscopic aspiration is time-consuming and prone to contamination. Inspired by plants' ability to draw water by capillary action, a novel multi-capillary sterile system was designed which is a modified version of the conventional aspiration catheter. The purpose of this study is to examine the time and volume capabilities of this catheter in suctioning various liquids compared to conventional aspiration catheter, in two groups, each includes 23 patients that going under endoscopy at GI lab at Cedars Sinai Medical Center. The investigator will collect up to 2 ml fluid from Duodenum- in first group by using the conventional catheter and in second group by using the capillary catheter. The time collection and the volume of samples in 2 groups will be compared.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications since the study involves patients already undergoing a medical procedure.

Is endoscopic fluid collection for small intestinal conditions safe?

The safety data available is primarily for capsule endoscopy, which is generally safe but can have rare complications like capsule retention or aspiration into the lungs. These complications are infrequent, and with proper patient selection and monitoring, the risks can be minimized. ^{1 2 3 4 5}

How does endoscopic fluid collection differ from other treatments for small intestinal conditions?

Endoscopic fluid collection is unique because it involves using capsule endoscopy, a non-invasive technique that allows for a complete exploration of the small intestine. This method is different from traditional treatments as it provides a safe and reliable way to diagnose and manage small intestinal conditions without the need for invasive procedures. ^{3 4 6 7 8}

Research Team

Ali Rezaie, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for men and women aged 18-85 who are already scheduled to undergo an esophagogastroduodenoscopy, a type of endoscopic examination. There are no specific exclusion criteria since the procedure is being done for medical reasons unrelated to the study.

Inclusion Criteria

I am between 18 and 85 years old and scheduled for an EGD procedure.

Exclusion Criteria

There are no exclusion criteria for this study as subjects will be undergoing the procedures for medical reasons and not for the purposes of this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endoscopy using either a standard or capillary aspiration catheter to collect fluid samples from the small intestine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events such as perforation and bleeding after the endoscopy procedure

30 minutes

1 visit (in-person)

Treatment Details

Interventions

• Capillary Endoscopy Aspiration Catheter
• Endoscopy Aspiration Catheter

Trial Overview The study tests a new capillary endoscopy aspiration catheter against the standard one during endoscopies at Cedars Sinai Medical Center. It aims to compare how well and quickly each catheter can collect fluid from the small intestine in two groups of 23 patients.

Participant Groups

Group I: Capillary Aspiration Endoscopy Catheter group Experimental Treatment 1 Intervention

Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter

Group II: Aspiration endoscopy catheter group Active Control 1 Intervention

Small intestine aspirate suction was carried out with an aspiration endoscopy catheter

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

Capsule endoscopy is a safe and effective method for examining the small bowel and colon, but there is a small risk of capsule retention, which can be managed conservatively with good outcomes.

To reduce the risk of capsule retention, careful patient selection and the use of patency capsules or imaging techniques like CT or MR enterography are recommended, although these methods do not completely eliminate the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of small bowel capsule endoscopy. Rosa, B., Dray, X., Koulaouzidis, A.[2023]

In a study of 5428 capsule endoscopy procedures, the overall incidence of adverse events (AEs) was low at 1.9%, with the most common issue being capsule retention in the small bowel, particularly in patients with inflammatory bowel disease.

Most patients experiencing AEs had mild or no symptoms, and 64.4% were successfully managed with non-surgical methods, indicating that while AEs can occur, they are generally manageable and not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. Fernández-Urién, I., Carretero, C., González, B., et al.[2022]

Three new scales for grading small-bowel cleansing during capsule endoscopy (CE) were validated in a study involving 40 patients, showing moderate to substantial reliability for intraobserver assessments, particularly for the quantitative index (QI).

The study found that the distal small bowel had poorer cleansing compared to the entire small bowel, highlighting the importance of evaluating small-bowel cleansing in CE reports to ensure quality assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Brotz, C., Nandi, N., Conn, M., et al.[2022]

Capsule endoscopy (CE) is a safe and non-invasive method that allows for thorough examination of the small intestine, making it well-accepted by patients.

Since its introduction in 2000, CE has become the gold standard for diagnosing various small bowel diseases, including obscure gastrointestinal bleeding and Crohn's disease, and is now also being applied to esophageal and colonic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsule endoscopy. Muñoz-Navas, M.[2021]

Capsule endoscopy is an innovative method for diagnosing small intestinal disorders, but it carries a risk of the capsule being accidentally aspirated into the lungs, which can lead to serious complications like respiratory failure.

Prompt recognition of this aspiration risk and immediate bronchoscopic removal of the capsule in affected patients can help prevent severe health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration of capsule endoscope and successful bronchoscopic extraction. Girdhar, A., Usman, F., Bajwa, A.[2012]

In a study of 42 patients with suspected gastrointestinal bleeding, video-capsule endoscopy (CE) successfully detected significant pathological findings in 55% of cases, including conditions like angiodysplasia and ulcers.

CE was found to be safe and effective, guiding further diagnostic and treatment decisions in 33% of the patients, suggesting it could be a key tool in diagnosing occult gastrointestinal bleeding after standard endoscopies are normal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic utility of capsule endoscopy in occult gastrointestinal bleeding]. Kraus, K., Hollerbach, S., Pox, C., et al.[2006]

An endoscopy nurse, after adequate training, can effectively identify significant images in capsule endoscopy studies, achieving excellent agreement with an endoscopist (mean kappa > 0.85).

This approach can enhance the cost-effectiveness of the procedure by reducing the time required for the endoscopist to finalize reports by approximately 5-10 minutes, without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of abnormal lesions recorded by capsule endoscopy. A prospective study comparing endoscopist's and nurse's accuracy. Bossa, F., Cocomazzi, G., Valvano, MR., et al.[2022]

Small bowel capsule endoscopy (CE) has become the primary diagnostic tool for various small bowel diseases, including obscure gastrointestinal bleeding and Crohn's disease, due to its high diagnostic yield and safety profile.

The future of CE includes advancements such as therapeutic capabilities, improved visualization techniques, and biopsy sampling, which could enhance its effectiveness and broaden its applications in gastrointestinal diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status and future perspectives of capsule endoscopy. Song, HJ., Shim, KN.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Retention of small bowel capsule endoscopy. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Capsule endoscopy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Aspiration of capsule endoscope and successful bronchoscopic extraction. [2012]

6. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostic utility of capsule endoscopy in occult gastrointestinal bleeding]. [2006]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Detection of abnormal lesions recorded by capsule endoscopy. A prospective study comparing endoscopist's and nurse's accuracy. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Current status and future perspectives of capsule endoscopy. [2020]