Endoscopic Ultrasound for Gastrointestinal Cancer

Overseen By Barbara Broome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orlando Health, Inc.

Disqualifiers: Age < 18, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different ultrasound tools to determine which one better examines lumps or bumps inside the digestive system. One tool is the standard device doctors use, while the other is a new gadget called the EndoSound Vision System. The trial aims to discover if the new tool provides clearer images or better results. Individuals needing an endoscopic ultrasound examination of areas like the pancreas, bile duct, or certain parts of the stomach and intestines might be suitable for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance diagnostic tools for digestive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the EndoSound Visual System is safe for evaluating gastrointestinal lesions?

Research has shown that endoscopic ultrasound (EUS) is a well-tolerated method for examining the digestive system. Studies on the EndoSound Vision System have demonstrated its high effectiveness, achieving a 90% success rate in procedures and 100% success in collecting samples from the esophagus. This indicates it is both effective and safe for patients.

The standard echoendoscope, commonly used for digestive exams, is also considered safe. It reduces cancer rates through regular screening and improves patient survival, making it a reliable tool in medical practice.

Both the EndoSound Vision System and the standard echoendoscope offer safe options for examining and diagnosing conditions in the digestive system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using endoscopic ultrasound (EUS) for gastrointestinal cancer because it offers a more detailed view of the digestive tract's layers compared to traditional imaging methods. This enhanced imaging capability can lead to earlier and more accurate detection of cancerous growths, which is crucial for effective treatment. Additionally, the trial compares the EndoSound Vision System with the standard echoendoscope, potentially highlighting improvements in image quality or ease of use. These advancements could streamline diagnosis and improve patient outcomes.

What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?

Research has shown that endoscopic ultrasound is a highly accurate method for assessing gastrointestinal cancers. In this trial, participants will join one of two arms. Participants in one arm will use the EndoSound Vision System, which studies have shown to be 79% to 87% accurate in determining the depth of cancer spread. This accuracy is crucial for diagnosing and planning treatment for cancers in the esophagus, stomach, and colon.

Participants in the other arm will use the standard echoendoscope, a well-established tool that significantly lowers cancer rates by aiding early detection and treatment. It is considered the best method for diagnosing stomach cancer because it allows doctors to see and sample suspicious areas. Both tools are effective, but the EndoSound Vision System may offer new benefits in accuracy and efficiency. ^{2 4 6 7 8}

Who Is on the Research Team?

Ji Young Bang, MD MPH

Principal Investigator

Orlando Health, Digestive Health Institute

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like pancreatic cancer, bile duct cancer, and various gastrointestinal tumors. Participants should be suitable candidates for an endoscopic ultrasound examination.

Inclusion Criteria

I am having an EUS exam for issues in my pancreas, bile duct, lymph nodes, or gastrointestinal tract.

Exclusion Criteria

I am under 18 years old.

Unable to obtain consent for the procedure from either the patient or LAR

Intrauterine pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endoscopic ultrasound examination using either the EndoSound Vision System or the standard echoendoscope

1 day

1 visit (in-person)

Follow-up

Participants are monitored for procedure-related adverse events and diagnostic adequacy of procured specimens

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic ultrasound examination

Trial Overview The study is testing a new device called the EndoSound Visual System against the standard echoendoscope to see which is better at evaluating lesions in the gastrointestinal tract.

How Is the Trial Designed?

Group I: EndoSound Vision System Active Control 1 Intervention

EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Group II: Standard echoendoscope Active Control 1 Intervention

Standard echoendoscope will be used and EUS examination will be performed per standard of care.

Endoscopic ultrasound examination is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as EUS for:

• Staging tumors of the gastrointestinal tract
• Evaluating abnormalities of the pancreas
• Diagnosing common bile duct stones
• Evaluating adenopathy and masses of the posterior mediastinum

Approved in United States as EUS for:

• Staging tumors of the gastrointestinal tract
• Evaluating abnormalities of the pancreas
• Diagnosing common bile duct stones
• Evaluating adenopathy and masses of the posterior mediastinum
• Pre-operative staging of esophageal cancer
• Gallbladder drainage for acute cholecystitis

Approved in Canada as EUS for:

• Similar to those in the European Union and United States, given the widespread acceptance and use of EUS in gastroenterology

Who Is Running the Clinical Trial?

Orlando Health, Inc.

Lead Sponsor

Trials

32

Recruited

15,100+

Published Research Related to This Trial

In a study of 2895 patients undergoing 3552 endoscopic ultrasound (EUS) procedures, only 2% experienced adverse events related to the procedure, indicating that EUS is generally safe.

Fine-needle aspiration (FNA) during EUS significantly increased the risk of adverse events, with an odds ratio of 6.43, although complications requiring hospitalization were rare and none resulted in death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of adverse events associated with upper and lower endoscopic ultrasound: a population-based cohort study. Razik, R., James, PD., Khan, R., et al.[2021]

Endoscopic ultrasound (EUS) enhances the local staging of esophageal, gastric, and rectal cancers, providing critical information that can influence patient management, especially for subepithelial masses and pancreatic diseases.

While EUS is promising, further studies are needed to confirm that its improved staging leads to better patient management and outcomes, particularly in specialized centers with extensive experience in gastrointestinal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status evaluation: endoscopic ultrasonography. American Society for Gastroenterology Endoscopy. Technology Assessment Committee. Gilbert, DA., DiMarino, AJ., Jensen, DM., et al.[2017]

Endoscopic ultrasonography significantly enhances the evaluation of gastrointestinal tumors by providing high-resolution images that improve tumor characterization and allow for more accurate TNM staging.

The earlier diagnosis and precise staging made possible by this technique enable better timing and selection of treatments like chemotherapy, radiation, and surgery, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasonography: an effective new tool for diagnosing gastrointestinal tumors. Snady, H.[2016]

Endoscopic ultrasonography (EUS) is a safe and tolerable procedure, with no reported complications and a high acceptance rate among patients, as 90% found it tolerable and 83% were willing to repeat it under similar conditions.

EUS significantly influences patient management by providing additional diagnostic information, prompting further tests in 22% of cases, and making additional examinations unnecessary in 30%, although it directly changed therapy in only 6% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance, patient acceptance, appropriateness of indications and potential influence on outcome of EUS: a prospective study in 397 consecutive patients. Allescher, HD., Rösch, T., Willkomm, G., et al.[2019]

Endoscopic ultrasound (EUS) offers high-resolution, real-time images of the gastrointestinal tract, allowing for detailed examination of its various layers.

This technique combines ultrasound technology with endoscopic visualization, enhancing diagnostic capabilities for gastrointestinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of EUS in Advanced Endoscopic Procedures and Therapeutics-Advancing the Field to Greater Heights. Mann, R., Goyal, H., Perisetti, A.[2023]

Endoscopic ultrasound, a technique using a fiberoptic endoscope with an ultrasound probe, was tested on 40 patients, revealing new diagnostic information in 20 cases, particularly beneficial for pancreatic disorders and gut-wall malignancies.

The technique demonstrated high spatial resolution, offering clearer images than traditional imaging methods, although it faced technical challenges in 6 patients, limiting its effectiveness in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper gastrointestinal endoscopic ultrasonography in gastroenterology. Shorvon, PJ., Lees, WR., Frost, RA., et al.[2008]

Endoscopic ultrasound (EUS) provides high-resolution imaging of the gastrointestinal tract, which is crucial for accurately staging gastrointestinal cancers and guiding treatment decisions in patients without distant metastases.

EUS is particularly beneficial for diagnosing submucosal tumors and localizing pancreatic endocrine tumors before surgery, although its effectiveness for benign gastroenterological disorders is still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endosonography of the gastrointestinal tract--an assessment of current status]. Rösch, T.[2016]

Endoscopic ultrasonography is a highly accurate and useful technology for staging gastrointestinal cancers and characterizing subepithelial lesions.

This technique combines flexible fiberoptic endoscopes with high-resolution ultrasound, enhancing the diagnosis of pancreaticobiliary disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic endoscopic ultrasonography in the gastrointestinal tract]. Czakó, L., Szepes, Z., Szepes, A.[2016]

In a study of 3324 patients undergoing endoscopic ultrasonography (EUS), complications were rare, occurring in only 0.3% of cases, with a mortality rate of 0.06%, primarily associated with EUS-guided fine-needle aspiration (EUS-FNA).

Despite the low complication rates, the majority of patients reported high satisfaction levels regarding the procedure, with over 90% feeling well-informed and willing to undergo EUS again, indicating that EUS is both safe and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Mortensen, MB., Fristrup, C., Holm, FS., et al.[2007]

Endoscopic ultrasonography (EUS) is a safe and effective method for diagnosing and managing various gastrointestinal and hepatobiliary conditions, with a significant increase in its use in Ontario, rising 17-fold from 2003 to 2011.

In 2011, there were notable regional disparities in EUS usage, with patients in the highest-use area being over four times more likely to receive the procedure compared to those in the lowest-use area, highlighting the need for targeted healthcare initiatives to address these gaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional differences in use of endoscopic ultrasonography in Ontario: a population-based retrospective cohort study. James, PD., Hegagi, M., Antonova, L., et al.[2020]

Endoscopic ultrasound is a safe and effective diagnostic tool for evaluating gastrointestinal diseases in children, with a significant impact on diagnosis or treatment in nearly 44% of cases (14 out of 32 children).

The procedure was primarily used for pancreatobiliary and esophageal disorders, with no complications reported, highlighting its utility in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasonography in pediatric patients with gastrointestinal disorders. Cohen, S., Kalinin, M., Yaron, A., et al.[2016]

After three years of experience with endoscopic ultrasonography (EUS), diagnostic accuracy improved to 80%, demonstrating its effectiveness in staging gastrointestinal diseases compared to standard imaging methods.

EUS influenced treatment decisions in 30-60% of patients, aligning with accepted standards and highlighting its significant role in clinical practice for gastrointestinal malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the diagnostic accuracy of the endoscopic ultrasonography results in the patients examined in a period of three years. Mesihović, R., Vanis, N., Husić-Selimović, A., et al.[2016]

In a study of 1657 endoscopic ultrasound (EUS) procedures, involving advanced endoscopy trainees (AETs) was associated with a higher adverse event (AE) rate of 4.9% compared to 2.8% when AETs were not involved, particularly during the first three months of their training.

Despite the increased risk of AEs with AET involvement, the overall diagnostic yield of EUS procedures remained high at 76%, indicating that AETs can perform EUS effectively without compromising diagnostic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Endoscopy Trainee Involvement Early in EUS Training May Be Associated with an Increased Risk of Adverse Events. Khan, U., Abunassar, M., Chatterjee, A., et al.[2022]

Endoscopic ultrasonography is a promising staging tool for gastroenterological tumors, but its direct impact on patient outcomes needs further validation through prospective studies.

The technique may improve treatment selection based on tumor stage, which could indirectly enhance treatment effectiveness for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restaging after radiotherapy and chemotherapy: value of endoscopic ultrasonography. Hordijk, ML.[2016]

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