Cryobiopsy for Gastrointestinal Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Under 18, Unable to consent, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year. Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2. Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED. This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information. The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.

Do I need to stop my current medications for the trial?

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

Is cryobiopsy generally safe for humans?

Cryobiopsy, a technique used to take tissue samples, has been shown to be generally safe in studies for lung diseases, with a good safety profile. However, it can have complications like bleeding, so it should be done by experienced medical teams. ^{1 2 3 4 5}

How does cryobiopsy differ from other treatments for gastrointestinal disorders?

Cryobiopsy is unique because it uses a cryoprobe to obtain larger and better-preserved tissue samples compared to traditional biopsy methods, which can improve diagnostic accuracy. This technique, originally used for lung conditions, may offer similar benefits for gastrointestinal disorders by providing more comprehensive tissue analysis. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Cryobiopsy Probe for gastrointestinal disorders?

Cryobiopsy has been shown to obtain larger and more intact tissue samples compared to traditional methods in lung diseases, which suggests it might also be effective for gastrointestinal disorders by providing better quality samples for diagnosis. ^{4 10 11 12 13}

Who Is on the Research Team?

Guillermo Tearney, M.D PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults scheduled for an elective esophagogastroduodenoscopy with biopsy, who can give informed consent. It's not suitable for anyone where standard care would advise against it.

Inclusion Criteria

I am scheduled for a scope exam of my esophagus, stomach, and upper small intestine with a tissue sample being taken.

Able to provide informed consent

Exclusion Criteria

According to standard of care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryobiopsy and standard forceps biopsy during an elective esophagogastroduodenoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryobiopsy Probe

Trial Overview The study tests a cryobiopsy probe as a less invasive way to obtain intestinal tissue samples in adults, which could help diagnose and treat environmental enteric dysfunction (EED) in resource-limited settings.

How Is the Trial Designed?

Group I: Cryobiopsy probe as a tool for biopsy Experimental Treatment 1 Intervention

Cryobiopsy probe, administered to study participants.Testing the efficacy of a novel cryobiopsy probe in acquiring tissue samples.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Published Research Related to This Trial

Cryobiopsy, a new bronchoscopic technique for lung biopsy, can obtain larger and better-preserved tissue samples than traditional methods, with a diagnostic yield of 70% to 80% for diffuse parenchymal lung disease.

The variability in cryobiopsy techniques and definitions of diagnostic yield across different centers makes it challenging to compare results and assess complications, highlighting the need for standardized protocols and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. Lentz, RJ., Argento, AC., Colby, TV., et al.[2020]

Transbronchial lung cryobiopsy is a promising technique for diagnosing interstitial lung disease and thoracic malignancies, offering a high diagnostic yield and a good safety profile compared to traditional surgical lung biopsies, which carry higher risks.

Cryosurgical techniques, including cryorecanalization, are effective for managing central airway obstructions, but they require specialized centers and experienced teams to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Safety of Bronchoscopic Cryotechniques-A Comprehensive Review. Husnain, SMN., Sarkar, A., Huseini, T.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Feasibility study of cryobiopsy for practical pathological diagnosis of primary lung cancer including immunohistochemical assessment. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Mucosal cryobiopsies: a new method for studying airway pathology in asthma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Bronchoscopic mucosal cryobiopsies as a method for studying airway disease. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Cryobiopsy vs. Forceps Biopsy for Interstitial Lung Diseases, Lung Tumors, and Peripheral Pulmonary Lesions: An Updated Systematic Review and Meta-Analysis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Utility and Safety of Bronchoscopic Cryotechniques-A Comprehensive Review. [2023]

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

Feasibility of a Supraglottic Airway Device for Transbronchial Lung Cryobiopsy-A Retrospective Analysis. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pleural Cryobiopsy vs. Forceps Biopsy for Evaluation of Undiagnosed Pleural Effusion: A Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. [2020]

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

Diagnostic Value of Transbronchial Lung Cryobiopsy using an Ultrathin Cryoprobe and Guide Sheath for Peripheral Pulmonary Lesions. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[Transbronchial cryobiopsies: an alternative for surgical lung biopsy]. [2021]

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

Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. [2010]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility and utility of transbronchial cryobiopsy in precision medicine for lung cancer: Prospective single-arm study. [2020]