Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Forceps biopsy

Endobronchial biopsy with the cryobiopsy probe

Cryobiopsy

Maik Haentschel, MD

Juergen Hetzel, MD

Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.

Objectives

Primary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

Secondary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between

* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection)

To assess differences in side effects e.g. periinterventional bleeding

Explorative Objective:

To explore tumor mutational burden with regard to

* solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* cytologic material by (EBUS-guided) TBNA
* liquid biopsy

Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.

Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures

to explore tumor mutational burden with regard to

* Solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* Cytologic material by (EBUS-guided) TBNA
* Liquid biopsy

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

assessment of differences in detection rate of molecular genetic alterations in NSCLC between

* different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding

assessment of differences in the quantity of total mutational burden between

* different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding

AstraZeneca

University Hospital Tuebingen

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphadenopathy

Lymphatic Diseases

Lymphosarcoma

FNA followed by cryobiopsy through a introducer sheath

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Core Needle Biopsy

Steven Stoffel, DO

Michal Sobieszczyk, MD

Stephen Goertzen, DO

Steven Stofffel, DO

Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.

Peripheral lymph node biopsy has long been accomplished to establish malignant and non-malignant diagnoses of lymphadenopathy. For several decades patients have undergone fine needle aspiration (FNA) and core needle biopsy (CNB) with patient's proceeding to excisional biopsy if initial less invasive procedures are inadequate. The diagnostic yield of FNA followed by CNB has remained stagnant since the 1990's with a yield range of 66-93.6% depending on multiple factors such as patient factors and malignancy type. In one study they found that between 25-30% of patients undergoing FNA followed by CNB ultimately proceed to excisional biopsy which carries a higher rate of morbidity than FNA or CNB with complications including: Seroma 6.4%, Hematoma 3.2%, Dehiscence 1.8% and prolonged pain 1.4%, vs. CNB which has a less than 1% overall complication rate. In several malignancy types, but especially in lymphoproliferative disorders there is a gap in the ability to diagnose via CNB.

After the introduction of cryobiopsy for bronchoscopic lymph node biopsy there was a significant increase in yields with the most prominent increase seen among the lymphoproliferative disorders with an increase from 69% to 95%. Cryobiopsy samples had a significant increase in architecture which is critical in proper diagnosis of lymphoproliferative disorders and genetic sequencing. Bronchoscopic cryobiopsies of mediastinal lymph nodes did not demonstrate higher complication rates compared to fine needle aspiration despite the higher yields.

Thus far in the literature the use of cryobiopsy for the diagnosis of superficial peripheral lymph nodes of suspected malignant potential has not yet been described. The use of the ERBE 2 platform for tissue biopsy has been demonstrated to improve the diagnostic yield in some situations, such as mediastinal lymphadenopathy, without statistically significant increase in complications. This study seeks to evaluate the safety, feasibility, and effectiveness of the use of the 1.1mm cryoprobe of this platform to increase diagnostic yield of peripherally obtainable lymph nodes of malignant potential without the need for additional procedures such as excisional biopsy that carry a significantly increased risk compared to current initial biopsy methods such as FNA and CNB.

Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy

Following completion of analysis, the electronic medical record query will be destroyed and the Research Database will be de-identified by removing all remaining dates.

San Antonio Uniformed Services Health Education Consortium

Pulmonary Critical Care Fellow

In patients allocated to this arm a CT guided core biopsy will be performed

If the patient is randomised to this arm, the lesion will be located via R-EBUS.

Each patient will have 3 cryo biopsies and 3 forceps biopsies. The order of the cryo biopsy and forcep biopsy will be randomly allocated at the time of initial randomisation.

CT guided biopsy will be performed by a trained interventional radiologist using core biopsy.

CT guided core biopsy

Cryo-biopsy will be performed via R-EBUS guidance. Cryo biopsy probe will be applied for 4 seconds for each biopsy and a minimum of 3 biopsies will be performed . Each patient will also have 3 forceps biopsies. The order of forceps biopsy or cryo biopsy will be randomly allocated.

Cryo-biopsy via Radial EBUS navigation

Samantha Herath, MBBS, MPhil, FRACP

Andrew Veale, FRACP

Samantha Herath, MBBS, FRACP

Obtaining a tissue sample to diagnose a PPL suspected of cancerous origin is of utmost importance. The current gold standard; Transthoracic CT guided needle biopsy approach with a success rate of \>90% comes at the expense of an increased side effect profile.

Given that most lung cancers originate in the bronchus, hence named "bronchogenic carcinoma", it would be rational to think that endobronchial route should provide the best route of sampling with the least amount of side effects. Radial EBUS has become popular during the last decade as an endobronchial modality in diagnosing PPL with minimal side effects. However, the yield is still not satisfactory in comparison to CT guided biopsy with only 73% success rate in a meta-analysis. There is also with wide variation in different centres.

Use of a new biopsy method called cryo-biopsy using the R-EBUS guide sheath may bridge the gap and increase the diagnostic yield of PPL.

Cryo biopsy had been proven to give larger sample sizes and reduced crush artefact compared to the conventional radial EBUS biopsies.

However, there have been no head to head trials comparing Cryo-probe biopsy vs. the gold standard: CT guided biopsy.

Cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence. If the yield were to be non-inferior to CT guided biopsy this would certainly be the preferred choice of biopsy for PPL in the future.

Methodology All patients with a PPL requiring a diagnostic biopsy will be eligible for recruitment to the trial. The recruited patients will be randomly allocated to either CT guided core biopsy or radial EBUS guided cryobiopsy.

Study design Multi centre intervetional,randomised control trial.

Study population:

Patients diagnosed with a PPL that requires a biopsy.

If the patient is randomised to the cryo biopsy arm:

The procedure will be done under the usual guidelines and practice of the centre as for a flexible bronchoscopy procedure.

Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is inserted covered by the GS.

Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.

The cryoprobe is then inserted through the GS to the desired location. Flexible Cryoprobe (outer diameter 1.9mm) will be applied for 4 seconds for each biopsy. The cryogen gas used will be Co2.

The probe will be retracted together with the GS and the bronchoscope en masse after each biopsy. A minimum of 1 and maximum of 3 samples will be taken.

A CXR is taken within 1 hour post procedure to access for pneumothorax. Adverse events during the procedure will be recorded. If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required; all costs will be calculated retrospectively. Minor bleeding will not be considered an additional cost as this occurs with routine bronchoscopy.

If the patient is randomised to the CT biopsy arm:

A CT guided core biopsy will be performed as per usual practice of that centre. 2-6 passes will be performed for each PPL.

A CXR 1hour post procedure will be performed to assess for pneumothorax or procedure related bleeding.

If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required all costs will be calculated retrospectively.

At the pathology:

All samples will be assessed for the size of the sample and the suitability for molecular testing. An independent pathologist will assess samples.

Economic analysis:

For both procedures: Both direct and indirect costs will be calculated. The main aim of cost analysis is to calculate the cost of side effect management in each arm to determine the most cost-effective method of sampling a PPL.

Obtaining a tissue sample to diagnose PPL suspected of cancerous origin is of utmost importance. Sampling of PPL can be done either through the chest wall (transthoracic) or through the airways that lead to the PPL (endobronchial).

The current gold slandered is Transthoracic Needle Aspiration (TTNA) approach is done by using CT guided biopsy with a success rate of \>90%. However, this success in diagnostic yield comes at the expense of increased side effect profile including a very high risk of pneumothorax (up to 30%). Half of these patients require chest drain insertion.

Given that most lung cancers originate in the bronchus, hence named "bronchogenic carcinoma", it would be rational to think that endobronchial route should provide the best way of sampling with least amount of side effects. However, the yield is still not satisfactory and has a wide confidence interval.

When diagnosing a PPL endobronchially, accurate visualisation of the lesion is the main issue. To overcome this issue various navigation methods have been used to accurately locate the PPL to improve the diagnostic yield.

The use of Radial Endo Bronchial USS (R-EBUS) is one such navigational modality. The conventional R-EBUS guided biopsies are carried out using cytology brushes and forceps biopsy. These methods had been extremely safe with \<1% pneumothorax rate however, the diagnostic yield in a meta-analysis of 14 studies is only 73%.

Use of a new biopsy method called cryo-biopsy may bridge the gap and increase the diagnostic yield of PPL.

Cryotherapy is the use of a compressed gas released at a high flow that rapidly expands and creates very low temperatures up to -89C. These very low temperatures then cause tissue to get stuck to the end of the cryo-probe. Due to the rapid cooling the microvasculature around the biopsy site go into vasospasm and reduces bleeding despite a large biopsy sample being acquired.

Cryotherapy has been used in the airway since 1968. The ability to use this method while the patient is using high flow oxygen as well as being a cheap equipment to use makes it very affordable and useful equipment in any interventional bronchoscopy unit. Most bronchoscopists will be trained and familiar with cryo biopsy technique.

The cryo-biopsies were compared against forceps biopsies in this study and demonstrated larger sample size and less crush artefact favouring cryo- biopsy use.

The most encouraging results published recently was looking at cryo-biopsy for PPL using R-EBUS guidance, which demonstrated a yield of 74% and the ability to obtain 3 times larger tissue biopsies when compared to traditional forceps biopsies. There were no pneumothorax in this cohort and only minor bleeding was recorded requiring bronchoscopy suction alone and no other intervention recorded.

However, there had been no head to head trials comparing Cryo-probe vs. the gold standard: CT-guided biopsy.

As cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence if the yield were to be non-inferior this would certainly be the preferred choice of biopsy for PPL in the future.

With regards to cost analysis it has been shown that R-EBUS guided biopsy Vs. CT guided biopsy has similar cost profiles for the procedure alone. However the final cost of the procedure depends on the side effects experienced using each procedure, making CT guided biopsy the costlier of the 2 methods.

However, cryo-biopsy and CT guided biopsy had not been compared in an economic analysis before.

Methodology All patients with a PPL requiring a diagnosis will be eligible for the trial.

Prior to the procedure: (Either CT guided biopsy or cryo biopsy)

1. The size of the lesion will be recorded (volume assessment and maximum diameter on the axial scan) from the CT scan prior to procedure. .

If the patient is randomised to the cryo biopsy arm:

1. The bronchoscopist will plan the pathway to the PPL based on the CT scans. The sub segments from which the lesions could be biopsied will be pre-determined and documented. If available, virtual bronchoscopy will be used to confirm this navigational path to the lesion.
2. Maximum time allowed to locate the lesion via R-EBUS would be 20 mins.
3. The procedure will be done under the usual guidelines and practice of the centre as for a flexible bronchoscopy procedure. As this is a multi-centre trial centre variation on the usual practice of bronchoscopy may vary.
4. Some centres may use fluoroscopy, in addition, to localise the lesion. This is also acceptable in the protocol.
5. If an endobronchial lesion is found then the patient is excluded.
6. Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is inserted covered by the GS.
7. Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.
8. The cryo probe is then inserted through the GS to the desired location. Flexible Cryo probe (outer diameter 1.9 mm) will be applied for 4 seconds for each biopsy.
9. The probe will be retracted together with the GS and the bronchoscope en masse after each biopsy.
10. A minimum of 1 and maximum of 3 samples will be taken.
11. A CXR is taken within 1-hour post procedure to access for pneumothorax.
12. Adverse events during the procedure will be recorded as: Minor bleeding (requiring cold saline or adrenalin), moderate bleeding (requiring a bronchial blocker or APC) and a large bleed (requiring blood transfusion, FFP, cardiothoracic support) etc.
13. If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required all costs will be calculated retrospectively. Minor bleeding will not be considered an additional cost as this occurs with routine bronchoscopy.

If the patient is randomised to the CT biopsy arm:

1. The interventional radiologist will decide on the best position for the patient to stay during the procedure.
2. A core biopsy will be performed as per usual practice of that centre. In CMDHB all CT guided biopsies are performed as core biopsies.
3. The patient will have 2-6 biopsies from the PPL.
4. Patient lies on the side of the biopsy for 1 hour post procedure. Post procedure monitoring will be performed as per usual practice.
5. A CXR 1 hour post procedure will be performed to assess for pneumothorax or procedure related bleeding.
6. If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required all costs will be calculated retrospectively.

At the pathology:

All samples will be assessed for area of specimen to assess the size. The ability to perform molecular typing will be documented.

An independent pathologist will assess samples

Economic analysis:

For both procedures: Both direct costs (From the hospital records) and indirect cost (by administering a patient questionnaire) will be recorded.

The main aim of cost analysis is to calculate the cost of side effect management in each arm to determine the most cost effective method of sampling a PPL.

Comparing Diagnostic Yield Between R-EBUS Guided Cryo Biopsy Vs. CT Guided Biopsy for PPL

Randomised Controlled Trial Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound (R-EBUS) Guided Cryo-biopsy Vs. CT-guided Transthoracic Biopsy in Patients With Parenchymal Lung Lesion, Suspected of Lung Cancer (CT-CROP)

This outcome measures the efficacy of CT guided biopsy (The current Gold standard) against the new biopsy method called cryo-biopsy which has better safety profile from previous pilot studies.

The CT guided biopsy has good efficacy rates but a high risk of pneumothorax (up to 30%) and pulmonary haemorrhage (4-27%), which requires further management adding to the cost of the intervention. The cryobiopsy method had been proven in pilot studies to have a better safety profile with \<1% pneumothorax risk. Hence comparing the side effect profile and if cryo biopsy is far safer alternative would make this the first option for the patient.

Cryo biopsy gives a larger sample size and hypothesized to give a better molecular analysis for EGFR mutation and ALK mutation analysis

Middlemore Hospital, New Zealand

Respiratory Physician, Intervetional bronchoscopist

The same needle gauge will be used for these participant to acquire the initial diagnosis on ROSE (either 21 or 22G). Using standard sampling techniques, the mass or LN will be penetrated with the needle as confirmed by ultrasound, and the needle will be passed back from the proximal to the distal ends of the node to obtain the samples for an adequate cell block. The minimum number of cell passes to obtain a cell block will be set at three.

The operator will switch to a flexible, single-use, 1.1 mm cryoprobe (Erbe 20402-401, Erbe, Tübingen, Germany) for these participants to obtain cryobiopsies. The operator will introduce the probe into the working channel of the EBUS bronchoscope. The cryoprobe will then be advanced toward the puncture site and inserted gently through the previous puncture site created by the initial EBUS-TBNA needle. The operator will confirm the placement of the probe via the EBUS image, and photo capture will be done. The cryo-probe will be activated and cooled for 3 seconds before retracting with the bronchoscope with the frozen biopsy tissue attached to the tip. The minimum number of freeze attempts to obtain a cell block will be set at three.

Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

Endobronchial ultrasound with transbronchial needle aspiration

Bronchoscopy

Vanderbilt-Ingram Services for Timely Access

Vanderbilt-Ingram Service Services for Timely Access

Fabien Maldonado, MD

This is a multi-center, clinical trial evaluating the effect of adding transbronchial mediastinal cryobiopsy to EBUSTBNA for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or acquisition of tissue for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE of a mediastinal 8 lymph node or mass suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a transbronchial mediastinal cryobiopsy.

Primary Objective:

- To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS).

Safety Endpoints:

* Pneumothorax within 7 days of procedure
* Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine
* Serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability
* Respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure
* Unplanned hospitalization related to the procedure within 7 days of procedure
* Death

Exploratory Endpoints:

* Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
* Proportion of samples that are adequate for complete NGS library sequencing
* Estimated total number of tumor cells per H\&E-stained slide
* Histological disease subtyping

TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

A Multicenter Randomized Trial of EBUS-TBNA Versus EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing the META-Gen Study

Comparison of samples between arms that meet sufficiency criteria for NGS

Comparison of samples between arms that meet PD-1/PD-L1 adequacy

Comparison of samples between arms that meet sufficiency criteria and then are adequate for complete NGS library sequencing

Comparison of samples between arms of estimated tumor cells per H\&E-stained field

Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic)

Vanderbilt-Ingram Cancer Center

Professor of Medicine

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

All study participants will undergo transbronchial biopsies via our proposed standardized cryo-biopsy protocol in place of the traditional forceps transbronchial biopsy that is typically used at MSK.

After enrollment, and pre-treatment procedures are complete, patients will undergo flexible bronchoscopy with a therapeutic bronchoscope under general anesthesia via an advanced airway at Memorial Hospital in an inpatient or outpatient setting.

Transbronchial cryobiopsy

Bryan Husta, MD

The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.

This is a single center investigator initiated study for patients who display indeterminant pulmonary nodules and diffuse parenchymal lung disease on CT chest imaging who have been referred to the Pulmonary service.

Safety of Lung Cryobiopsy in People With Cancer

Safety of Transbronchial Cryobiopsy in a Cancer Population

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)

Memorial Sloan Kettering Cancer Center

Infections

Symptoms and General Pathology

Tuberculosis

Pleural Effusion

Pleurisy

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Pleural Diseases

Respiratory Tract Infections

Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).

Cryoprobe pleural biopsy first

Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)

Flexible forceps biopsy first

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:

Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study

The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

Size of biopsy specimens obtained with the two techniques

Time taken for the procedure with the two techniques

Ease of taking biopsy with the two techniques assessed using a visual analog scale

Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe

Depth of the tissue obtained on histopathology

Number of participants with bleeding seen while taking biopsy categorised into "no bleeding", "minimal self limited ooze", "bleeding requiring prolonged suctioning" , "major hemorrhage requiring blood transfusion, causing hemodynamic instability or ICU admission"

Post Graduate Institute of Medical Education and Research, Chandigarh

Assistant Professor

Patients, whose transbronchial forceps biopsy was performed

Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well

All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and mini probe endobronchial ultrasound (RP-EBUS) scans were enrolled. Transbronchial forceps biopsy (TBFB) was performed for all these patients.

Transbronchial forceps biopsy

All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans were enrolled. TBFB was performed for all these patients. In addition, all of these patients, with no contraindications, underwent transbronchial cryobiopsy (TBCB)

Transbronchial forceps biopsy+Transbronchial cryobiopsy

This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC	NCT03971175	Carcinoma, Non-... Pathology, Mole...	Forceps biopsy Cryobiopsy	18 Years -	University Hospital Tuebingen
Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy	NCT06120829	Cryobiopsy of P...	Cryobiopsy Cryobiopsy Core Needle Bio...	18 Years - 89 Years	San Antonio Uniformed Services Health Education Consortium
Comparing Diagnostic Yield Between R-EBUS Guided Cryo Biopsy Vs. CT Guided Biopsy for PPL	NCT02395939	Lung Cancer	CT guided core ... Cryo-biopsy via...	18 Years -	Middlemore Hospital, New Zealand
Comparing Diagnostic Yield Between R-EBUS Guided Cryo Biopsy Vs. CT Guided Biopsy for PPL	NCT02395939	Lung Cancer	CT guided core ... Cryo-biopsy via...	18 Years -	Middlemore Hospital, New Zealand
TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing	NCT06105801	Lung Cancer	Endobronchial u... Bronchoscopy Cryobiopsy	18 Years -	Vanderbilt-Ingram Cancer Center
Safety of Lung Cryobiopsy in People With Cancer	NCT04548830	Lung Cancer	Transbronchial ...	18 Years -	Memorial Sloan Kettering Cancer Center
Safety of Lung Cryobiopsy in People With Cancer	NCT04548830	Lung Cancer	Transbronchial ...	18 Years -	Memorial Sloan Kettering Cancer Center
Comparing Diagnostic Yield Between R-EBUS Guided Cryo Biopsy Vs. CT Guided Biopsy for PPL	NCT02395939	Lung Cancer	CT guided core ... Cryo-biopsy via...	18 Years -	Middlemore Hospital, New Zealand
TBNA vs EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing	NCT06105801	Lung Cancer	Endobronchial u... Bronchoscopy Cryobiopsy	18 Years -	Vanderbilt-Ingram Cancer Center
Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy	NCT06120829	Cryobiopsy of P...	Cryobiopsy Cryobiopsy Core Needle Bio...	18 Years - 89 Years	San Antonio Uniformed Services Health Education Consortium
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy	NCT02500277	Pleural Effusio... Pleurisy Tuberculosis Metastatic Mali...	Cryoprobe pleur... Flexible forcep...	12 Years - 79 Years	PGIMER
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer	NCT05164445	Lung Cancer	Transbronchial ... Transbronchial ...	18 Years - 90 Years	Lithuanian University of Health Sciences

Spots Global Cancer Trial Database for cryobiopsy

Every month we try and update this database with for cryobiopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cryobiopsy

Every month we try and update this database with for cryobiopsy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cryobiopsy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.