SarcoidosisNCT02405897
A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis
A study testing Cup forceps and Alligator forceps in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves multiple body organs. The diagnosis requires the presence of compatible clinicoradiological features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph nodes and the lung parenchyma are the most… Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Cup forceps and Alligator forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a clinical diagnosis of sarcoidosis undergoing flexible bronchoscopy
- age group of 12 to 90 years;
- hemodynamically stable (systolic BP > 100 mm Hg without the need of vasopressors); and
- ability to provide informed consent to participate in the study.
Who cannot join
- hemoglobin less than 8 gm/dL;
- platelet count of less than 80000;
- bleeding diathesis;
- prothrombin time or activated partial thrombin time prolongation of more than 6 seconds when compared to control;
- baseline room air saturation less than 90%;
- pregnancy; and,
- failure to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves multiple body organs. The diagnosis requires the presence of compatible clinicoradiological features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that can be sampled by, performing various bronchoscopic techniques. In a recent study the use of alligator forceps had a better yield in comparison to cup forceps. The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.
Read the detailed description
Sarcoidosis is a multisystem disorder characterized by granulomatous inflammation involving various body organs. The diagnosis is based on presence of fulfillment of compatible clinicoradiological features and histologic evidence of non-caseating granuloma after exclusion of other known causes for granulomatous inflammation.1 As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, performing various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling. The diagnostic yield of TBLB in sarcoidosis in stage I and II varies from 31%2 to 69.6%.3 Transbronchial lung biopsy (TBLB) is performed with flexible bronchoscopy under the effect of local anesthesia and is the most commonly used bronchoscopic procedure to diagnose a wide array of lung diseases. It is performed as an outpatient procedure and is associated with minimal complications such as bleeding, pneumothorax and others.4 The procedure can be performed either as a blindly or under fluoroscopic guidance. The yield of TBLB varies depending upon the extent of disease, size of tissue, number of alveoli, number of biopsies, whether the sample floats or not and the size of forceps.5-12 The diagnostic yield of TBLB in sarcoidosis depends on the radiological stage and varies from 50-65% in stage I to 80 to 85% in stage II.13-15 The diagnostic yield also depends on the number of biopsy specimens (ten in stage I and 4-6 in stage II and III).9,10 In a recent study comprising of 44 patients with 176 samples, the use of alligator forceps yielded larger samples with lesser incidence of complications (major bleeding, alligator v/s cup forceps respectively, 1% v/s 5.7% and pneumothorax, 4.5 %v/s 9.1%). The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- Cup forceps, Alligator forceps
- Keywords
- flexible bronchoscopy, transbronchial lung biopsy, forceps
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cup forcepsDevice
In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps
Alligator forcepsDevice
In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps
| Study group | Role | What they receive |
|---|---|---|
| Cup forceps | Experimental | 4 biopsies (transbronchial lung biopsy) with Cup forceps Receives: Device: Cup forceps |
| Alligator forceps | Active comparator | 4 biopsies (transbronchial lung biopsy) with Alligator forceps Receives: Device: Alligator forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Size of tissue: Size of the tissue will be visually assessed as small if it does not fill the cup, medium if it fills the cup and large if comes out of the cup
Measured: 12 months
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Size of tissue in millimeters during histopathology
Measured: 12 months
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)
Histopathology examination and findings
Measured: 12 months
Secondary outcomes (2)
Complication (Occurrence of bleeding)
Occurrence of bleeding
Measured: 12 months
Complication (Occurrence of pneumothorax)
Occurrence of pneumothorax
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ritesh Agarwal, MD, DM, Principal investigator, PGIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405897
- Sponsor's protocol ID
- 0810
- Status last verified
- Jan 2017
- First submitted
- 23 Mar 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT02405897
- Acronym / sponsor ID
- 0810
- Conditions
- Sarcoidosis
- Keywords
- flexible bronchoscopy, transbronchial lung biopsy, forceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves multiple body organs. The diagnosis requires the presence of compatible clinicoradiological features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that can be sampled by, performing various bronchoscopic techniques. In a recent study the use of alligator forceps had a better yield in comparison to cup forceps. The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.
Detailed description
Sarcoidosis is a multisystem disorder characterized by granulomatous inflammation involving various body organs. The diagnosis is based on presence of fulfillment of compatible clinicoradiological features and histologic evidence of non-caseating granuloma after exclusion of other known causes for granulomatous inflammation.1 As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, performing various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling. The diagnostic yield of TBLB in sarcoidosis in stage I and II varies from 31%2 to 69.6%.3 Transbronchial lung biopsy (TBLB) is performed with flexible bronchoscopy under the effect of local anesthesia and is the most commonly used bronchoscopic procedure to diagnose a wide array of lung diseases. It is performed as an outpatient procedure and is associated with minimal complications such as bleeding, pneumothorax and others.4 The procedure can be performed either as a blindly or under fluoroscopic guidance. The yield of TBLB varies depending upon the extent of disease, size of tissue, number of alveoli, number of biopsies, whether the sample floats or not and the size of forceps.5-12 The diagnostic yield of TBLB in sarcoidosis depends on the radiological stage and varies from 50-65% in stage I to 80 to 85% in stage II.13-15 The diagnostic yield also depends on the number of biopsy specimens (ten in stage I and 4-6 in stage II and III).9,10 In a recent study comprising of 44 patients with 176 samples, the use of alligator forceps yielded larger samples with lesser incidence of complications (major bleeding, alligator v/s cup forceps respectively, 1% v/s 5.7% and pneumothorax, 4.5 %v/s 9.1%). The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cup forceps | Experimental | Device: Cup forceps4 biopsies (transbronchial lung biopsy) with Cup forceps |
| Alligator forceps | Active comparator | Device: Alligator forceps4 biopsies (transbronchial lung biopsy) with Alligator forceps |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a clinical diagnosis of sarcoidosis undergoing flexible bronchoscopy
- age group of 12 to 90 years;
- hemodynamically stable (systolic BP > 100 mm Hg without the need of vasopressors); and
- ability to provide informed consent to participate in the study.
Key exclusion criteria (7 listed)
- hemoglobin less than 8 gm/dL;
- platelet count of less than 80000;
- bleeding diathesis;
- prothrombin time or activated partial thrombin time prolongation of more than 6 seconds when compared to control;
- baseline room air saturation less than 90%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cup forcepsIn patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps | Device | Cup forceps |
| Alligator forcepsIn patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps | Device | Alligator forceps |
Primary outcome
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Time frame: 12 months
Size of tissue: Size of the tissue will be visually assessed as small if it does not fill the cup, medium if it fills the cup and large if comes out of the cup
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Time frame: 12 months
Size of tissue in millimeters during histopathology
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)
Time frame: 12 months
Histopathology examination and findings
2 secondary outcomes
Complication (Occurrence of bleeding)
Time frame: 12 months
Complication (Occurrence of pneumothorax)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritesh Agarwal, MD, DM principal investigator
PGIMER, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cup forceps and Alligator forceps in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.