Pleural EffusionCOFFEENCT02500277

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

A study testing Cryoprobe pleural biopsy first and Flexible forceps biopsy first in people with Pleural Effusion and Pleurisy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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 Read more about this study

Who is it for?: Ages 12 to 79 years
Conditions the study is for: Pleural Effusion, Pleurisy, Tuberculosis
What is being tested?: Cryoprobe pleural biopsy first and Flexible forceps biopsy first
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteIndia
Study dates: Jan 2015to Jul 2018
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 79 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age ≥12 years
Semirigid thoracoscopy being performed for diagnosis of the pleural effusion

Who cannot join

Age ≥80 years
SpO2 <88% on room air
Hemodynamic instability
Myocardial infarction or unstable angina in the last 6 wk
Lack of pleural space due to adhesions
Uncorrected coagulopathy
Failure to provide informed consent

Trial locations and contacts

1 site in 1 country.

India1 site

PGIMER
Chandigarh, 160012

Other trials in India

About this study

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

Read the detailed description

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.

Conditions: Pleural Effusion, Pleurisy, Tuberculosis, Metastatic Malignancy
Being tested: Cryoprobe pleural biopsy first, Flexible forceps biopsy first
Keywords: thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy
Medical subject headings: Pleural Effusion, Pleurisy, Tuberculosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cryoprobe pleural biopsy firstDevice
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).
Flexible forceps biopsy firstDevice
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)

Study groups in NCT02500277
Study group	Role	What they receive
Cryobiopsy	Active comparator	Pleural biopsy with a flexible cryoprobe Receives: Device: Cryoprobe pleural biopsy first
Forceps biopsy	Active comparator	Pleural biopsy with a flexible forceps Receives: Device: Flexible forceps biopsy first

What is being measured

The primary outcome is the main question the study is designed to answer.

Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy
Measured: One week

Secondary outcomes (6)

Biopsy size
Size of biopsy specimens obtained with the two techniques
Measured: One day
Duration of procedure
Time taken for the procedure with the two techniques
Measured: One day
Ease of biopsy VAS
Ease of taking biopsy with the two techniques assessed using a visual analog scale
Measured: One day
Artifacts
Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe
Measured: One day
Tissue depth
Depth of the tissue obtained on histopathology
Measured: One day
Bleeding
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"
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2018

First posted16 Jul 2015 (estimated)
Study startJan 2015
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pleural EffusionStudies 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: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02500277
Sponsor's protocol ID: NK/1815/Res/2439
Acronym: COFFEE
Status last verified: Aug 2018
First submitted: 13 Jul 2015
Last updated: 31 Aug 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion

All Pleural Effusion trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study
ClinicalTrials.gov ID: NCT02500277
Acronym / sponsor ID: COFFEE / NK/1815/Res/2439
Conditions: Pleural Effusion, Pleurisy, Tuberculosis, Metastatic Malignancy
Keywords: thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
Study start: Jan 2015
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 16 Jul 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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cryobiopsy	Active comparator	Device: Cryoprobe pleural biopsy firstPleural biopsy with a flexible cryoprobe
Forceps biopsy	Active comparator	Device: Flexible forceps biopsy firstPleural biopsy with a flexible forceps

Who may qualify

Ages: 12 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Age ≥12 years
Semirigid thoracoscopy being performed for diagnosis of the pleural effusion

Key exclusion criteria (7 listed)

Age ≥80 years
SpO2 <88% on room air
Hemodynamic instability
Myocardial infarction or unstable angina in the last 6 wk
Lack of pleural space due to adhesions

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
Cryoprobe pleural biopsy firstFour 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).	Device	Cryobiopsy
Flexible forceps biopsy firstSix 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)	Device	Forceps biopsy

Primary outcome

Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
Time frame: One week
The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

6 secondary outcomes

Biopsy size
Time frame: One day
Duration of procedure
Time frame: One day
Ease of biopsy VAS
Time frame: One day
Artifacts
Time frame: One day
Tissue depth
Time frame: One day
Bleeding
Time frame: One day

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 31 Aug 2018.

Related trials for Pleural Effusion

Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 31 Aug 2018. 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?

Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy (time frame: One week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02500277.

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 31 Aug 2018.