1. To compare the need for (prolonged) chest tube drainage in two different diagnostic strategies to acquire lung tissue in ILD (bronchoscopic cryobiopsy followed on indication by surgical lung biopsy (intervention) versus immediate surgical lung…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(prolonged) need for chest tube drainage
Secondary outcome
complications, comprehensive complication index, in hospital stay, days with
chest tube, pain and pain medication use, health related quality of life,
diagnostic yield and diagnostic confidence per diagnostic strategy and
procedure, patient preference and health care costs.
Background summary
Assessing an accurate diagnosis of interstitial lung disease (ILD) can be
challenging. In case of a need for tissue verification following HRCT, surgical
lung biopsy (SLB) is indicated. Diagnostic yield of SLB is high (>90%) however,
invasive and associated with significant morbidity, complications and health
care utilisation. Transbronchial cryobiopsy (TBCB) is a recently developed
bronchoscopic procedure; its diagnostic yield is lower (75%), but TBCB might be
an attractive first step diagnostic approach for being considerably less
invasive than SLB. Due to the absence of prospective studies between TBCB and
SLB the optimal diagnostic strategy for tissue acquisition in ILD is currently
unknown.
Study objective
1. To compare the need for (prolonged) chest tube drainage in two different
diagnostic strategies to acquire lung tissue in ILD (bronchoscopic cryobiopsy
followed on indication by surgical lung biopsy (intervention) versus immediate
surgical lung biopsy (current standard))
2. To register and describe adverse events associated with the two different
diagnostic strategies to acquire lung tissue in ILD in surgical candidates; 3.
To asses compare patient- and healthcare burden of the two different diagnostic
strategies for tissue acquisition in ILD patients;
4. To asses complications, patient- and healthcare burden among patients who
are unfit to undergo surgical lung biopsy and receive cryobiopsy instead.
Study design
Randomized controlled trial
Intervention
Randomization between transbronchial cryobiopsy (followed by surgical biopsy in
case of inconclusive results) versus immediate surgical biopsy.
Study burden and risks
Participants will be asked to complete EQ-5D-5L questionnaires and VAS pain
questionnaires at regular intervals during follow-up and iMCQ and iPCQ
questionnaires adjusted to the study setting at the end of follow-up. In the
diagnostic strategy with step up approach it is to be expected that in 3 out of
4 participants a surgical procedure will be prevented, as a diagnosis is
provided by TBCB. However, participants with inconclusive TBCB results will
have to undergo a subsequent surgical lung biopsy.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
interstitial lung disease based on HR-CT scan and a ILD-multidisciplinary
discussion panel decides there is a need for lungbiopsy.
Exclusion criteria
Inability and willingness to provide informed consent, Inability to comply with
study protocol, Use of carbasalate calcium, clopidogrel, or other new
anti-platelet therapy that cannot be stopped temporarily, Thrombocytopenia <
50x10^9/L, Pregnancy, History of pulmonary hypertension (systolic pulmonary
artery pressure > 50 mmHg), Diffusing capacity < 30%, Forced vital capacity
<50% * Forced expiratory volume in the first second (FEV1) <0,8L or <50% of
predicted value, Body mass index > 35 * Hypoxemia, PaO2 < 60 mmHg on room air /
while receiving 2L per minute on nasal oxygen
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66993.018.18 |