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"Bronchoscopy - methods"
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Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules
2025
Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography-guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear.
In this multicenter, randomized, parallel-group, noninferiority trial, we assigned patients with an intermediate-risk or high-risk peripheral pulmonary nodule measuring 10 to 30 mm in diameter to undergo navigational bronchoscopy or transthoracic needle biopsy at seven centers across the United States. The primary outcome was diagnostic accuracy, which was defined as the percentage of patients with biopsies that showed a specific diagnosis (cancer or a specific benign condition) that was confirmed to be accurate through 12 months of clinical follow-up (nonferiority margin, 10 percentage points). Secondary outcomes included procedural complications such as the occurrence of pneumothorax.
Among the 234 patients included in the primary-outcome analysis (5 of whom were lost to follow-up), biopsy resulted in a specific diagnosis that was confirmed to be accurate through month 12 in 94 of 119 patients (79.0%) in the navigational bronchoscopy group and in 81 of 110 patients (73.6%) in the transthoracic needle biopsy group (absolute difference, 5.4 percentage points; 95% confidence interval, -6.5 to 17.2; P = 0.003 for noninferiority; P = 0.17 for superiority). Pneumothorax occurred in 4 of 121 patients (3.3%) in the navigational bronchoscopy group and in 32 of 113 patients (28.3%) in the transthoracic needle biopsy group and led to the placement of a chest tube, hospital admission, or both in 1 patient (0.8%) and 13 patients (11.5%), respectively.
The diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic needle biopsy among patients with peripheral pulmonary nodules measuring 10 to 30 mm. (Funded by Medtronic and others; VERITAS ClinicalTrials.gov number, NCT04250194.).
Journal Article
Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial
by
Hansell, David M
,
Zoumot, Zaid
,
Jordan, Simon
in
Aged
,
Bronchoscopy - methods
,
Chronic obstructive pulmonary disease
2015
Lung volume reduction surgery improves survival in selected patients with emphysema, and has generated interest in bronchoscopic approaches that might achieve the same effect with less morbidity and mortality. Previous trials with endobronchial valves have yielded modest group benefits because when collateral ventilation is present it prevents lobar atelectasis.
We did a single-centre, double-blind sham-controlled trial in patients with both heterogeneous emphysema and a target lobe with intact interlobar fissures on CT of the thorax. We enrolled stable outpatients with chronic obstructive pulmonary disease who had a forced expiratory volume in 1 s (FEV1) of less than 50% predicted, significant hyperinflation (total lung capacity >100% and residual volume >150%), a restricted exercise capacity (6 min walking distance <450 m), and substantial breathlessness (MRC dyspnoea score ≥3). Participants were randomised (1:1) by computer-generated sequence to receive either valves placed to achieve unilateral lobar occlusion (bronchoscopic lung volume reduction) or a bronchoscopy with sham valve placement (control). Patients and researchers were masked to treatment allocation. The study was powered to detect a 15% improvement in the primary endpoint, the FEV1 3 months after the procedure. Analysis was on an intention-to-treat basis. The trial is registered at controlled-trials.com, ISRCTN04761234.
50 patients (62% male, FEV1 [% predicted] mean 31·7% [SD 10·2]) were enrolled to receive valves (n=25) or sham valve placement (control, n=25) between March 1, 2012, and Sept 30, 2013. In the bronchoscopic lung volume reduction group, FEV1 increased by a median 8·77% (IQR 2·27–35·85) versus 2·88% (0–8·51) in the control group (Mann-Whitney p=0·0326). There were two deaths in the bronchoscopic lung volume reduction group and one control patient was unable to attend for follow-up assessment because of a prolonged pneumothorax.
Unilateral lobar occlusion with endobronchial valves in patients with heterogeneous emphysema and intact interlobar fissures produces significant improvements in lung function. There is a risk of significant complications and further trials are needed that compare valve placement with lung volume reduction surgery.
Efficacy and Mechanism Evaluation Programme, funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.
Journal Article
Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study
2023
Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study aimed to compare the safety and efficacy of remimazolam with those of midazolam for bronchoscopy. This prospective randomized parallel-group study was conducted at a single institution. The primary outcome was the time from the end of the procedure to full alertness. Other procedural time parameters, satisfaction profiles, and adverse effects were thoroughly evaluated. The time taken to reach peak sedation and the time from the end of the procedure to full alertness was significantly shorter in the remimazolam group than in the midazolam group (median [interquartile range], 2 min [1–4] vs. 3 min [2–5],
P
= 0.006; and median, 2 min [1–5] vs. 5 min [1–12],
P
= 0.035, respectively). In patients with non-biopsy procedures (n = 79), participant satisfaction was significantly higher in the remimazolam group than in the midazolam group (median rated scale, 10 vs. 7,
P
= 0.042). Physician satisfaction and willingness to repeat the procedure were similar between groups. Although the incidence of adverse effects was similar between the groups and there was no significant difference, the midazolam group had a higher antidote administration rate than the remimazolam group (15.7% vs. 4.1%,
P
= 0.092). Remimazolam is effective and safe for achieving adequate sedation, with a shorter onset time and faster neuropsychiatric recovery than midazolam. It may be a new option for sedation during bronchoscopy.
Trial registration
: The trial registration number is NCT05994547, and the date of first registration is 16/08/2023.
Journal Article
Efficacy and safety of remimazolam versus dexmedetomidine for patients undergoing flexible fiberoptic bronchoscopy: A randomized, clinical trial
2024
Remimazolam's benefits for patients undergoing painless flexible fiberoptic bronchoscopy remain uncertain. We aimed to compare the efficacy and safety of remimazolam and dexmedetomidine in flexible fiberoptic bronchoscopy (FFB).
Randomized controlled trial.
University hospital.
Between April 2021 and September 2022, patients undergoing painless flexible fiberoptic bronchoscopy were recruited.
The patients were randomly assigned with a 1:1 ratio to remimazolam-remifentanil group (RR group) or dexmedetomidine-remifentanil group (DR group).
The primary outcome was the procedure interruption rate during bronchoscopy. Secondary outcomes were hemodynamic changes, resuscitation time, rescue medication usage rate and dose, satisfaction scores of patients and bronchoscopists, operation-related complications, and adverse events.
A total of 363 patients were included for final analysis. The interruption rates of bronchoscopy were 8.2 % in the RR group and 39.2 % in the DR group (P < 0.05). The rescue medication usage rate (4.4 % vs. 38.7 %, P < 0.05) and dose (1.51 ± 8.15 mg vs. 13.17 ± 18.86 mg, P < 0.05) were lower in the RR group compared with the DR group. The incidence of oxygen desaturation was significantly lower in the RR group than in the DR group (14.3 % vs. 44.2 %, P < 0.05). Hemodynamic changes in patients in the DR group were significant, with longer recovery time and lower satisfaction scores for both inpatients and bronchoscopists (P < 0.05), compared with the RR group. However, there were no significant differences between groups in terms of operation-related complications (P > 0.05) except for postoperative dizziness, which was more common in the DR group (P < 0.05).
Remimazolam is effective and safe in painless flexible fiberoptic bronchoscopy. It allows a lower procedure interruption rate and incidence of oxygen desaturation, providing better hemodynamic stability compared to dexmedetomidine.
•Remimazolam, an ultra-short-acting benzodiazepine, induced better sedation during bronchoscopy than dexmedetomidine.•Remimazolam had a better safety profile than that of dexmedetomidine.•Remimazolam anesthesia had higher bronchoscopist and patient satisfaction score.
Journal Article
Virtual Bronchoscopic Navigation Combined with Ultrathin Bronchoscopy. A Randomized Clinical Trial
2013
Abstract
Rationale
In bronchoscopy, an ultrathin bronchoscope can be advanced to more peripheral bronchi. Because virtual bronchoscopic navigation (VBN) is a method to guide a bronchoscope under direct observation using VB images, VBN may be particularly useful when combined with ultrathin bronchoscopy.
Objectives
This prospective multicenter study evaluated the value of VBN-assisted ultrathin bronchoscopy for diagnosing peripheral pulmonary lesions.
Methods
We randomly assigned 350 patients with peripheral pulmonary lesions (diameter, ≤30 mm) to VBN-assisted or non–VBN-assisted groups. An ultrathin bronchoscope (outer diameter, 2.8 mm) was introduced to the target bronchus using a VBN system in the VBN-assisted group, whereas only computed tomography axial images were referred to in the non–VBN-assisted group. Specimen sampling sites were verified using X-ray fluoroscopy.
Measurements and Main Results
Subjects for analysis included 334 patients. There was no significant difference in the diagnostic yield between the VBN-assisted group (67.1%) and the non–VBN-assisted group (59.9%; P = 0.173). The subgroup analysis showed that the diagnostic yield was significantly higher in the VBN-assisted group than in the non–VBN-assisted group for right upper lobe lesions (81.3% vs. 53.2%; P = 0.004); lesions invisible on posterior–anterior radiographs (63.2% vs. 40.5%; P = 0.043); and lesions in the peripheral third of the lung field (64.7% vs. 52.1%; P = 0.047).
Conclusions
VBN-assisted ultrathin bronchoscopy does not improve the diagnostic yield for peripheral pulmonary lesions. However, the method improves the diagnostic yield for lesions in the subcategories (right upper lobe, invisible, peripheral third), warranting further study.
Clinical trial registered with www.umin.ac.jp/ctr/ (UMIN 000001536).
Journal Article
Disposcope endoscope guidance versus fiberoptic bronchoscopy guidance for double-lumen tube intubation in patients undergoing thoracic surgery: a randomized controlled non-inferiority trial
2025
Double-lumen tube (DLT) intubation is frequently performed for thoracic surgery, and a fiberoptic bronchoscopy (FOB) can improve the success rate of correct placement. Disposcope endoscope-guided DLT intubation was recently introduced and has a high first-attempt success rate. We tested whether compared with FOB-guided DLT intubation, disposcope endoscope-guided DLT intubation results in a non-inferior first-attempt success rate. A total of 181 patients who underwent thoracic surgery and required DLT intubation were randomly assigned to two groups: FOB guidance (FOB group) and disposcope endoscope guidance (DE group). The primary outcome was the first-attempt success rate. The secondary outcomes included the number of attempts, first intubation time, intraoperative dislodgement, and changes in the mean arterial pressure (MAP) and heart rate (HR) after intubation. The difference in the first DLT attempt success rate between the groups did not exceed the non-inferiority margin of 8% (DE group: 91.3% vs. FOB group: 89.9%; difference: 1.4%, 95% exact CI: −7.1–9.9%). The difference in the number of multiple DLT attempts also did not differ between the DE group and the FOB group (two attempts: 6.5% vs. 6.7%,
P
= 0.953; three attempts: 2.2% vs. 3.4%,
P
= 0.120). The first DLT intubation time [66 (55–86) vs. 77 (64–98) s,
P
= 0.010] was significantly shorter in the DE group. No significant differences were observed in the intraoperative dislodgement or changes in the MAP or HR after intubation (
P
> 0.05). Compared with FOB guidance, disposcope endoscope guidance provided a non-inferior first-attempt success rate and a shorter first intubation time for DLT intubation.
Journal Article
Transbronchial Lung Cryobiopsy in Diffuse Parenchymal Lung Disease: Comparison between Biopsy from 1 Segment and Biopsy from 2 Segments - Diagnostic Yield and Complications
2017
Background: Transbronchial lung cryobiopsy is an innovative method of obtaining samples from the parenchyma of patients with diffuse parenchymal lung diseases. However, the technique is not yet standardized, and uncertainty exists about the optimal protocol, including the number of samples, the biopsy size, and the choice of the biopsy site. Objectives: To compare the diagnostic yield and complications of cryobiopsy with different strategies adopted to sample lung tissue (number of samples, biopsy site, and sample size). Methods: We prospectively enrolled 46 patients with suspected diffuse parenchymal lung diseases for the diagnosis of which a biopsy was deemed useful. All patients underwent transbronchial lung cryobiopsy, and they were randomly assigned to group A (4 samples obtained from the same segment) or group B (2 samples obtained from one segment and 2 samples obtained from a different segment of the same lobe). Analysis of the samples was performed sequentially (from the first to the last sample), and pathologists reformulated their histopathologic diagnosis with the addition of each sample. Results: The mean diagnostic yield of the procedure combining the 2 groups and performing only the first sampling was 69%. When a second biopsy was performed as well, the mean diagnostic yield improved, but this increase was significant only when the 2 samples were obtained from 2 different segments (96%, group B). Conclusions: This study suggests that the strategy of performing 2 biopsies with a cryoprobe may be associated with an increased diagnostic yield in diffuse parenchymal lung diseases if these samples are obtained from 2 different segments within the same lobe.
Journal Article
Virtual bronchoscopic navigation combined with endobronchial ultrasound to diagnose small peripheral pulmonary lesions: a randomised trial
2011
BackgroundBronchoscopy using endobronchial ultrasound (EBUS) can help to diagnose small peripheral pulmonary lesions. However, although biopsy sites can be confirmed, a bronchoscope cannot be guided in EBUS. Virtual bronchoscopic navigation (VBN) can guide a bronchoscope with virtual images, but its value has not been confirmed.MethodsThis prospective multicentre study examines the value of VBN-assisted EBUS for diagnosing small peripheral pulmonary lesions. 199 patients with small peripheral pulmonary lesions (diameter ≤30 mm) were randomly assigned to VBN-assisted (VBNA) or non-VBN-assisted (NVBNA) groups. A bronchoscope was introduced into the target bronchus of the VBNA group using the VBN system. Sites of specimen sampling were verified using EBUS with a guide sheath under fluoroscopy.ResultsThe diagnostic yield was higher for the VBNA than for the NVBNA group (80.4% vs 67.0%; p=0.032). The duration of the examination and time elapsed until the start of sample collection were reduced in the VBNA compared with the NVBNA group (median (range), 24.0 (8.7–47.0) vs 26.2 (11.6–58.6) min, p=0.016) and 8.1 (2.8–39.2) vs 9.8 (2.3–42.3) min, p=0.045, respectively). The only adverse event was mild pneumothorax in a patient from the NVBNA group.ConclusionsThe diagnostic yield for small peripheral pulmonary lesions is increased when VBN is combined with EBUS.Clinical trial numberUMIN000000569.
Journal Article
Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules
2015
Introduction The promise of benefits from lung cancer screening is tempered by the false positive rate and the need to perform diagnostic procedures to determine the aetiology of the solitary pulmonary nodules (SPN) identified. We have developed a novel procedure which allows sampling of SPNs via a transparenchymal approach, and report the results from this as a first in human trial. Methods This study was a prospective single-arm interventional study. We recruited patients with a SPN detected on CT imaging, which was suspicious for lung cancer, who were suitable for surgical resection. Using the subject's CT, an optimal airway wall point of entry (POE), and an avascular path through lung tissue from the POE to the SPN was calculated. A tunnel tract was created from the POE to the nodule using a set of catheter-based tools under fused fluoroscopy guidance. The patients proceeded to surgical resection immediately after the biopsy. The participants were followed-up for 6 months after the procedure. The primary endpoint of the study was to evaluate the feasibility to access and biopsy the nodule. Results Twelve patients were recruited, and a tunnel pathway created in 10 patients. There were no adverse events during the procedures. Adequate biopsies were obtained from 10 patients (83%), which correlated with the histological findings from the surgical resection. Inspection of the resected lobes did not raise any safety concerns and indicated appropriately tunnelled pathways to the nodule. Conclusions This first in human study demonstrates that bronchoscopic transparenchymal access of SPNs is feasible. Trial registration number NCT02130115.
Journal Article
Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial
2025
Robotic assisted bronchoscopy (RAB) and electromagnetic navigational bronchoscopy (ENB) are two approaches to biopsy peripheral pulmonary lesions (PPLs). A recently completed cluster randomized controlled trial, RELIANT (NCT05705544), showed no difference in diagnostic yield between these two modalities. The ENB platform used in RELIANT included integrated digital tomosynthesis, allowing for real-time assessment of PPL location for more precise targeting at the time of biopsy. RAB has since been integrated with cone beam computed tomography (CBCT) to accomplish the same intraprocedural correction. It is unclear if the diagnostic yield of RAB with integrated CBCT (RAB-CBCT) is superior to ENB with integrated digital tomosynthesis (ENB-DT).
Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT using integrated intraprocedural imaging (RELIANT 2) is an investigator-initiated, multicenter, open label, superiority, cluster randomized trial. At each participating institution, procedural rooms are randomly assigned to either RAB-CBCT or ENB-DT, with each procedure room-day considered a cluster. All adult patients undergoing navigational bronchoscopy for evaluation of PPL(s) are eligible. Allocation is concealed from schedulers, proceduralists, and patients until the morning of procedure when each room is randomized to a platform. The primary endpoint is the diagnostic yield, defined as the proportion of cases yielding a specific benign or malignant diagnosis per current ATS/ACCP definition. Secondary and safety endpoints include procedure duration and procedural complications. Enrollment began on November 11, 2024 and is expected to enroll approximately 440 patients in 220 clusters.
RELIANT 2 is an ongoing cluster randomized trial comparing the diagnostic yield of RAB-CBCT to that of ENB-DT in patients undergoing bronchoscopy to biopsy PPLs. This trial will help address some of the limitations of the recently published RELIANT trial. Trial registration The trial was registered in ClinicalTrials.gov (NCT06654271) on October 21, 2024, prior to patient enrollment.
Journal Article