
==== Front
Jpn J Clin Oncol
Jpn J Clin Oncol
jjco
Japanese Journal of Clinical Oncology
0368-2811
1465-3621
Oxford University Press

38864253
10.1093/jjco/hyae077
hyae077
Original Article
AcademicSubjects/MED00300
Franseen needle in endobronchial ultrasound-guided transbronchial needle aspiration: a phase II prospective study
https://orcid.org/0000-0001-8781-2367
Shikano Kohei Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Ikari Jun Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Nakajima Takahiro Department of General Thoracic Surgery, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan

Ota Masayuki Department of Diagnostic Pathology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Shiko Yuki Biostatistics Section, Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Naito Akira Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Abe Mitsuhiro Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Kawasaki Takeshi Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Ikeda Jun-Ichiro Department of Diagnostic Pathology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Ozawa Yoshihito Biostatistics Section, Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Suzuki Takuji Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba, Japan

Corresponding author. Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan. E-mail: shika.v.a.r.1107@gmail.com
9 2024
12 6 2024
12 6 2024
54 9 10371044
21 2 2024
29 5 2024
30 5 2024
© The Author(s) 2024. Published by Oxford University Press.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

Background

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been used to diagnose and stage lung cancer. Acquire™ Pulmonary and Expect™ Pulmonary dedicated EBUS-TBNA needles were introduced as the Franseen and Lancet needles, respectively. It is still unclear whether the Franseen or Lancet needles yield a higher quality specimen especially focusing on next-generation sequencing-based molecular testing.

Methods

A single-center, prospective study performed at the Chiba University Hospital randomly assigned patients to two groups: Group A, wherein the first and second EBUS-TBNA were performed using Lancet and Franseen needles, respectively, and Group B, wherein the first and second EBUS-TBNA were performed using Franseen and Lancet needles, respectively. Each specimen was compared and analyzed pathologically. The primary outcome was the histological tissue area except blood clot and the cellularity of each sample. We also examined the success rate of molecular testing.

Results

Twelve patients who underwent EBUS-TBNA between November 2022 and February 2023 were enrolled in this study. The tissue area of the specimens obtained by the Franseen and Lancet needles was 13.3 ± 6.4 mm2 and 10.6 ± 6.3 mm2, respectively (P = .355). The tumor cellularity in the specimens obtained using the Franseen and Lancet needles was 54.0 ± 30.3 and 46.2 ± 36.3%, respectively (P = .608). The success rate of molecular testing using the single-pass sample by Franseen needle was 85.7 and 57.1% by Lancet needle. No serious complications were reported.

Conclusions

The Franseen needle tended to show a greater amount of specimen with higher tumor cellularity than the Lancet needle which may contribute higher success rate of molecular testing. Further studies must be conducted to validate the results of this study.

Key findings

The Franseen needle tended to show a greater amount of specimen with higher tumor cellularity.

What is known and what is new? 

EBUS-TBNA has been used to diagnose and stage lung cancer.

Acquire™ Pulmonary was introduced as the Franseen needle.

What is the implication, and what should change now? 

The Franseen needle may contribute to higher success rate of molecular testing.

We assessed the usefulness of Franseen needle-dedicated endobronchial ultrasound-guided transbronchial needle aspiration and found the Franseen needle tended to show a greater amount of specimen with higher tumor cellularity.

bronchoscopy
endobronchial ultrasound (EBUS)
lung cancer
next-generation sequencing (NGS)
transbronchial needle aspiration (TBNA)
Chiba Foundation for Health Promotion & Disease Prevention 10.13039/100019567
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pmcIntroduction

Bronchoscopy plays an important role in the diagnosis and treatment of respiratory diseases. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a real-time ultrasound-guided bronchoscopic procedure that is performed using a convex probe EBUS scope. EBUS-TBNA has facilitated minimally invasive biopsy of mediastinal lymph nodes [1,2], with a higher diagnostic yield. Moreover, EBUS-TBNA has a sensitivity and specificity of 84 and 100% for detecting lung cancer, respectively [3]. Thus, it has been recommended as the best first test for mediastinal staging in patients with suspected lymph node metastasis [4].

Next-generation sequencing (NGS) has been used to assess advanced lung cancer [5,6]. NGS-based ancillary testing requires the acquisition of an adequate quantity and quality of tumor cells. The Oncomine Dx Target Test, a type of NGS based panel test, requires acquiring specimens containing 20–30% of viable tumor cells [7]. EBUS-TBNA has been useful for NGS testing [8,9], with a meta-analysis reporting an 86.5% success rate of specimens acquired using EBUS-TBNA [9]; however, we still need to pay enough attention to obtain adequate material for NGS-based testing by needle biopsy technique.

Currently, several types of needles are commercially available for EBUS-TBNA. Acquire™ Pulmonary (Boston Scientific, Natick, MA, USA), which uses a Franseen needle, was introduced in recent years. The Franseen needle moves forward, and the three tips at the top grasp specimens that are subsequently captured by the three cutting faces. This technique yields bigger tissue specimens with minimal fragmentation compared with those obtained using the Expect™ pulmonary, which uses a conventional Lancet needle (Fig. 1). The efficacy of the Franseen needle in endoscopic ultrasound-guided fine-needle aspiration of pancreatic tumors has been reported, with previous studies reporting that the tumor area and diagnosis rate of the Franseen needle were superior to those of conventional needles [10–12]. However, only a few studies have evaluated the usefulness of the Franseen needle in EBUS-TBNA [13–15], and evidence regarding the diagnostic rate and NGS testing remains to be established.

Figure 1 (A) The acquire™ pulmonary with a Franseen needle. (B) The expect™ pulmonary with a lancet needle. Images were provided by Boston Scientific and reprinted with permission.

Therefore, this study aimed to examine the advantages of the Franseen needle for EBUS-TBNA in terms of the quantity and quality of samples by histology (tissue area and tumor cellularity), success rate of NGS-based panel testing, and adverse events through a well-controlled prospective clinical comparison test.

Methods

Study design and patients

This single-center, prospective study was conducted at the Chiba University Hospital. This study was approved by the certified review board of Chiba University Hospital (identifier: CRB0063-22) and registered with the Japan Registry of Clinical Trials (identifier: jRCT1032220388).

Patients who met the following criteria were included in this study: (i) suspected primary lung cancer with lymph node metastasis; (ii) scheduled to undergo EBUS-TBNA; (iii) aged >20 years; and (iv) written informed consent provided voluntarily. Patients who met the following criteria were excluded: (i) a history of treatment for primary lung cancer and (ii) difficulty undergoing bronchoscopy. In addition, women who were pregnant, possibly pregnant, within 28 days postpartum, or lactating were also excluded.

Randomization

Patients who consented to participate in this study were randomly assigned to two groups: group A, wherein the first and second EBUS-TBNA were performed with the Expect™ Pulmonary with a 22 gauge (Boston Scientific, Natick, MA, USA) using a Lancet needle and the Acquire™ Pulmonary with a 22 gauge using a Franseen needle, respectively; and group B, wherein the first and second EBUS-TBNA were performed with the Acquire™ and the Expect™ Pulmonary, respectively. The groups were created to prevent bias due to the order.

The bronchoscopist was aware of the group allocation; however, the cytotechnologist and pathologist were blinded.

Bronchoscopy

All examinations were performed by the same certified bronchoscopist using a flexible bronchoscope (UC290F; Olympus, Tokyo, Japan). The bronchoscope was inserted orally under pharyngeal anesthesia. Pethidine, an analgesic, and midazolam, a sedative, were administered intravenously. Supplemental oxygen was provided to maintain the oxygen saturation of peripheral artery at >90%. The procedure time was defined as the duration between the insertion of the bronchoscope and its removal through the vocal cords.

Computed tomography (CT) images acquired up to 28 days before bronchoscopy were used to determine the lymph nodes to be punctured. The lymph nodes were identified using convex-probe endobronchial ultrasound and evaluated using elastography. EBUS-TBNA was performed subsequently according to the group allocation. The negative pressure of 20 ml was equally applied using VacLok syringe (MeritMedical, UT, USA). Rapid on-site evaluation was used during the procedure. Additional procedures, such as further EBUS-TBNA of the same or different lymph nodes and transbronchial biopsies, were performed if necessary.

Specimen preparation, cytopathological, and histopathological review

The specimens were categorized according to the procedure through which they were acquired: the first EBUS-TBNA, the second EBUS-TBNA, and additional procedures. The specimens were stored in buffered fixative CytoLyt solution (Hologic Inc., Tokyo, Japan) containing ~30% methanol. The cell blocks obtained via centrifugation were fixed in 10% neutral buffered formalin for 24–72 h. Subsequently, the cells were spread onto two glass slides: the first slide was fixed in 95% ethanol for Papanicolaou staining, whereas the second slide was air-dried and stained with Diff-Quik stain (American Scientific Products, McGaw Park, IL, USA) for rapid on-site evaluation, which was performed by a cytotechnologist.

A pathologist, who was blinded to the study, evaluated the pathological diagnoses and measured the tissue area (mm2), tumor cellularity (%), and blood contamination rates (%) for each specimen. The tissue area was calculated by capturing the tissue specimen on a virtual slide using image analysis software, Aperio ImageScope (Leica Biosystems, Nussloch, Germany). Tumor cellularity was defined as the ratio of the number of tumor cells and the total number of nucleated cells. The blood contamination rate was determined by calculating the area of blood on the tissue specimen and the ratio of the area of blood to the area of tissue. The values were estimated using a speculum or virtual slide in 10% increments, and 1 and 99% were used in cases wherein the values were significantly higher and lower.

NGS-based panel test (Oncomine Dx Target Test multi-CDx system; Thermo Fisher Scientific, San Jose, CA, USA) was performed for each study sample after the evaluation of tumor cell content by pathology (non-small cell lung cancer with a tumor content ratio of ≥20%).

Outcomes

The specimens obtained using the Franseen needle (the second EBUS-TBNA in group A and the first EBUS-TBNA in group B) were pathologically compared with the Lancet needle specimens (the first EBUS-TBNA in group A and the second EBUS-TBNA in group B).

The primary outcome measure was the tissue area of the specimens acquired using the Franseen and Lancet needles. It was hypothesized that the Franseen needle would acquire a greater amount of tissue samples based on the findings of previous studies. The secondary outcome measures included tumor cellularity of the specimens acquired using each needle, blood contamination rate, success rate of molecular testing, and incidence of adverse events. In addition, the results of tumor cell content evaluation prior to Oncomine Dx Target Test multi-CDx system and the success rate of NGS-based panel test were also recorded.

All adverse events observed during bronchoscopy and within 28 days of the procedure were recorded. The incidence of bleeding was recorded for each puncture. The degree of bleeding was defined as shown in Table 1, based on the findings of a previous study [16].

Table 1 Definition of bleeding

Grade	Findings	
None/trivial	No bleeding/bleeding but no suctioning of blood	
Minor	Suctioning of blood required for <1 min	
Moderate	Suctioning more >1 min required repeat wedging of the bronchoscope for persistent bleeding	
Severe	Tracheal intubation or balloon blocker for <20 min	
Very severe	Persistent tracheal intubation >20 min or new admission to the intensive care unit or need for bronchial artery embolization or resuscitation	
The definition was cited from reference 16 with modification by the authors.

Statistical analysis

We aimed to include 12 cases as the target sample size for the pilot study following the suggestion by clinical biostatistician [17]. Continuous data are presented as median and range, whereas categorical data are presented as numbers and percentages. For the primary outcome, the tissue area of the specimens, summary statistics were calculated and compared using a two-sample t-test. The secondary outcome for continuous variables was analyzed in the same way as for the primary outcome. For categorical data, summary statistics such as proportions was calculated and compared using the chi-square test. For adverse events, incidence rates were calculated. All statistical analyses were performed using SAS software (SAS Institute Inc., Cary, NC, USA).

Results

Study flow and patients

This study was conducted between November 2022 and February 2023. Table 2 summarizes the patient characteristics. Five (83.3%) male and one (16.7%) female patients were assigned to each of the two groups. The median age of the participants in groups A and B was 73.5 years (interquartile range [IQR]: 58.0–79.0 years) and 72.0 years (IQR 69.0– 74.0 years), respectively (P = .639). No significant differences were observed between the two groups in terms of background characteristics.

Table 2 Patient characteristics

	A group (N = 6)
Lancet → Franseen	B group (N = 6)
Franseen → Lancet	P value	
Sex			1.000	
Male, n	5	5		
Female, n	1	1		
Age, years	69.5 ± 15.0	72.7 ± 5.8	.639	
Body height, cm	165.3 ± 10.0	162.4 ± 8.2	.603	
Body weight, kg	63.9 ± 21.0	55.7 ± 9.4	.401	
Tobacco use			.296	
Yes, n	6	5		
No, n	0	1		

All 12 patients underwent bronchoscopy. Two samples in group B were found to be benign; therefore, an outcome analysis was performed using the remaining 10 cases (Fig. 2). Table 3 presents the bronchoscopy records of the remaining 10 patients. The punctured lymph nodes were commonly #7 and #4R. The mean size of the lymph node was 18.3 mm (IQR 14.4–21.2 mm) and 16.7 mm (IQR 14.0–36.0 mm) in groups A and B, respectively (P = .379). Elastography revealed blue findings in all lymph nodes. No significant differences were observed between the groups in terms of the duration of examination time and dose of anesthetic.

Figure 2 Flow diagram for study participants. Two samples in group B were excluded and outcome analysis was performed using the remaining 10 cases.

Table 3 Bronchoscopy records

	A group (N = 6)
Lancet → Franseen	B group (N = 4)
Franseen → Lancet	P value	
Lymph node station			.076	
#7, n	4	0		
#4R, n	1	3		
#11s, n	1	0		
#11l, n	0	1		
Lymph node size, mm	23.3 ± 10.2	32.2 ± 21.4	.379	
Elastgraphy			1.000	
Blue, n	6	6		
Needle pass, n	3.2 ± 1.3	4.0 ± 0.8	.300	
Examination time, min	17.4 ± 5.0	25.0 ± 19.4	.373	
Anesthesia				
Midazolam, mg	4.1 ± 1.8	4.0 ± 0.8	.934	
Pethidine, μg	26.3 ± 9.6	35.0 ± 0.0	.111	

Outcomes

Table 4 presents the results of the primary outcome and tissue area of each specimen. The mean tissue area of the specimens acquired using the Franseen and Lancet needles was 15.7 mm2 (IQR 6.5–17.1 mm2) and 12.3 mm2 (IQR: 6.2–14.9 mm2), respectively. The P-value was .355, indicating no significant differences. Figure 3 presents representative pathological images of a patient in this study. Table 5 presents the tumor cellularity and blood contamination rates of each specimen. The mean tumor cellularity of the specimens acquired using the Franseen and Lancet needles was 60.0% (IQR: 30.0–80.0%) and 40.0% (IQR: 20.0–80.0%), respectively (P = .608). The mean blood contamination rate of the specimens acquired using the Franseen and Lancet needles was 55.0% (IQR: 30.0–80.0%) and 45.0% (IQR: 20.0–90.0%), respectively (P = .971). The specimens acquired using the Franseen needle had higher values for both parameters; however, the differences were not statistically significant.

Figure 3 Histopathological images: Hematoxylin and eosin staining (×100). (A) Specimen obtained by the Franseen needle. (B) Specimen obtained by the lancet needle. (A) has a larger tissue area and higher tumor cellularity than image B.

Table 4 Tissue area of each specimen

	Franseen needle	Lancet needle	P value	
Tissue area, mm2	13.3 ± 6.4	10.6 ± 6.3	.355	

Table 5 Tumor cellularity and blood contamination rate of each specimen

	Franseen needle	Lancet needle	P value	
Tumor cellularity, %	54.0 ± 30.3	46.2 ± 36.3	.608	
Blood contamination rate, %	50.9 ± 33.0	50.3 ± 40.0	.971	

Among the 20 specimens acquired by single pass for targeted lymph node, 14 were diagnosed as non-small cell lung cancer. Among these 14 specimens, 10 demonstrated tumor cellularity of >20% (five samples by each needle). All specimens underwent Oncomine Dx Target Test multi-CDx system successfully, except for one specimen acquired using a Lancet needle. The success rates of molecular testing using single-pass sample were 85.7 and 57.1% for the Franseen and Lancet needles, respectively (Table 6).

Table 6 Success rate of molecular testing

	Franseen needle	Lancet needle	
Non small lung cancer	7	7	
Non small lung cancer with tumor cellularity >20%	6	5	
Successful molecular testing (%)	6 (85.7%)	4 (57.1%)	

Adverse events

Table 7 lists the adverse events observed in this study. Minor bleeding was observed in all 10 patients. Other complications included elevated blood pressure in two patients (20.0%), pneumonia in one patient (10.0%), and bronchoscope injury in one patient (10.0%). Table 8 summarizes the bleeding complications associated with the Franseen and Lancet needles. No serious bleeding-related complications were observed.

Table 7 Adverse events

Bleeding, n	10 (100%)	
Hypertension, n	2 (20%)	
Pneumonia, n	1 (10%)	
Bronchoscope injury, n	1 (10%)	

Table 8 Bleeding complications for each needle

Grade	Franseen needle	Lancet needle	
None/trivial	0	3 (30%)	
Minor	10 (100%)	7 (70%)	
Moderate	0	0	
Severe	0	0	
Very severe	0	0	

Discussion

The present study revealed two important findings. First, the Franseen needle tended to retrieve a larger amount of specimens with higher tumor cellularity than the Lancet needle; however, the difference was not statistically significant. Second, a single-pass sample by Franseen needle facilitated better success rate of NGS-based panel test.

This is the first prospective clinical study to examine the benefit of using the Franseen needle for EBUS-TBNA. The tissue area of the samples acquired using the Franseen needle was larger, and the tumor cellularity was higher in this study. This finding may be attributed to the shape of the three tips of the Franseen needle. Notably, the blood contamination rate tended to be higher for the Franseen needle; however, the difference was not statistically significant. Previous retrospective studies have reported that the amount of tissue specimen acquired using the Franseen needle is significantly larger [13,15]. In addition, Aboudara et al. [13] reported that the tumor cellularity of the specimens acquired using the Franseen needle was higher. EBUS-TBNA is performed via multiple needle passes; however, the specimens were obtained via one puncture in the present study. Therefore, further studies must be conducted to compare multiple-puncture specimens.

NGS-based panel test was performed successfully in most cases. Among the patients with tumor cellularity >20%, all specimens acquired using the Franseen needle underwent NGS testing successfully; however, one specimen acquired using the Lancet needle did not. Only the specimens acquired via a single puncture were included in this analysis. Uchimura et al. [18] reported that >4 core tissues obtained from EBUS-TBNA was a predictor of successful NGS testing. Multiple needles were used in their study, including Expect™ pulmonary. Acquire™ and Expect™ Pulmonary can retrieve sufficient core specimens via a single puncture. However, the use of Acquire™ with the Franseen needle is favored over the use of Expect™ with the Lancet needle. This may be attributed to the Franseen needles acquiring specimens with higher tumor cellularity. Bronchoscopy is a relatively invasive procedure; therefore, specimens should be obtained easily and within a shorter duration. Franseen needle may reduce the examination time in addition to reducing the number of punctures.

Currently, the diagnosis of advanced lung cancer requires NGS-based test, necessitating the acquisition of a large tumor volume [5,6]. The present study could not demonstrate the superiority of the Franseen needle; however, it was observed that the Franseen needle was superior in terms of tissue area, tumor percentage, and success rate of NGS testing. Thus, the Franseen needle has a certain level of usefulness overall. Further studies must be conducted to build evidence.

Serious complications were not observed in the present study. According to a survey conducted by the Japanese Society of Respiratory Endoscopy, bleeding and infection were reported in only 0.68 and 0.19%, respectively. Of the 7345 EBUS-TBNA procedures performed at 210 institutions between 2011 and 2012. The overall complication rate was 1.23% [2]. Only minor bleeding requiring suction for <1 min was observed in this study, and no serious adverse events were observed. Notably, the use of the Franseen needle resulted in a higher incidence of bleeding compared with the use of the Lancet needle; however, the difference was not significant, and the results were acceptable.

The present study has certain limitations. First, this was a single-center, phase II study conducted in Japan. Multi-center studies with randomization and a larger sample size must be conducted in the future to strengthen this evidence. Second, complications associated with the use of each needle, other than bleeding, were not compared. However, as no serious complications were observed in this study, the Franseen needle was expected to cause acceptable complications. Third, this study did not include punctures, such as #4L, which are difficult to approach. The Franseen needle may not be suitable for all patients undergoing EBUS-TBNA, and it may be necessary to use different needles for different lymph nodes. Finally, the difficulty of puncture of each needle was not verified in this study. Obviously, the difficulty of puncture differs between the Franseen and the Lancet needles. The difficulty of the technique should also play a role in the results, which should be quantified and evaluated in future studies.

Conclusions

This single-center prospective study evaluated the usefulness of the Franseen needle, which is expected to have an advantage in specimen collection and revealed that the Franseen needle tended to sample a larger amount of ‘core’ specimen with higher tumor cellularity than the conventional Lancet needle. Franseen needle seemed beneficial to NGS-based ancillary testing; hence, these results suggest that the use of the Franseen needle may be beneficial in practicing precision oncology. Further studies must be conducted to validate these findings.

Acknowledgements

We would like to thank Editage (www.editage.jp) for English language editing.

Author contributions

Kohei Shikano: conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, visualization, writing—original draft, writing—review and editing.

Jun Ikari: conceptualization, data curation, investigation, methodology, writing—review and editing.

Takahiro Nakajima: conceptualization, data curation, investigation, methodology, writing—review and editing.

Masayuki Ota: investigation, writing—review and editing.

Yuki Shiko: formal analysis, writing—review and editing.

Akira Naito: writing—review and editing.

Mitsuhiro Abe: writing—review and editing.

Takeshi Kawasaki: writing—review and editing.

Jun-Ichiro Ikeda: supervision, writing—review and editing.

Yoshihito Ozawa: supervision, writing—review and editing.

Takuji Suzuki: supervision, writing—review and editing.

Conflicts of Interest: TN received honoraria and lecture fee from Olympus and AstraZeneca for EBUS-TBNA training course.

Funding

Grants from Chiba Foundation for Health Promotion & Disease Prevention.

Ethical Statement

The study was performed in accordance with the amended Declaration of Helsinki. Written informed consent for bronchoscopy was obtained from each patient. Data anonymization and privacy issues were strictly addressed, and the study protocol was approved by the certified review board of Chiba University Hospital (identifier: CRB0063-22) and registered with the Japan Registry of Clinical Trials (identifier: jRCT1032220388).

Data availability

Derived data supporting the findings of this study are available from the corresponding author on request.
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