Assessing the Accuracy, Safety, and Tolerance of Office‐Based Endoscopic Biopsies for Laryngopharyngeal Lesions

ABSTRACT

Objective

The increasing prevalence of office‐based biopsies (OBBs) for diagnosing laryngopharyngeal lesions underscores the need for a comprehensive evaluation of their clinical utility. This study aims to investigate the accuracy, safety, and tolerance of these procedures in an office setting.

Methods

We conducted a retrospective analysis of 490 OBBs performed with distal chip, working channel endoscopes. Histologic accuracy was assessed by comparing OBB results with operating room biopsies or, for benign lesions, by monitoring endoscopic findings over time.

Results

The majority of OBBs were taken primarily from the glottic larynx (52.4%), supraglottic larynx (17.3%), and base of tongue (14.5%). Procedural intolerance led to noncompletion in 4.1% of cases due to gag reflex (17 cases) and laryngospasm (3 cases); no serious complications were reported. OBBs guided management in 88.4% of cases. Histologically, 33.3% of cases were benign, 27.6% pre‐malignant, 37.6% malignant, and 1.5% yielded inadequate specimens. Thirteen lesions (8.3%) initially identified as benign and 37 pre‐malignant lesions (28.5%) were found to be malignant upon further biopsy. For invasive malignancies/severe dysplasia, OBBs showed a sensitivity of 89.4%, specificity of 95.8%, positive predictive value of 97.4%, negative predictive value of 83.4%, and accuracy of 91.7%.

Conclusion

Office‐based biopsies of laryngopharyngeal lesions are safe, generally well‐tolerated, and offer reliable diagnostic results in appropriate clinical settings. Severe dysplasia or carcinoma in situ identified on OBB should prompt suspicion for invasive malignancy.

Level of Evidence

3

This prospective study assessed the accuracy, safety, and tolerance of 490 office‐based biopsies for the diagnosis of laryngopharyngeal lesions. Results showed that OBBs, mainly taken from the glottic and supraglottic larynx, were generally well‐tolerated, with a low complication rate and high diagnostic accuracy. The findings support that OBBs are a safe and effective tool for guiding management in laryngopharyngeal lesions, with high sensitivity and specificity for detecting malignancies.

1. Introduction

Malignancies arising in the laryngopharyngeal region are among the most prevalent head and neck cancers [1]. Delays in diagnosis can significantly increase tumor volume and progression, thereby exacerbating the patient's condition and complicating treatment options [2]. The overarching burden of laryngopharyngeal malignancies underscores the importance of accurate diagnostic procedures, such as biopsies, to facilitate timely and effective intervention.

Before the advent of working‐channel distal chip endoscopes, most biopsies of lesions in the larynx, hypopharynx, and base of the tongue were performed in the operating room under general anesthesia [3, 4]. Suspension laryngoscopy biopsies done in the operating room have notable advantages, including binocular magnification, bimanual dexterity for enhanced precision, and rigid instrumentation for obtaining deeper tissue samples. In contrast, office‐based biopsies (OBB) offer the benefit of obtaining tissue samples during the initial patient evaluation, leading to a shorter time to diagnosis and treatment [1, 5, 6, 7, 8, 9, 10], and reduced costs compared to operating room procedures [11, 12, 13, 14]. However, the small and often superficial samples obtained with the small working channel biopsy forceps used in OBB may result in under‐sampling, which can lead to diagnostic uncertainty. An early study by Cohen et al. demonstrated that OBBs have a sensitivity of only 69.2% for detecting malignant lesions of the larynx [3]. Due to the significant rate of false negatives, the study recommended that any OBBs yielding benign or pre‐malignant results should be followed up with a re‐biopsy performed in the operating room under general anesthesia to ensure a definitive diagnosis.

Despite these limitations, advancements in endoscopic technology, such as narrow‐band imaging and techniques to improve patient tolerance, have made office‐based procedures a valid alternative to traditional operating room biopsies. A recent systematic review by Owusu‐Ayim et al. found the overall accuracy of OBBs to be 81.6%, with a median sensitivity of 71.6% and a median specificity of 96.7% [15]. The review included a total of 1796 biopsies from 16 studies. These studies showed significant variances in diagnostic metrics, with reported sensitivities ranging from 60% to 100%, specificities from 75.6% to 100%, positive predictive values from 77% to 100%, and negative predictive values from 0% to 100% [1, 3, 5, 7, 8, 11, 14, 16, 17, 18, 19, 20, 21, 22, 23].

Given the uncertainty around the accuracy of OBBs, this study aims to further evaluate the efficacy, safety, and patient tolerance of OBBs for laryngopharyngeal lesions performed by a single surgeon at a single center. We hypothesize that OBBs are a safe, accurate, and well‐tolerated diagnostic approach, potentially reducing the need for operating room procedures while maintaining high diagnostic accuracy.

2. Materials and Methods

2.1. Study Design

This study was conducted with the approval of the Nova Scotia Health Research Ethics Board. A retrospective chart review was performed to identify patients who underwent OBBs of lesions in the larynx, base of the tongue, or hypopharynx between August 2013 and August 2023. All biopsies performed by the senior author during this period were screened to identify patients who underwent OBB.

2.2. Patient Selection

At our center, standard practice involves referring patients with lesions of the larynx, hypopharynx, base of the tongue, and oropharynx to our voice and airway clinic for OBBs. Patients who undergo general anesthesia for other procedures, such as tracheostomies, have their biopsies performed during the same operation rather than in the office. Additionally, submucosal lesions, obstructive lesions, or those difficult to access via transnasal endoscopy are typically biopsied using suspension laryngoscopy in the operating room (Figure 1).

FIGURE 1.

Flow‐chart of workup of laryngopharyngeal lesions. GA = general anesthesia.

All consecutive patients who underwent OBBs for benign or malignant lesions during the study period were included in the study. Both lesions suspected of malignancy and those with low suspicion were included, except for patients lost to follow‐up. Data collected included demographic information, lesion location, macroscopic characteristics, final T‐staging of carcinomas, number of biopsy specimens per procedure, pathology results (including those from subsequent operating room biopsies), patient tolerance, use of anticoagulant medications, and complications.

2.3. Biopsy Technique

All biopsies were conducted using flexible endoscopes (ENF‐VT2, Olympus Corporation, Tokyo, Japan) with 2‐mm working channels. Samples were obtained using 1.9‐mm fenestrated, oval‐cup biopsy forceps (FB‐321D). Patients' nasal passages were first anesthetized with aerosolized 4% lidocaine, and the endoscope was lubricated with lidocaine jelly. For laryngeal biopsies, transtracheal instillation of lidocaine was used alongside laryngeal gargle techniques.

To administer transtracheal lidocaine, a 3 mL syringe filled with 2 mL of 4% lidocaine was prepared. The cricothyroid space was palpated, and a 25‐gauge needle was inserted through the cricothyroid membrane. After confirming the needle's placement by withdrawing air into the syringe, 2 mL of lidocaine was quickly injected into the airway. The needle was carefully withdrawn to avoid injecting lidocaine into the tracheal wall.

Aerosolized 4% lidocaine was sprayed on the back of the patient's oropharynx, and additional 4% lidocaine was dripped over the glottis using either an Abraham cannula or the endoscope's working channel, while the patient vocalized to perform a laryngeal gargle. For supraglottic and oropharyngeal lesions, 4% lidocaine was also applied using either an Abraham cannula or the endoscope's working channel.

For patients with low tolerance, Ativan was occasionally administered pre‐procedure, along with inhalation of nebulized lidocaine. Narrow band imaging was used during all biopsies to enhance visualization of mucosal changes and abnormal vascular patterns, guiding optimal biopsy site selection. For glottic lesions, stroboscopy was utilized to help estimate the depth of invasion. Approximately three representative samples were taken from each lesion.

2.4. Patient Management and Follow‐Up

Patients whose OBBs showed benign lesions, including mild and moderate dysplasia consistent with the clinical context, were followed for at least 6 months and advised to return if any voice or throat symptoms developed. Patients with risk factors, such as smoking, persistent hoarseness, or visible lesions, were followed for extended periods with a lower threshold for re‐biopsy. If concerning changes were detected or there was a lack of resolution of the lesion, these patients underwent repeat OBBs or biopsies in the operating room. Patients with pre‐malignant or malignant lesions were monitored and managed according to standard protocols (Figure 1).

2.5. Data Collection and Analysis

The primary outcomes of interest were the rates of true positives, true negatives, false positives, and false negatives. For statistical analysis, the histology of the OBBs was categorized into two groups: benign and (pre‐)malignant. The benign group included reactive lesions, inflammation, papilloma, keratosis, acanthosis, mild dysplasia, and moderate dysplasia. The (pre‐)malignant group comprised severe dysplasia, carcinoma in situ (CIS), and invasive malignancy. These categories were selected based on their clinical management: lesions in the benign group can generally be monitored, while those that are severely dysplastic, CIS, or invasive malignancy typically require intervention [24, 25]. A similar categorization has been used in previous studies [3, 7, 20, 26, 27]. Biopsies showing lymphoma (n = 3) were removed from the diagnostic assessment evaluation and statistical analysis.

Lesions that remained benign throughout the follow‐up period were classified as true negatives. These benign lesions were monitored for at least 6 months with endoscopic evaluations or repeat biopsies conducted as needed. Lesions with histology showing severe dysplasia, CIS, or invasive carcinoma were classified as true positives and were treated accordingly. Lesions initially classified as benign in the OBB that were later found to be severe dysplasia/CIS/invasive carcinoma during operating room biopsies were considered false negatives. If subsequent biopsies still did not align with the clinical context, such as fine‐needle aspiration (FNA) cytology of neck masses or PET‐CT scan findings, the OBB results were also considered false negatives. Office‐based biopsy results were considered false positives if subsequent biopsies performed in the operating room downgraded the histology from the (pre‐) malignant group to the benign group.

2.6. Statistical Methods

Diagnostic accuracy measures were calculated using MedCalc version 22 (MedCalc Software, Ostend, Belgium). Chi‐square tests were used to compare false negative rates across different laryngopharyngeal locations, to assess whether a history of previous cancer at the biopsied site affected false negative rates, and to evaluate false negative rates for biopsies of submucosal lesions. After removing pathologically benign tumors, logistic regression was used to assess which factors were predictors for false negatives. For T stage, which had multiple categories, multiple comparisons were accounted for using Tukey's Honest Significant Differences. Missing data were addressed by excluding incomplete cases from the analysis. A significance level of 0.05 was set for all analyses.

3. Results

During the study period, 490 consecutive procedures were performed on 431 patients. Office‐based biopsies were conducted at the following subsites: glottic larynx (257 cases, 52.4%), supraglottic larynx (85 cases, 17.3%), base of tongue (71 cases, 14.5%), hypopharynx (35 cases, 7.1%), nasopharynx (16 cases, 3.3%), oropharynx (11 cases including 3 tonsil biopsies, 2.2%), subglottic larynx (13 cases, 2.7%), and neopharynx (2 cases, 0.4%). Most patients were male (78%), with an average age of 67.8 years (SD 10.6, range 33–94). Of the patients undergoing OBBs, 115 had previously treated squamous cell carcinoma (SCC) in the area being biopsied.

Twenty of the 490 procedures (4.1%) were not completed due to poor patient tolerance, primarily due to a strong gag reflex in 17 cases and laryngospasm in 3 cases. Of the 470 completed procedures, 159 (33.8%) patients were on blood thinners. There were no significant bleeding issues or complications during any of the procedures. Based on pathology reports of the initial OBBs, 156/470 (33.4%) were benign lesions, 130/470 (27.7%) were pre‐malignant lesions (mild, moderate, and severe dysplasia/CIS), and 177/470 (37.7%) were invasive malignancies (Figure 2). Invasive malignancies included SCC (170/177, 96.0%), lymphoma (3/177, 1.7%), adenocarcinoma (1/177, 0.6%), neuroendocrine carcinoma (1/177, 0.6%) and nasopharyngeal carcinoma (2/177, 1.1%) (Table 1). The successful sampling rate was 98.5%, with only 7 specimens being inadequate for interpretation.

FIGURE 2.

Flow chart of office‐based biopsy results and management.

TABLE 1.

Accuracy of OBBs for different pathologies.

OBB pathology	N	Accuracy compared to final pathology	Pathology of missed diagnosis (false negatives)	Rates of false negatives
SCC	170	100%	N/A	0%
Lymphoma	3	100%	N/A	0%
Neuro endocrine carcinoma	1	100%	N/A	0%
Adenocarcinoma	1	100%	N/A	0%
Nasopharyngeal carcinoma	2	100%	N/A	0%
Severe dysplasia	47	55.0%	SCC	30.0%
			CIS	15.0%
Carcinoma in situ	44	65.9%	SCC	34.1%
Moderate dysplasia	15	66.6%	Severe dysplasia	6.7%
			CIS	6.7%
			SCC	13.3%
			Nasopharyngeal Ca	6.7%
Mild dysplasia	22	77.3	Severe dysplasia	4.5%
			SCC	18.2%
Reactive lesions (hyperplasia, polyp)	31	100%	N/A	0%
Inflammation (granulation)	53	90.6%	CIS	1.9%
			SCC	5.7%
			Lymphoma	1.9%
Papilloma	25	100%	N/A	0%
Keratosis	21	76.2%	Severe dysplasia	4.8%
			SCC	14.3%
			Adenoid cystic carcinoma	4.8%
Metaplasia	2	50%	Clear cell tumor	50%
Necrosis	2	0%	SCC	100%
Reactive Atypia	5	60%	SCC	40%

The mean number of biopsies per procedure was 2.8 (SD 1.3, range 1–9). The number of biopsy pieces did not have a significant impact on false negative rates (p = 0.445, OR = 0.87 [0.59–1.23 95% CI], Table 2).

TABLE 2.

Logistic regression results for predicting false negatives.

Predictor	Coefficient	Std. error	z	p	OR (95% CI)
Constant (Intercept)	1.123	1.598	0.703	0.48224
Submucosal lesion	2.248	0.821	2.738	0.00617	9.5 (1.71–48.19)
Age	−0.0356	0.0209	−1.702	0.08872	1.0 (0.93–1.01)
Sex	−0.677	0.479	−1.412	0.15781	0.5 (0.21–1.38)
Previous cancer	0.0411	0.471	0.087	0.93051	1.0 (0.39–2.53)
Number of biopsies/pieces	−0.141	0.184	−0.764	0.44497	0.9 (0.59–1.23)

Of the 12 submucosal lesions biopsied, 4 were false negatives, which was statistically significant (Pearson χ² = 10.201, p = 0.0014). Patients with submucosal involvement were 9.5 times more likely to have a false negative result (p = 0.00617, OR = 9.47 [1.71–48.19 95% CI], Table 2).

As shown in Table 3, biopsies performed at the base of the tongue had the highest false negative rates at 10.3%. However, there was no correlation between the biopsy location and false negative rates (Pearson χ² = 6.96, p = 0.433).

TABLE 3.

False negative rate by biopsy location.

Biopsy Location	N	False negatives	False negative rate (%)
Glottic larynx	257	18	7.0%
Supraglottic larynx	85	4	4.7%
Base of tongue	71	7	9.9%
Hypopharynx	35	3	8.6%
Nasopharynx	16	0	0%
Oropharynx	11	0	0%
Subglottis	13	0	0%
Neopharynx	2	0	0%

False negative rates were assessed based on the final tumor staging of the lesions. Figure 3 shows the distribution of tumor stages for the biopsied lesions, while Figure 3b illustrates the false negative rates associated with each stage. Lesions with a final diagnosis of severe dysplasia or CIS had a false negative rate of 14.7%. T1 lesions had a false negative rate of 5.9%, which increased to 20.4% for T4 lesions. No significant differences were found among the tumor stages in terms of false negative rates.

FIGURE 3.

(a) Final staging of biopsied lesions; (b) false negative rates by final T stage. CIS = carcinoma in situ. [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]

OBBs effectively guided management in 88.4% of cases. Discrepancies between clinical context and histologic findings occurred in 8.0% of cases, necessitating repeat biopsy in the operating room. Repeat biopsies performed under general anesthesia upstaged 13 out of 156 (8.2%) initially benign cases to invasive malignancy (Table 4). Office‐based biopsies showing mild to moderate dysplasia were later found to be invasive malignancies in 18.2% to 20% of cases, while severe dysplasia or CIS were identified as invasive malignancies in 31.9% of cases upon re‐biopsy in the operating room (Table 4). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for invasive malignancy in OBBs were 74.9%, 100%, 100%, 78.9%, and 87.0%, respectively. For severe dysplasia/CIS/invasive malignancy, these values were 89.2%, 95.8%, 97.4%, 83.4%, and 91.6%, respectively (Table 5). When evaluating the concordance between OBBs and the final pathological diagnosis after surgical excision, a total of 187 lesions underwent subsequent biopsies in the operating room. The final diagnoses of lesions initially found to be non‐malignant based on histopathology are presented in Table 4. While most lesions biopsied were squamous cell carcinoma, Table 1 shows the various pathologies encountered in the study and the corresponding diagnostic accuracy of OBBs for that pathology.

TABLE 4.

Final diagnosis of patients with no malignancy on initial office‐based biopsy.

Initial OBB pathology	Total #	Malignant #	%	Pre‐malignant #	%	No evidence of malignant or pre‐malignant #	%
Benign	156	13	8.2	4	2.5	120	76.4
Reactive lesion	31	0	0.0	0	0.0	31	100.0
Inflammation	53	6	11.3	1	1.9	46	86.8
Papilloma	25	0	0.0	0	0.0	25	100.0
Keratosis	21	4	19.0	1	4.8	16	76.2
Necrosis	2	2	100.0	0	0.0	0	0.0
Metaplasia	2	1	50.0	1	50.0	0	0.0
Atypia	5	2	40.0	1	20.0	2	40.0
Pre‐malignant	130	37	28.5	91	70.0	3	2.3
Mild dysplasia	22	4	18.2	16	72.7	2	9.1
Moderate dysplasia	15	3	20.0	12	80.0	0	0.0
Severe dysplasia/CIS	94	30	31.9	63	67.0	1	1.1

Abbreviations: CIS = carcinoma in situ; OBB = office‐based biopsy.

TABLE 5.

Diagnostic table of office‐based biopsies for malignancy and malignancy/high‐grade dysplasia.

	Diagnostic test of OBB for
	Malignancy		Malignancy/CIS/severe dysplasia
Diagnostic values	Value, %	(95% CI)	Value, %	(95% CI)
Sensitivity	74.90	(68.90–80.26)	89.15	(85.03–92.46)
Specificity	100.00	(98.37–100.00)	95.83	(91.60–98.31)
LR (+)	(−)		21.40	(10.35–44.24)
LR (−)	0.25	(0.20–0.31)	0.11	(0.08–0.16)
PPV	100.00	(97.96–100.00)	97.41	(94.78–98.73)
NPV	78.95	(75.08–82.36)	83.42	(78.36–87.48)
Accuracy	87.07	(83.67–89.99)	91.58	(88.66–93.94)

Abbreviations: CI = confidence interval; LR (+) = positive likelihood ratio; LR(−) = negative likelihood ratio; NPV = negative predictive value; OBB = office‐based biopsy; PPV = positive predictive value.

4. Discussion

Our findings support the utility of office‐based biopsies (OBBs) for laryngopharyngeal lesions, showing high accuracy, safety, and tolerance in the appropriate setting. With a sensitivity of 89.2% and specificity of 95.8% for detecting severe dysplasia, CIS, or invasive malignancy, our study's diagnostic accuracy (91.6%) aligns closely with prior research by Cha et al., which reported 91.3% accuracy for detecting severe dysplasia, CIS, or invasive malignancy in 571 cases [20].

Our findings indicate that false negatives were more common for submucosal lesions as well as larger, more necrotic lesions, where deeper samples may have been required for accurate diagnoses. Notably, even some larger T4 lesions yielded inaccurate results when biopsied in the operating room. This underscores the importance of combining OBB results with other diagnostic modalities, such as clinical examination, imaging, and fine‐needle aspirations of neck nodes when present, to arrive at an accurate diagnosis. While there was no statistical significance in the rates of false negatives between the various biopsy locations, the base of the tongue had the highest rate of false negatives at 10.3% (Table 3). Similarly, Mohammed et al. found high rates of non‐diagnostic tongue base biopsies despite repeated attempts to obtain deeper samples in the same location [23]. Similar to a study by Chang et al., we did not find any difference in the accuracy of biopsies performed and patients with and without a history of SCC in the location being biopsied [19]. We propose that for lesions that appear overtly pathological, submucosal in nature, or are located at the base of the tongue, a benign result from an initial OBB should warrant re‐biopsy under suspension laryngoscopy.

Non‐malignant diagnoses from OBBs should be interpreted cautiously. As shown in Table 4, 8.2% of benign lesions and 28.5% of pre‐malignant lesions identified on OBB were found to be invasive malignancies upon repeat biopsy in the operating room. Among the pre‐malignant lesions later confirmed as malignant, 18.2% were initially identified as mild dysplasia, 20.0% as moderate dysplasia, and 31.9% as severe dysplasia/CIS. Rather than providing a definitive grade of dysplasia or confirming invasion, the primary utility of OBBs likely lies in assessing the need for further intervention versus observation. Due to the small and superficial nature of OBB samples, pathologists often cannot assess invasion accurately because of inconsistent sampling of the basement membrane. However, since severe dysplasia and CIS are typically managed similarly to early T1 cancer—with treatment options including radiation therapy or endoscopic resection—the limitations of OBBs in distinguishing severe dysplasia, CIS, and invasive carcinoma may be inconsequential. The high sensitivity (89.2%) and specificity (95.8%) for diagnosing severe dysplasia/CIS/invasive malignancy, as demonstrated in our study, underscore the value of OBBs in guiding patient management decisions.

Reported diagnostic metrics for OBBs vary widely, with sensitivities from 60% to 100% and specificities from 75.6% to 100% [15]. These differences may be variances in technology used or study methodology. Advanced imaging technologies such as Narrow Band Imaging (Olympus), i‐Scan (Pentax), and SPIES (Storz) enhance visualization of mucosal structures and vascular patterns, facilitating better localization of lesions compared to white light endoscopy [19, 28, 29, 30, 31, 32, 33]. Bäck et al. found that the sensitivity of OBBs increased from 62% to 100% when using Narrow Band Imaging compared to white light endoscopy [32]. Without the use of these newer imaging modalities, a lower threshold for re‐biopsy after OBB may be warranted.

Methodological factors may contribute to variations reported among studies. Debate exists regarding classification systems for dysplasia, with low interobserver reliability in distinguishing dysplasia grades [34, 35, 36, 37, 38]. In our study, severe dysplasia and CIS were grouped together due to similar treatment approaches and malignant transformation risks [24, 25]. While other studies also combined these categories for statistical analysis [3, 7, 20, 26, 27, 39], not all specify their threshold for what constitutes a true positive, making comparisons challenging. Additionally, while some studies re‐biopsied all lesions initially deemed benign in the operating room [3], others, including ours, re‐biopsied benign lesions only when clinically indicated [20].

There were no significant complications in our study. A systematic review by Lim et al. found that complications from OBBs are typically minor and self‐limited [6]. However, Wellenstein et al. reported a rare case of laryngeal edema following an in‐office biopsy that required tracheostomy, underscoring the need to perform these procedures in hospital settings equipped for airway management [40]. Among 159 patients (33.8%) on anticoagulants, no significant bleeding occurred, consistent with other studies showing no increased risk with anticoagulant use during in‐office laryngology procedures [41, 42]. Nonetheless, there has been a case of intractable bleeding during an awake injection laryngoplasty, which required intubation and additional intervention to control the hemorrhage [43]. Although these events are rare, they emphasize the necessity of anticipating serious complications related to airway and bleeding management. Patient intolerance prevented biopsy completion in 4.1% of cases (20/490), a rate comparable to those reported by Cohen et al. (5.9%) [5] and Lippert et al. (1.7%) [1]. In our study, patients unable to tolerate the procedure were rescheduled with anxiolytic medication and nebulized lidocaine or were biopsied in the operating room.

5. Limitations

The main limitation of this study is that it is not a true cross‐sectional diagnostic accuracy study, as not all OBBs were confirmed with repeat biopsies in the operating room. Instead, cases identified as benign on OBBs were presumed accurate unless the clinical course indicated otherwise.

Minimum follow‐up standards for benign and mild to moderate dysplasia are debated. Several studies recommend at least 6 months of follow‐up [20, 25], but a systematic review by Weller et al. found no evidence to support early discharge, as the timeline for malignant transformation can vary significantly [24]. In this study, patients were generally followed for 6 months unless symptoms developed, which may have led to some being lost to follow‐up. Longer follow‐up periods also complicate determining whether initial biopsies were accurate or if malignant transformation occurred.

Combining base of tongue and oropharyngeal lesions with laryngeal lesions for sensitivity and specificity calculations may be a confounding factor. Many oropharyngeal squamous cell carcinomas are HPV‐associated, making dysplasia or CIS diagnoses less common in these regions. If a lesion from these areas stains positive for p16, it is classified as HPV‐associated squamous cell carcinoma, even if it resembles dysplasia. By broadly defining a true positive to include severe dysplasia, CIS, and invasive malignancy, we aimed to assess the overall accuracy of OBBs for laryngopharyngeal lesions.

Finally, the success of OBBs may depend on the pathologist's expertise. While this study was conducted with a head and neck pathologist experienced in interpreting small endoscopic biopsies, this may not be representative of all centers. Pathologists must be able to recognize and report when invasive malignancy cannot be ruled out to help guide surgeons in appropriately managing patients.

6. Conclusion

This study, the second largest to date, evaluates the accuracy, safety, and tolerance of OBBs for laryngopharyngeal lesions over a 10‐year period. Our findings demonstrate that OBBs are generally safe, well‐tolerated, and provide reliable diagnostic results in appropriate clinical settings. In health care systems with limited resources, OBBs can be a valuable tool for the initial workup of patients presenting with concerning lesions. They expedite diagnosis and management, are cost‐effective, and offer a practical alternative to operating room procedures for many patients.

Conflicts of Interest

The authors declare no conflicts of interest.

Clark A., Nam Y. S., MacKay C., Bullock M., and Brown T., “Assessing the Accuracy, Safety, and Tolerance of Office‐Based Endoscopic Biopsies for Laryngopharyngeal Lesions,” The Laryngoscope 135, no. 9 (2025): 3287–3295, 10.1002/lary.32197.