Articles published on Polyp size
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- New
- Research Article
- 10.1111/jgh.70198
- Dec 3, 2025
- Journal of gastroenterology and hepatology
- Lin Lin + 13 more
This study aims to evaluate the diagnostic performance of an enhanced artificial intelligence-assisted colonoscopy system, CAD-N-Pro, based on the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification. Compared to the previous CAD-N system, this study optimized the algorithm into a segmentation network to comprehensively assess the diagnostic performance of the CAD-N-Pro model. A total of 14 675 images from 5 hospitals were classified using the NICE classification for training, internal and external validation. The model's performance was also compared with the previous CAD-N model. To validate the clinical applicability, 200 colonoscopy videos were prospectively collected and analyzed, with comparisons made among endoscopists of different seniority. In external image validation, CAD-N-Pro demonstrated excellent diagnostic accuracy across polyp types, with an overall AUC of 0.979. The system achieved accuracies of 0.966 for type 1 polyps and type 2 polyps (95% CI 0.956-0.975), and 0.997 for type 3 polyps (95% CI 0.993-0.999), 0.994 for normal background (95% CI 0.990-0.997). In the video validation, the performance of CAD-N-Pro was demonstrated to be superior to that of endoscopists with different years of experience, particularly in the diagnosis of type 1 and type 2 polyps. Moreover, CAD-N-Pro exhibited superior performance to endoscopists in detecting colorectal polyps of different sizes, especially those < 10 mm. For polyps larger than 10 mm, its performance was comparable to that of endoscopists with > 3 years of experience. The optimized CAD-N-Pro model enhances optical diagnostic accuracy for colorectal polyps, providing a robust tool for clinical decision-making in real-time colonoscopy examinations.
- New
- Research Article
- 10.61940/jimt.250011
- Nov 30, 2025
- Journal of Innovative Medical Technology
- Gwang Ha Kim
Advancements in endoscopic techniques for accurate colorectal polyp size measurement
- New
- Research Article
- 10.35314/4qmfa987
- Nov 29, 2025
- INOVTEK Polbeng - Seri Informatika
- William Tanuwijaya + 1 more
This study proposed a modification to the Attention U-Net architecture by integrating a Residual-Gated mechanism and Squeeze-and-Excitation (SE) Block-based channel recalibration within the Attention Gate to enhance feature selectivity in polyp segmentation. This integration reinforces both spatial and channel attention, enabling the model to better highlight polyp regions while suppressing irrelevant background features. Experiments were conducted on three colonoscopy datasets, CVC-ClinicDB, CVC-ColonDB, and CVC-300, using IoU and DSC metrics. Compared to the Attention U-Net baseline, the proposed model achieves noticeable improvements, with performance gains of mIoU 0.0043 and mDSC 0.0094 on CVC-ClinicDB, mIoU 0.0012 on CVC-ColonDB, and a larger margin of mIoU 0.0224 and mDSC 0.0127 on CVC-300. The best results were obtained on CVC-ClinicDB (mIoU 0.8889, mDSC 0.9412). Although the absolute scores on CVC-ClinicDB and CVC-ColonDB are lower than those reported in several recent studies, these datasets contain higher variability in polyp size, boundary ambiguity, and illumination, contributing to more challenging segmentation conditions. Visual evaluation further shows smoother and more coherent boundaries, especially on small or low-contrast polyps. Overall, the integration of the residual-gated mechanism and SE block within the attention gate effectively improves model accuracy and generalization, particularly in challenging scenarios.
- Research Article
- 10.1097/mcg.0000000000002119
- Nov 1, 2025
- Journal of clinical gastroenterology
- Eric Smith + 10 more
Thermal ablative methods (such as argon plasma coagulation (APC) and soft tip snare coagulation (STSC) are commonly used to treat polyp margins. We aim to appraise the current literature and compare clinical outcomes between patients with treated (with APC vs. STSC) and non-treated endoscopic mucosal resection (EMR) margins. We searched major databases from inception until November 2023 for randomly controlled trials (RCTs) comparing EMR of large non-pedunculated colorectal polyps with and without treated margins. Pooled data were analyzed for the primary outcome of recurrence at first screening colonoscopy, and adverse events. Analysis was performed using a random effects model and data were reported using 95% CIs. A total of 5 RCT's were found, which included 1020 polyps (577 in treatment and 443 in control groups). Three studies included treatment with STSC and 3 studies used APC as the modality for margin ablation. Of the included patients, 53% were female and the average age was similar between treatment and control groups (65.9 vs. 66.1y). Seventy-one percent of lesions were proximal to the splenic flexure. The mean follow-up to the first colonoscopy and average polyp size were comparable (6.3 vs. 6.2mo; 28.2 vs. 28.0mm, respectively). Pooled analysis showed that margin ablation was associated with significantly lower rates of recurrence [odds ratio (OR) 0.267, 95% CI 0.18-0.4, P<0.001] with low heterogeneity between studies (I2=0%, P=0.47). Pooled analysis showed no significant difference between STSC and APC in terms of recurrence (OR 0.6, 95% CI 0.27-1.7, I2=0%, P=0.3) or adverse events (OR 0.67, 95% CI 0.3-1.6, I2 13%, P=0.46). Our study shows that ablation of EMR margins is very effective at preventing recurrence at first surveillance colonoscopy. We found no difference between STSC or APC in terms of polyp recurrence or adverse outcomes.
- Research Article
- 10.1016/j.ejrad.2025.112400
- Nov 1, 2025
- European journal of radiology
- Marc J Gollub + 10 more
Value of rectal MRI prior to endoscopic submucosal dissection (ESD): an exploratory study.
- Research Article
- 10.17235/reed.2025.11539/2025
- Oct 23, 2025
- Revista espanola de enfermedades digestivas
- Yong Li + 9 more
Precise polyp size measurement is vital for treatment and follow-up strategy determination, with small polyps (<10 mm) presenting particular challenges. This study aimed to develop an artificial intelligence system, PolypM, for automated polyp size measurement to enhance clinical decision-making. PolypM, comprising two models, was designed for automatic segmentation of transparent caps and polyps. It was trained on 6486 endoscopic images (Dataset 1), validated on 675 images (Dataset 2), and compared to endoscopists' measurements on 542 images (Dataset 3). The PolypM trained on Dataset 1 achieved an intersection over union (IoU) of 0.91 [95% confidence interval (CI): 0.89-0.93] for segmenting transparent caps, an IoU of 0.75 (95% CI: 0.71-0.79) for segmenting polyps, and an intraclass correlation coefficient (ICC) of 0.682 compared to the gold standard in Dataset 2. The PolypM also demonstrated comparable accuracy on Dataset 3. In the multicenter external validation, the PolypM outperformed endoscopists in both average absolute error and average relative error in determining polyp size (P<0.05) regardless of polyp morphology, pathological characteristics, or endoscopists' experience. PolypM, an interpretable system for colonic polyp size estimation, was developed to mitigate measurement ambiguity and facilitate decision-making regarding surgical intervention and postoperative surveillance timing.
- Research Article
- 10.1055/a-2689-5839
- Oct 16, 2025
- Endoscopy International Open
- Tonya Kaltenbach + 7 more
Background and study aimsAlthough endoscopic resection is recommended for management of complex benign colon polyps, patients are routinely referred for surgical resection. Little is known about the effects of these elective colectomies on patient outcomes. We sought to determine trends, surgical outcomes, and costs of elective colectomy for benign colon polyps.Patients and methodsWe performed a retrospective cohort analysis of veterans nationwide using the National Veterans Affairs Surgical Quality Improvement Program (VASQIP) database linked to the national VA Corporate Data Warehouse database. We included all veterans (N = 7,102) undergoing elective colectomy for benign polyps from 2000 to 2015. Outcomes of interest were rates of colectomy, surgical pathology findings, morbidity, mortality, and costs.ResultsColectomy for benign polyps increased significantly from 6% of all colectomies in 2000 to 18% in 2014, and the percent of colectomies for colon cancer decreased from 40% to 31%. The 30-day mortality rate was 1.2% and the complication rate was 19.7%. Based on pathology, 80% of patients (n = 514) underwent right hemicolectomy, mean polyp size was 2.7 cm (± 1.7 cm), and 60.1% of resected polyps were adenomas. Median cost of colectomy was $22,712 for open and $20,697 for laparoscopic colectomy. Costs increased if a complication occurred.ConclusionsRates of colectomy for benign adenomas significantly increased from 2000 to 2014. Colectomy was associated with significant mortality, morbidity, and cost. Development of strategies to improve endoscopic management of benign large colon neoplasms is urgently needed.
- Research Article
- 10.1016/j.crad.2025.107024
- Oct 1, 2025
- Clinical radiology
- L Jiang + 8 more
Multilevel scoring systems based on ultrasound for differentiating between gallbladder adenomatous polyps and non-neoplastic polyps.
- Research Article
- 10.1097/md.0000000000043899
- Sep 26, 2025
- Medicine
- Chunzhi Sheng + 2 more
Patients with endometrial polyps often exhibit irregular menstrual symptoms, and even after hysteroscopic removal of endometrial polyps, some patients' menstrual disorders do not show significant improvement. This study retrospectively included 450 patients, with 355 patients showing significant improvement in menstrual disorders and 95 patients showing no significant improvement. Analyze the demographic, clinical characteristics, and surgical related factors of patients in these 2 situations, as well as the differences in hormone levels before and after treatment. Further, support vector machine can be used to screen the influencing factors of poor efficacy and construct a risk model. Perform multivariate regression analysis to examine the impact of the risk model and its interaction on poor efficacy. Construct a nomogram to further analyze the risk of poor therapeutic efficacy. The top 5 important features selected by support vector machine include progesterone changes, luteinizing hormone changes, polyp morphology, polyp type, and polyp location. The AUC (area under curve) of the constructed risk model is 0.701, indicating high predictive ability. In addition to the risk model, age, BMI (body mess index), menstrual duration, endometrial thickness, polyp size, and follicle stimulating hormone changes are also significant independent factors for poor therapeutic efficacy. The interaction indicates that the risk model performs better in patients with longer menstrual periods or larger polyps. Nomogram have high accuracy and clinical application value. The risk model we constructed has a good ability to predict poor therapeutic efficacy, and the nomogram provides a reference for clinical doctors' decision-making.
- Research Article
- 10.1016/j.anl.2025.08.012
- Sep 25, 2025
- Auris, nasus, larynx
- Toshiyuki Mitsuhashi + 10 more
Phonosurgery for vocal fold polyps: A comprehensive analysis of multidimensional voice outcomes in 201 cases and the impact of polyp size.
- Research Article
- 10.1055/a-2663-7661
- Sep 22, 2025
- Endoscopy
- Megan Oleksiw + 13 more
Computer-aided diagnosis (CADx) of colorectal polyps during colonoscopy could replace pathology for certain polyps. This study aimed to evaluate CADx-assisted optical diagnosis for polyps of ≤10 mm in the context of established quality benchmarks.We performed a post-hoc analysis of a randomized controlled trial evaluating assistive versus autonomous computer-aided optical diagnosis. Our primary outcome was achievement of the American Society for Gastrointestinal Endoscopy PIVI1 threshold for resect-and-discard implementation when CADx was used for polyps ≤3 mm. Secondary outcomes included PIVI1 threshold achievement when using CADx with a size cutoff of ≤5 mm and ≤10 mm, as well as diagnostic performance and prevalence of advanced histology across the polyp size groups.We included 313 patients with a total of 463 polyps of ≤10 mm undergoing optical diagnosis with CADx assistance. Compared with pathology-based intervals, surveillance interval agreement was 94.6% (95%CI 91.3%-96.7%), 89.5% (95%CI 85.4%-92.5%), and 85.9% (95%CI 81.5%-89.5%) when CADx was used with size cutoffs ≤3 mm, ≤5 mm, and ≤10 mm, respectively. The diagnostic accuracy of CADx-assisted optical diagnosis was 76.2%, 76.6%, and 72.5% for polyps sized ≤3 mm, >3 to ≤5 mm, and >5 to ≤10 mm, respectively. The negative predictive value for rectosigmoid adenomas was >90% for all size groups (PIVI2). The prevalence of advanced or serrated pathology was higher in polyps >3 mm, which resulted in a higher number of incorrectly assigned surveillances intervals.In our study, CADx-assisted optical diagnosis met the resect-and-discard PIVI1 threshold only with a size cutoff of ≤3 mm, and the diagnose-and-leave PIVI2 threshold for polyps ≤10 mm.
- Research Article
- 10.2147/jmdh.s524337
- Sep 6, 2025
- Journal of Multidisciplinary Healthcare
- Shan Yuan + 4 more
ObjectiveThis study aimed to reduce the incidence of hypoglycemia following endoscopic polypectomy by implementing Quality Control Circle (QCC) interventions.MethodsQuality Control Circle (QCC) empowered clinicians to implement PDCA-driven protocol refinements, standardizing care processes to mitigate hypoglycemia risk. Establish a QCC team to investigate the current incidence of hypoglycemia in post-polypectomy patients, conduct a root cause analysis to identify the true causes, formulate corresponding countermeasures, and implement them in phases. The study was conducted in two phases: before-QCC (517 patients from March 13 to May 31, 2023) and after-QCC (1090 patients from June 1 to November 30, 2023). The primary outcome was the incidence of hypoglycemia.ResultsBefore QCC implementation, the incidence of hypoglycemia was 6.63%. Following the introduction of QCC interventions, the incidence significantly decreased to 2.94% (p<0.01). Monthly data revealed a continuous decline in hypoglycemia incidence, with rates dropping from 4.12% in June to 1.47% in November, and the results are statistically significant (p<0.001). Other confounding factors, including age, gender, education level, diabetes history, polyp size, site, and fasting duration, were not significantly associated with the outcome (p>0.05).ConclusionThis study effectively reduced the incidence of hypoglycemia in patients following endoscopic polypectomy through the implementation of QCC activities, significantly enhancing patient safety and treatment outcomes. The successful implementation of the project validated the important role of QCC in continuous quality improvement, providing valuable experience and methods for future clinical nursing management.
- Research Article
- 10.1016/j.artmed.2025.103167
- Sep 1, 2025
- Artificial intelligence in medicine
- Malik Abdul Manan + 3 more
Enhancing colorectal polyp segmentation with TCFMA-Net: A transformer-based cross feature and multi-attention network.
- Research Article
- 10.2500/aap.2025.46.250050
- Sep 1, 2025
- Allergy and asthma proceedings
- Anju T Peters + 10 more
Background: Systemic corticosteroids (SCS) are widely used to treat patients with chronic rhinosinusitis with nasal polyps (CRSwNP) that is insufficiently controlled with first-line treatments. However, such treatment must be balanced against the risk of adverse effects with protracted or repeated use. Increasing awareness of these adverse effects and the introduction of biologics are changing established management approaches. Objective: The objective was to review the role of SCS in the management of CRSwNP in the evolving treatment landscape. Methods: A literature search was conducted for salient articles on SCS in CRSwNP, including guidelines. Results: SCS reduce inflammation through broad actions on various immune mediators. Short courses of SCS improve symptoms (especially olfactory function) and reduce polyp size, benefits that do not persist long-term after treatment ends. SCS are widely used before endoscopic sinus surgery to improve the visibility of the surgical field and after surgery to improve outcomes, although evidence for benefit of postsurgical SCS is lacking. Adverse effects associated with SCS can manifest in a wide range of organs and systems. Use of SCS in patients with CRSwNP is associated with an increased risk of avascular necrosis, pneumonia, obesity, anxiety and/or depression, fracture, sleep apnea, hypothalamic-pituitary-adrenal axis suppression, diabetes, and hypertension. The SCS dosage regimen for CRSwNP is not well defined, and there is wide variation in clinical practice. Clinical guidelines refer to "short courses" of SCS but provide minimal guidance and lack consensus. Biologic treatments for CRSwNP have well-documented steroid-sparing effects, but the extent to which biologics might be able to reduce the use of or replace SCS may depend on economics as well as relative benefit-to-risk ratios. Conclusion: Short courses of SCS are widely used in patients with CRSwNP, but their use must be balanced against the risk of adverse effects. Use of biologics may reduce the use of SCS in CRSwNP, minimizing these adverse effects.
- Research Article
- 10.1177/26317745251370845
- Aug 30, 2025
- Therapeutic Advances in Gastrointestinal Endoscopy
- Ian Io Lei + 6 more
Background:Colorectal cancer (CRC) incidence is rising globally, intensifying pressure on endoscopy services. Colon capsule endoscopy (CCE) offers a non-invasive alternative. Despite several systematic reviews showing reasonable polyp detection rates, clinical scepticism remains.Objectives:This meta-review and umbrella meta-analysis aim to synthesise evidence on CCE’s diagnostic accuracy in polyp and CRC detection, using CT colonography or colonoscopy as the reference standard.Methods:We conducted a systematic search of EMBASE, MEDLINE and PubMed for systematic reviews evaluating the diagnostic accuracy of CCE in detecting polyps and CRC. A qualitative thematic review and synthesis were conducted following PRISMA guidelines. A bivariate generalised linear mixed model with random effects was used for pooled diagnostic accuracy estimates, and meta-regression was performed using restricted maximum likelihood estimation.Results:Nine systematic reviews encompassing 28 unique studies (3472 participants) were included. For polyps of any size, the pooled per-patient sensitivity was 0.79 (95% CI: 0.69–0.86), specificity was 0.77 (95% CI: 0.71–0.82), and the area under the curve (AUC) was 0.81. For polyps ⩾6 mm, sensitivity and specificity were 0.80 and 0.87 (AUC 0.81), and for polyps ⩾10 mm, 0.88 and 0.95 (AUC 0.95), respectively. Second-generation CCE (CCE2) improved diagnostic accuracy across all polyp sizes. For polyps of any size, CCE2 achieved a sensitivity of 0.90, specificity of 0.81 and AUC of 0.82. For polyps ⩾ 6 mm and ⩾10 mm, AUCs were 0.92 and 0.94, respectively. CCE2 showed high sensitivity for detecting any polyp size and polyps ⩾6 mm, with low heterogeneity (p > 0.05, I2 < 25%). CRC detection sensitivity was 0.96 (95% CI: 0.73–1.00) after excluding cases where the capsule failed to reach the rectum due to battery exhaustion.Conclusion:CCE2 has high diagnostic accuracy for polyps and colorectal cancer detection. While technical challenges persist, CCE2 shows promise as a complementary diagnostic tool to help address the increasing demands for endoscopy services.
- Research Article
- 10.4240/wjgs.v17.i8.108669
- Aug 27, 2025
- World Journal of Gastrointestinal Surgery
- Hui-Hui Yan + 7 more
BACKGROUNDPatients with early oral intake after intestinal surgery achieve better nutritional status and fewer postoperative complications. However, no guidelines or expert consensus have established the optimal timing for diet resumption following colorectal polypectomy.AIMTo determine the timing, feasibility, and clinical benefits of early diet resumption following colorectal polypectomy.METHODSIn the Second Affiliated Hospital of Zhejiang University School of Medicine, a total of 1502 patients with polyps under 3 cm were recruited and randomly assigned to an experimental group (n = 751) and a control group (n = 751). Following polypectomy, the experimental group consumed rice soup at 2 hours, while the control group received rice soup at 6 hours. The study focused on delayed post-polypectomy bleeding (DPPB), with secondary evaluation of post-polypectomy perforation, hypoglycemia, fever, and length of stay (LOS).RESULTSThe comparison between the two groups revealed no significant differences in DPPB rates (4.7% vs 5.5%, P = 0.480) and major bleeding rates (1.5% vs 2.1%, P = 0.332). Both groups displayed median bleeding times of 2 days. No notable differences in perforation (0.0% vs 0.3%, P = 0.479) and fever rates (2.1% vs 2.9%, P = 0.324) were observed between the two groups. However, the experimental group showed significantly lower incidence of hypoglycemia (0.4% vs 1.5%, P < 0.05) and shorter LOS [1 (1, 2) day vs 2 (1, 2) days, P < 0.001] following polypectomy. Subgroup analyses further confirmed that early diet resumption had no adverse effects on patients, irrespective of polyp count, size, pathology, or polypectomy modalities.CONCLUSIONEarly diet resumption following colorectal polypectomy for polyps not exceeding 3 cm is advisable as it does not significantly increase the risk of complications.
- Research Article
- 10.1111/liv.70312
- Aug 26, 2025
- Liver international : official journal of the International Association for the Study of the Liver
- Johannes Altenmüller + 12 more
In primary sclerosing cholangitis (PSC), the risk for gallbladder malignancy is increased. Surveillance imaging is used for early diagnosis. The study aims to assess the reliability of ultrasound and magnetic resonance imaging (MRI) for the detection of gallbladder polyps in people with PSC and to define a polyp size as a cut-off at which cholecystectomy is indicated due to the high probability of a malignant finding. In this retrospective European multicentre study, we included 51 people with PSC who had cholecystectomy for gallbladder polyps detected on imaging using ultrasound and/or MRI within 6 months prior to cholecystectomy and a histology report available. As a control group, we included 102 people with PSC with other indications for cholecystectomy. Malignancy was defined as high-grade dysplasia or carcinoma on histology. Including all 153 patients, ultrasound was significantly more sensitive than MRI in detecting gallbladder polyps (p < 0.001). MRI missed 3 of the 8 malignant polyps. Malignant polyps (n = 8, median size = 12.5 mm) were significantly larger than non-malignant polyps (n = 26, median size = 6 mm) on ultrasound (p < 0.001). Ultrasound detected malignant polyps reliably (AUC = 0.91, p < 0.001) with an optimal cut-off of 8 mm. This cut-off was defined in the Hamburg cohort and validated in a multicentre validation cohort with an AUC of 0.92 (p = 0.02). Ultrasound is more sensitive for the detection of gallbladder polyps than MRI in people with PSC. The best cut-off to differentiate between benign and malignant polyps was 8 mm. Ultrasound (gallbladder) and MRI (bile ducts) may thus be complementary methods for hepatobiliary malignancy surveillance in people with PSC.
- Research Article
- 10.1158/2767-9764.crc-25-0182
- Aug 19, 2025
- Cancer Research Communications
- Jun Li + 7 more
The accumulation of pathogenic mutations in premalignant colorectal neoplasms is critical for colorectal cancer development; however, the frequency and diversity of pathogenic driver mutations in early-stage colorectal polyps is incompletely known. We investigated this by whole-exome sequencing of low-grade dysplasia (LGD) colorectal polyps and paired germline DNA. Interestingly, in these early lesions, there was no association with mutational burden and the known risk factor of polyp size (range, 3–15 mm). However, a subset of LGD polyps harbored concurrent, oncogenic alterations in colorectal cancer–causing pathways of WNT/β-catenin, p53, or RTK-RAS. Further analysis suggested that the concurrent mutation signature was associated with increased polyp burden. Spatial transcriptomic analysis revealed that immune effectors, including NF-κB signaling, were a characteristic of LGD polyps with concurrent pathogenic mutations. Together, these observations suggest that some small-sized, early colorectal neoplasms have enhanced oncogenic potential and highlight that nonadvanced colorectal adenoma may not be universally considered a low-risk finding.Significance:Through whole-exome sequencing of early colorectal polyps characterized by LGD, we demonstrate that polyp size poorly correlates with mutational burden. Some small-sized (<10 mm polyps) early polyps harbored concurrent driver gene mutations commonly seen in adenocarcinoma. Sequencing of key driver genes in early polyps may identify risky lesions that cannot be detected by histology alone.
- Research Article
- 10.1001/jama.2025.12515
- Aug 18, 2025
- JAMA
- Shen Shen + 28 more
Chronic rhinosinusitis with nasal polyps causes severe symptoms and impaired quality of life. Stapokibart is a novel monoclonal antibody that targets interleukin 4Rα. To assess the efficacy and safety of stapokibart as an add-on treatment to intranasal corticosteroids in patients with severe uncontrolled chronic rhinosinusitis with nasal polyps. From August 9, 2022, to April 28, 2023, this randomized, double-blind, phase 3 clinical trial, conducted at 51 hospitals in China, enrolled adult patients with chronic rhinosinusitis with nasal polyps who had a history of systemic corticosteroid use or sinonasal surgery and a bilateral nasal polyp score of 5 or greater (on a scale of 0-8) and a weekly mean nasal congestion score of 2 or greater (on a scale of 0-3). Eosinophilic chronic rhinosinusitis with nasal polyps was defined as blood eosinophils of 6.9% or greater (without asthma) or 3.7% or greater (with asthma) or an eosinophil count of 55 per high-power field or greater or 27% or greater in nasal polyp tissue. Patient follow-up was completed on June 25, 2024. Four weeks after initiation of mometasone furoate nasal spray, 100 µg in each nostril daily, patients were randomized to receive subcutaneous stapokibart, 300 mg, or placebo (1:1) every 2 weeks for 24 weeks. Both groups then received stapokibart for 28 weeks. Co-primary end points were changes from baseline in nasal polyp score (meaningful change threshold [MCT] ≥1 point) and nasal congestion score (MCT ≥0.5 points) at week 24 in all patients and in the population with eosinophilia. Among 180 patients randomized, 179 (mean age, 45 [SD, 12.9] years; 61 [34.1%] women) received at least 1 treatment dose (n = 90 for stapokibart; n = 89 for placebo). In the overall population, the least-squares (LS) mean change in nasal polyp score from baseline to week 24 in the stapokibart vs placebo groups was -2.6 vs -0.3 points, respectively, (LS mean difference, -2.3; 95% CI, -2.6 to -1.9; P < .001); in the population with eosinophilia, the change was -3.0 vs -0.4 points, respectively (LS mean difference, -2.5; 95% CI, -2.9 to -2.1; P < .001). The LS mean change in nasal congestion score from baseline to week 24 in the stapokibart vs placebo groups was -1.2 vs -0.5 points, respectively, in the overall population (LS mean difference, -0.7; 95% CI, -0.9 to -0.5; P < .001) and -1.3 vs -0.5 points, respectively, in the population with eosinophilia (LS mean difference, -0.8; 95% CI, -1.0 to -0.6; P < .001). Serious adverse events were rare (2.2% in the stapokibart group vs 1.1% in the placebo group). Higher rates of arthralgia (7.8% vs 0%) and hyperuricemia (5.6% vs 1.1%) were reported with stapokibart vs placebo, respectively. Among patients with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, stapokibart reduced polyp size and severity of nasal symptoms at 24 weeks. ClinicalTrials.gov Identifier: NCT05436275.
- Research Article
- 10.1016/j.jvoice.2025.08.003
- Aug 1, 2025
- Journal of voice : official journal of the Voice Foundation
- Mohamed Baraka + 1 more
Effectiveness of Vocal Hygiene Advice in Managing Hemorrhagic Vocal Fold Polyps of Varying Sizes.