Transformation Zone Type Research Articles

Terminology for cone dimensions after local conservative treatment for cervical intraepithelial neoplasia and early invasive cervical cancer: 2022 consensus recommendations from ESGO, EFC, IFCPC, and ESP.

Local cervical treatment for squamous intraepithelial lesion (SIL) or cervical intraepithelial neoplasia (CIN) removes or ablates a cone-shaped or dome-shaped part of the cervix that contains abnormal cells. This Series paper introduces the 2022 terminology for cone dimensions after local conservative treatment for SIL, CIN, or early invasive cervical cancer. The terminology was prepared by the Nomenclature Committee of the European Society of Gynaecologic Oncology, the European Federation for Colposcopy, the International Federation of Cervical Pathology and Colposcopy, and the European Society of Pathology. Cone length should be tailored to the type of transformation zone. Treatment of SIL or CIN is associated with an increased risk of preterm birth, which escalates with increasing cone length. There is a lack of agreement regarding terms used to report excised specimen dimensions both intraoperatively and in the pathology laboratory. Consensus is needed to make studies addressing effectiveness and safety of SIL or CIN treatment comparable, and to facilitate their use to improve accuracy of antenatal surveillance and management. This Series paper summarises the current terminology through a review of existing literature, describes new terminology as agreed by a group of experts from international societies in the field of cervical cancer prevention and treatment, and recommends use of the new terminology that will facilitate communication between clinicians and foster more specific treatment guidelines that balance obstetrical harm against therapeutic effectiveness.

Clinical utility of p16/Ki67 dual-stain cytology for detection of cervical intraepithelial neoplasia grade two or worse in women with a transformation zone type 3: A cross-sectional study.

To evaluate the clinical utility of p16/Ki67 dual-stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3). Cross-sectional study. Colposcopy clinics in Central Denmark Region. Women aged 45 years or older referred for colposcopy because of an abnormal screening test. All women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ). Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology. Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p=0.021) and NPV (97.6% versus 86.4%, p=0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p=0.001) were lower for DS compared with cytology. Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.

Photodynamic therapy for early cervical cancer.

e17528 Background: Photodynamic therapy (PDT), with its high efficiency and selective impact on tumor cells without damaging healthy tissues, is an organ-sparing treatment preserving the anatomy and function of the cervix. Preservation of the reproductive function is the most significant criterion for the efficacy of an organ-sparing treatment. The purpose of this study was to evaluate the efficacy of PDT for early cervical cancer. Methods: PDT results were studied in 74 patients aged 18-40 years with early cervical cancer. The patients were divided into 3 groups depending on the type of transformation zone (TZ), the degree of invasion and the tumor site: group 1 - 36 patients with preinvasive cancer in the exocervix (TZ type I-II); group 2 - 34 patients with preinvasive cancer in the endocervix (TZ type III); group 3 - 4 patients with microinvasive cancer T1a1N0M0 with invasion of no more than 1 mm as an alternative to surgical intervention. Infection with high-risk genotypes of HPV (16, 18, 31, 33, 35, 45, 56) was detected with PCR in 62 (84%) women. All patients received PDT with the semiconductor Latus laser up to 3 W, a single-use diffusing fiber for the exocervix irradiation and a single-use cylindrical diffusing fiber for tumors in the cervical canal. Chlorin e6 was used as a photosensitizer. The efficiency criteria included the normalization of the colposcopic and morphological picture, and the HPV elimination confirmed by the PCR test. 4 to 8 procedures were required to restore the normal layer of stratified squamous epithelium. Results: PDT was followed by direct photocoagulation necrosis caused by the destruction of cellular structures, and ischemic necrosis as a result of damage and destruction of the microvasculature of the initial tumor changes in the cervical epithelium. Epithelialization of the cervix was completed by days 35-40. Normal morphological picture was observed in 96% of patients in group 1 and in 95% of patients in group 2; all patients in group 3 had a pronounced positive response. PCR 3 months after PDT showed a positive HPV reaction in 5.1% of patients. No negative changes in the cytogram were detected 6 and 12 months after PDT. The maximum follow-up period has lasted for 5.1 years. No relapses of the disease have been registered. During the follow-up period, four patients with preinvasive cancer and one patient with microinvasive cancer successfully gave birth to healthy children. Conclusions: PDT is an alternative treatment for precancerous and early malignant tumors of the cervix; it preserves the anatomical and functional integrity of the organ, which is important for the female reproductive function. The results of the study allow recommending PDT in the treatment of early cervical cancer.

Cervical intraepithelial neoplasia in women with transformation zone type3: cervical biopsy versus large loop excision.

To compare the proportion of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in cervical biopsies with that in large loop excision of the transformation zone (LLETZ) specimens in women aged ≥45 years with transformation zone type 3 (TZ3). Multicentre cross-sectional study. Three colposcopy clinics in the Central Denmark Region. Women aged ≥45 years referred to colposcopy as a result of a positive human papillomavirus (HPV) test and/or abnormal cytology and with TZ3 at colposcopy. Women had multiple biopsies taken and an LLETZ was performed. Histologically confirmed CIN2+ in biopsies compared with that in LLETZ specimens. Of 166 eligible women at colposcopy, 102 women with paired data from biopsies and LLETZ specimens were included for final analysis. The median age was 67.7 years (IQR 62.6-70.4 years), and most were postmenopausal (94.1%) and had undergone HPV-based screening (81.3%). The CIN2+ detection rate was significantly higher in LLETZ specimens than in biopsies (32.4% vs 14.7%, difference 17.7%, 95%CI 6.3-29.0%), resulting in more than half of CIN2+ cases being missed in biopsies (54.5%, 95%CI 36.4-71.9%). The overall agreement between biopsies and LLETZ was 82.4% (95%CI 73.6-89.2%). CIN2+ detection is underestimated in women aged ≥45 years with TZ3 if detection relies on the results of biopsies alone. To reduce the risk of underdiagnosis and overtreatment, future studies should explore the use of new biomarkers for risk stratification to improve discrimination between women at increased risk of CIN2+ who need to undergo LLETZ and women who may undergo follow-up.

Improving colposcopic accuracy for cervical precancer detection: a retrospective multicenter study in China

BackgroundColposcopy alone can result in misidentification of high-grade squamous intraepithelial or worse lesions (HSIL +), especially for women with Type 3 transformation zone (TZ) lesions, where colposcopic assessment is particularly imprecise. This study aimed to improve HSIL + case identification by supplementing referral screening results to colposcopic findings.MethodsThis is an observational multicenter study of 2,417 women, referred to colposcopy after receiving cervical cancer screening results. Logistic regression analysis was conducted under uni- and multivariate models to identify factors which could be used to improve HSIL + case identification. Histological diagnosis was established as the gold standard and is used to assess accuracy, sensitivity, and specificity, as well as to incrementally improve colposcopy.ResultsMultivariate analysis highlighted age, TZ types, referral screening, and colposcopists’ skills as independent factors. Across this sample population, diagnostic accuracies for detecting HSIL + increased from 72.9% (95%CI 71.1–74.7%) for colposcopy alone to 82.1% (95%CI 80.6–83.6%) after supplementing colposcopy with screening results. A significant increase in colposcopic accuracy was observed across all subgroups. Although, the highest increase was observed in women with a TZ3 lesion, and for those diagnosed by junior colposcopists.ConclusionIt appears possible to supplement colposcopic examinations with screening results to improve HSIL + detection, especially for women with TZ3 lesions. It may also be possible to improve junior colposcopists’ diagnoses although, further psychological research is necessary. We need to understand how levels of uncertainty influence diagnostic decisions and what the concept of “experience” actually is and what it means for colposcopic practice.

The value of the endocervical margin status in LEEP: analysis of 610 cases.

To describe the results of 610 patients who underwent LEEP and evaluate factors related to a negative margin. A retrospective study of patients treated by LEEP at a colposcopy referral service in Campinas, Brazil, 2017-2019. Patients were referred to treat high-grade squamous intraepithelial lesion or adenocarcinoma in situ suspected by cytology and colposcopy (screen-and-treat) or by biopsy. Descriptive analysis was performed by frequencies as a function of the status of the margins (negative or positive). Factors associated with margin status were assessed by regression. The endocervical, ectocervical or both margins were negative in 82.4%, 75.7% and 65.9%, respectively. Age, sexual debut, parity, menopause status, smoking and hormonal contraception showed no difference in the proportion of negative margins. Both margins were negative in 66.1% of patients with transformation zone type(TZ) 1, 73.1% of TZ 2, and 54.7% of TZ 3 (p = 0.015). The endocervical negative margin was obtained in 78.0% of patients submitted to excision I (loop 10mm) and 82.5% to excision II (loop 15mm) (p = 0.016). Having the sexual debut at 18years or older or being submitted to an excision type II doubled the chance of negative endocervical margin (1.98;1.04-3.77 and 1.95; 1.18-3.21, respectively). The proportion of negative endocervical margin was 78% in excision I and 86% in excision II. Sexual onset and excision type II increased the chance of obtaining a negative endocervical margin.

Assessing colposcopic accuracy for high\u2010grade squamous intraepithelial lesion detection: a retrospective, cohort study

BackgroundInappropriate management of high-grade squamous intraepithelial lesions (HSIL) may be the result of an inaccurate colposcopic diagnosis. The aim of this study was to assess colposcopic performance in identifying HSIL+ cases and to analyze the associated clinical factors.MethodsRecords from 1130 patients admitted to Shenzhen Maternal and Child Healthcare Hospital from 12th January, 2018 up until 30th December, 2018 were retrospectively collected, and included demographics, cytological results, HPV status, transformation zone type, number of cervical biopsy sites, colposcopists’ competencies, colposcopic impressions, as well as histopathological results. Colposcopy was carried out using 2011 colposcopic terminology from the International Federation of Cervical Pathology and Colposcopy. Logistic regression modelling was implemented for uni- and multivariate analyses. A forward stepwise approach was adopted in order to identify variables associated with colposcopic accuracy. Histopathologic results were taken as the comparative gold standard.ResultsData from 1130 patient records were collated and analyzed. Colposcopy was 69.7% accurate in identifying HSIL+ cases. Positive predictive value, negative predictive value, sensitivity and specificity of detecting HSIL or more (HSIL+) were 35.53%, 64.47%, 42.35% and 77.60%, respectively. Multivariate analysis highlighted the number of biopsies, cytology, and transformation zone type as independent factors. Age and HPV subtype did not appear to statistically correlate with high-grade lesion/carcinoma.ConclusionEvidence presented here suggests that colposcopy is only 69.7% accurate at diagnosing HSIL. Even though not all HSIL will progress into cancer it is considered pre-cancerous and therefore early identification will save lives. The number of biopsies, cytology and transformation zone type appear to be predictors of misdiagnosis and therefore should be considered during clinical consultations and by way of further research.

The distribution and pathogenic risk of non-9-valent vaccine covered HPV subtypes in cervical lesions.

Human papillomavirus (HPV) infection is the main cause of female precancerous lesions and cervical cancer. The development and application of HPV prophylactic vaccines have been recognized as a major effective intervention for the control of cervical lesions. However, the infection rate and clinical characters of non‐9‐valent vaccine covered HPV subtypes are still worth studying. In this retrospective study, we included patients diagnosed and treated in the Department of Gynecology of Shanghai General Hospital between January 2017 and February 2021. The clinical features of non‐9‐valent vaccine covered HPV subtypes were explored in 2179 patients who have normal results, 338 patients with cervical intraepithelial neoplasia 1 (CIN1), and 153 patients with ≥CIN2. Univariate analysis showed that compared to the normal cervix group, age ≥50, pregnancy ≥5, delivery ≥3, menopause, no condom use, and cervical transformation zone type III were risk factors for CIN1 or ≥CIN2 (p < 0.05). Thirty‐one percent of CIN1 and 26% of ≥CIN2 were attributed to HPV51, HPV53, HPV56, and HPV68. Multivariate analysis revealed that HPV53, HPV81, age, menopause, cervical transformation area and involved glands were independent risk factors for ≥CIN2 group compared to the CIN1 group (p < 0.05). Additionally, among the 14 non‐9‐valent vaccine covered HPV subtypes, the infection rates of HPV53, 56, 51, and 68 were higher in this study. In conclusion, our study demonstrated the distribution and pathogenic risk of non‐9‐valent vaccine covered HPV subtypes in cervical lesions. These findings might supply a foundation for optimizing cervical cancer prevention in the post‐vaccine era.

The use of biomarkers and HPV genotyping to improve diagnostic accuracy in women with a transformation zone type 3.

Twenty percent of women referred to colposcopy have a type 3 transformation zone-where colposcopic assessment for high-grade dysplasia (CIN2+) is not possible. This study examines the effectiveness of HPV biomarkers and genotyping in combination with techniques that sample an endocervical TZ. A prospective diagnostic accuracy study. Women booked for large-loop excision (LLETZ) with squamous dyskaryosis, high-risk HPV and a TZ3 were recruited. Immediately prior to LLETZ samples were collected for p16/Ki-67 dual-stained cytology, HPV genotyping and H&E, p16- and Ki-67-stained endocervical curettings. In women with low-grade screening (n = 64), 35.9% had CIN2+; dual-stained cytology had the greatest effect on the PPV of routine screening (76.1% vs 35.9%) and perfectly predicted the absence of CIN2+. Inwomen with a high-grade screening result (n = 37); 75.6% had CIN2+ and dual-stained curettings improved the PPV (96.5 vs 75.6%). With high-grade screening and a TZ3, LLETZ appears safest as three quarters have CIN2+ . Women with low-grade screening and a TZ3 have a twofold increased risk of CIN2+ when compared to women where the TZ is visible. The use of dual-stained cytology may help identify those women who can be safely offered surveillance and those who require treatment.

Necessity for subsequent surgery in women of child-bearing age with positive margins after conization

Background20–25% of women with high-grade cervical intraepithelial neoplasias (HSIL) have residual lesions after conization. The state of the margin is generally considered to be a risk factor for recurrence or persistent lesions. Predictors of positive margins and residual lesions need to be identified. A design for postoperative management and avoidance of overtreatment needs to be provided, especially for women of child-bearing age.MethodsThis study was a retrospective analysis of 1309 women of child-bearing age with HSIL, who underwent cold knife conization (CKC). Age, gravidity, parity, human papillomavirus (HPV) species, cytology, transformation zone type, results of endocervical curettage (ECC), quadrant involvement, glandular involvement, and Cervical Intraepithelial Neoplasia (CIN) grade were analyzed. Among those with positive margins, 245 patients underwent secondary surgery within three months, including CKC, a loop electrosurgical excision procedure, and total hysterectomy. Risk factors for positive margins and residual lesions were assessed.ResultsThere was no significant difference in age, gravidity, parity, glandular involvement, and CIN grade between the two groups (P > 0.3). There was a significant difference in HPV species, cytology, ECC results, and quadrant involvement (P < 0.002). Multivariate analysis showed a major cytology abnormality, high-risk HPV infection, type III transformation zone, positive ECC result, and multiple quadrant involvement were independent risk factors for positive margins and residual lesions (P < 0.02). Age > 35 years was also a risk factor for residual lesions (P < 0.03).ConclusionHigh-risk women should be treated appropriately considering fertility. Patients with positive margins should be managed uniquely. Surgery for women without fertility may be appropriate. Close follow-up is necessary for women who have fertility requirements or are unwilling to undergo subsequent surgery if they have no risk factors, especially women < 35 years.

Analysis of the agreement between colposcopic impression and histopathological diagnosis of cervical biopsy in a single tertiary center of Chengdu

The aim of this retrospective study was to analyze the agreement between colposcopic impression and histopathological diagnosis of cervical biopsy. The medical records of patients underwent a colposcopy-guided cervical biopsy at Chengdu Women's and Children's Central Hospital between January 2017 and January 2019 were collected, including age, menopausal status, cervical cytology and human papillomavirus (HPV) test results, type of transformation zone, colposcopic diagnosis and histopathological outcomes of cervical biopsy. Colposcopy was carried out using 2011 colposcopic terminology of International Federation for Cervical Pathology and Colposcopy (IFCPC). Related variables were analyzed. A total of 495 patients were collected in this study. The perfect agreement between colposcopic impression and histopathological diagnosis was 46.9%, and the strength of agreement with kappa value was 0.283 (P < 0.001), and the agreement within 1 grade was 93.5%. Positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, false-positive rate and false-negative rate of detecting HSIL or more (HSIL +) were 93.1%, 57.8%, 80.9%, 93.9%, 6.1% and 45.3%, respectively. Colposcopic diagnosis more often underestimated (43.2%) [especially in HSIL (59.3%) and carcinoma (70.7%) patients] than overestimated (9.9%) in cervical lesions. The results of cytology, HPV status, patients' age and different experiences of practitioners were the factors for under-diagnosis of HSIL + by colposcopy. Colposcopy is an excellent tool to estimate cervical high-grade lesion but is imprecise. Many factors can bias the diagnosis of colposcopy, especially the known results of cervical cytology and HPV. Precise diagnosis of cervical lesion should rely on the colposcopy-directed biopsy.

Factors Correlated with the Accuracy of Colposcopy-Directed Biopsy: A Systematic Review and Meta-Analysis

Purpose/aim of the study Colposcopy-directed cervical biopsy has played a major role in diagnosing cervical lesions. The precision of colposcopy-guided biopsy has been questioned. We analyzed several factors that may be correlated with the accuracy of biopsy. Methods PubMed, EMBASE were searched from January 1, 1998 to March 1, 2020. Odds ratio with 95% confidence intervals (CIs) were calculated. Selection criteria Included studies evaluated factors correlated with the accuracy of biopsy and patients’ final diagnosis was established by histological examination of the specimen obtained by conization, loop electrosurgical excision procedure (LEEP), or colpohysterectomy. Results A total of 10 studies were selected for the systematic review and meta-analysis. The pooled analysis indicated that the diagnostic inaccuracies of colposcopy-directed cervical biopsy were magnified in women who were 50 years of age or older. Postmenopausal status and transformation zone 3 type were also associated with the diagnostic inaccuracies of colposcopy-directed biopsy. High-grade squamous intraepithelial lesions had better concordance rates than low-grade squamous intraepithelial lesions. The number of vaginal deliveries, number of biopsies, and HPV type were associated with biopsy underdiagnosis and biopsy overestimation. Conclusions This meta-analysis found that the correlation between the histological findings at biopsy and after surgical treatment was influenced by women’s age, menopausal status, and the transformation zone type. The diagnostic efficacy was also better for high-grade squamous intraepithelial lesions than for low-grade squamous intraepithelial lesions. Further large-scale randomized clinical trials are required to analyze the factors correlated with biopsy underdiagnosis and biopsy overestimation.

Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial

Loop electrosurgical excision procedure may be performed under local anesthesia or general anesthesia, and practice patterns differ worldwide. No randomized head-to-head comparison has been published to confirm or refute either practice. This study aimed to compare loop electrosurgical excision procedure under local anesthesia vs general anesthesia regarding patient satisfaction and procedure-related outcomes such as rates of involved margins, complications, pain, and blood loss. Consecutive women referred to our colposcopy unit were recruited. Loop electrosurgical excision procedure was performed under local anesthesia with 4 intracervical injections of bupivacaine hydrochloride 0.5% or under general anesthesia with fentanyl, propofol, and a laryngeal mask with sevoflurane maintenance. The primary endpoint was patient satisfaction assessed on the day of surgery and 14 days thereafter using a Likert scale (score 0-100) and a questionnaire. Secondary endpoints included rates of involved margins, procedure-related complications, pain, blood loss, and surgeon preference. Results were compared using nonparametric and chi-square tests. Between July 2018 and February 2020, we randomized 208 women, 108 in the local anesthesia arm and 100 in the general anesthesia arm. In the intention-to-treat analysis, patient satisfaction did not differ between the study groups directly after surgery (Likert scale 100 [90-100] vs 100 [90-100]; P=.077) and 14 days thereafter (Likert scale 100 [80-100] vs 100 [90-100]; P=.079). In the per-protocol analysis, women in the local anesthesia arm had significantly smaller cone volumes (1.11 cm3 [0.70-1.83] vs 1.58 cm3 [1.08-2.69], respectively; P<.001), less intraoperative blood loss (Δhemoglobin, 0.2 g/dL [-0.1 to 0.4] vs 0.5 g/dL [0.2-0.9]; P<.001), and higher satisfaction after 14 days (100 [90-100] vs 100 [80-100]; P=.026), whereas surgeon preference favored general anesthesia (90 [79-100] vs 100 [90-100], respectively; P=.001). All other secondary outcomes did not differ between groups (resection margin status R1, 6.6% vs 2.1% [P=.26]; cone fragmentation, 12.1% vs 6.3% [P=.27]; procedure duration, 151.5 seconds [120-219.5] vs 180 seconds [117-241.5] [P=.34]; time to complete hemostasis, 60 seconds [34-97] vs 70 seconds [48.25-122.25] [P=.08]; complication rate, 3.3% vs 1.1% [P=.59]). In a multivariate analysis, parity (P=.03), type of transformation zone (P=.03), and cone volume (P=.02) and not study group assignment, age, body mass index, and degree of dysplasia independently influenced the primary endpoint. Loop electrosurgical excision procedure under local anesthesia is equally well tolerated and offers patient-reported and procedure-related benefits over general anesthesia, supporting the preferred practice in some institutions and refuting the preferred practice in others.

The application of deep learning based diagnostic system to cervical squamous intraepithelial lesions recognition in colposcopy images

Background Deep learning has presented considerable potential and is gaining more importance in computer assisted diagnosis. As the gold standard for pathologically diagnosing cervical intraepithelial lesions and invasive cervical cancer, colposcopy-guided biopsy faces challenges in improving accuracy and efficiency worldwide, especially in developing countries. To ease the heavy burden of cervical cancer screening, it is urgent to establish a scientific, accurate and efficient method for assisting diagnosis and biopsy. Methods The data were collected to establish three deep-learning-based models. For every case, one saline image, one acetic image, one iodine image and the corresponding clinical information, including age, the results of human papillomavirus testing and cytology, type of transformation zone, and pathologic diagnosis, were collected. The dataset was proportionally divided into three subsets including the training set, the test set and the validation set, at a ratio of 8:1:1. The validation set was used to evaluate model performance. After model establishment, an independent dataset of high-definition images was collected to further evaluate the model performance. In addition, the comparison of diagnostic accuracy between colposcopists and models weas performed. Results The sensitivity, specificity and accuracy of the classification model to differentiate negative cases from positive cases were 85.38%, 82.62% and 84.10% respectively, with an AUC of 0.93. The recall and DICE of the segmentation model to segment suspicious lesions in acetic images were 84.73% and 61.64%, with an average accuracy of 95.59%. Furthermore, 84.67% of high-grade lesions were detected by the acetic detection model. Compared to colposcopists, the diagnostic system performed better in ordinary colposcopy images but slightly unsatisfactory in high-definition images. Implications The deep learning-based diagnostic system could help assist colposcopy diagnosis and biopsy for HSILs.

Candidate HPV genotypes not included in the 9-valent vaccine for prevention of CIN 2–3

ObjectivesTo identify the prevalence of human papillomavirus genotypes – as a single infection or co-infection – not included in the 9-valent (9v) HPV vaccine among women with cervical intraepithelial neoplasia...

The effect of different cervical transformation zone types on the colposcopic diagnosis of cervical intraepithelial neoplasia

The effect of different cervical transformation zone types on the colposcopic diagnosis of cervical intraepithelial neoplasia

Comparison of the Cervex-Brush alone to Cytobrush plus Cervex-Brush for detection of cervical dysplasia in women with a transformation zone type 3.

Twenty percent of colposcopic assessments are inadequate due to a type 3 transformation zone (TZ3). In the absence of colposcopic or histological assessment, subsequent management is guided by the referral screening test. In the UK, routine cervical screening is completed by a Cervex-Brush alone. This study examines the effectiveness of a Cytobrush in addition to a standard Cervex-Brush when used in TZ3 assessment. An 18-month diagnostic accuracy study in a single National Health Service (NHS) Trust. Women with a TZ3 booked for large loop excision of the transformation zone (LLETZ) with a referral cytology of high-risk HPV and squamous dyskaryosis were recruited. Immediately prior to LLETZ, a Cervex-Brush plus Cytobrush liquid-based cytology sample was taken. Presence of endocervical cells was compared. Predictability of high-grade cervical intra-epithelial neoplasia (CIN2+) was by blind standardised reporting of the LLETZ histology. One hundred and five women were recruited from a total eligible population of 153 cases (68.8%). Endocervical cell yield was increased with the Cervex-Brush plus Cytobrush when compared to the Cervex-Brush alone (99.1% vs 79.1%, P<.001). Irrespective of cytological grade, age or parity, there was no difference in predictability of CIN2+ between sampling methods. When compared to Cervex-Brush sampling alone, the addition of a Cytobrush improves endocervical sampling but does not improve cytological predictability of CIN2+ in women with a TZ3. These data suggest that women who will reliably attend for cytological follow-up can be safely referred to primary care for a Cervex-Brush alone.

Is routine ECC necessary in patients with HPV16 and normal cytology?

In the present study, we primarily aimed to correlate the colposcopy results of patients with human papillomavirus (HPV) positivity and abnormal cervical screening results. Secondarily, we attempted to define the role of endocervical curettage (ECC) in the colposcopic evaluation of patients who had normal cytology and HPV16, which is the most carcinogenic HPV type. This was a retrospective study analyzing the data of patients who had colposcopies between January 2015 and May 2016 in the Gynecological Oncology clinic of a single tertiary center. The data were evaluated to identify the pathologies in patients with HPV positivity and abnormal cervical screening results. A Colposcopic examination database was evaluated to obtain information regarding the cervical transformation zone (TZ), which was divided into three types by the International Federation for Cervical Pathology and Colposcopy. The binary variables were reported as counts and percentages. A total of 1049 patients were included in the analysis. The median age of the patients was 43 (range: 21-79). Cervical biopsies, ECC results, or both revealed cervical intraepithelial neoplasia 2+ (CIN2+: CIN2, CIN3, and invasive cancer) lesions in 22% (70/322) of the patients with HPV16 positivity, while this ratio was 8% (6/78) for patients with HPV18. CIN2+ lesions were detected in the 2.5% of patients with HPV positivity for types other than 16 and 18, as well as normal cytology. In the group of patients with HPV 16 and normal cytology, CIN2+ results were observed in the ECC of 11% of the patients whose colposcopy was normal regardless of the TZ type. Ten of the patients had invasive cancer. The current study provides evidence for the possible role of routine ECC in patients with HPV16, normal cytology, and a normal colposcopy.

Loop electrosurgical excision procedure with or without intraoperative colposcopy: a randomized trial

Loop electrosurgical excision procedure is the standard surgical treatment for cervical dysplasia. Loop electrosurgical excision procedure is advised to be performed under colposcopic guidance to minimize adverse pregnancy outcomes. To date, there is no evidence from randomized trials for this recommendation. We sought to assess the benefits of performing loop electrosurgical excision procedure under colposcopic guidance in women with cervical dysplasia. In a prospective, randomized trial, we compared loop electrosurgical excision procedure with loop electrosurgical excision procedure performed under direct colposcopic vision in a 1:1 ratio. The primary endpoint was resected cone mass; the secondary endpoints were margin status, fragmentation of the surgical specimen, procedure time, time to complete hemostasis, blood loss, and intraoperative and postoperative complications. A sample size of 87 per group (n= 174) was planned (with an assumed type I error of 0.05 and drop-out rate of 5%) to achieve 90% power to detect a 25% reduction in cone mass (with an assumed cone mass of 2.5 ± 1.6 g in the control group) using a nonparametric test (Mann-Whitney U). From October 2016 through December 2017, we randomized 182 women: 93 in the loop electrosurgical excision procedure group and 89 in the loop electrosurgical excision procedure-direct colposcopic vision group. Women undergoing loop electrosurgical excision procedure-direct colposcopic vision had significantly smaller cone specimens than those undergoing loop electrosurgical excision procedure (weight: median 1.86 [interquartile range 1.20-2.72] vs median 2.37 [interquartile range 1.63-3.31] g, respectively, P= .006). Secondary outcome measures did not differ significantly between groups: resection margin status involved vs free margin: 12 (13%) vs 75 (82%) and 11 (12.4%) vs 75 (84.3%); fragmentation no vs yes: 85 (92.4%) vs 7 (7.6%) and 84 (94.4%) vs 5 (5.6%); procedure time: 190 (interquartile range 138-294) and 171 (interquartile range 133-290) seconds; time to complete hemostasis: 61 (interquartile range 31-108) and 51 (interquartile range 30-81) seconds; intraoperative blood loss (Δhemoglobin): 0.4 (interquartile range 0.2-1.0) and 0.5 (interquartile range 0.1-0.9); complication rate: 6 (6.5%) and 2 (2.2%). In a multivariate analysis, study group allocation (P= .021) and parity (P= .028), but not age, body mass index, type of transformation zone, and dysplasia degree independently influenced the amount of resected cone mass. Loop electrosurgical excision procedure with intraoperative colposcopy leads to significantly smaller cone specimens without compromising margin status.

Clinical analysis of 128 cases of cervical lesion diagnosed by multi-point biopsy of colposcopy and endocervical curettage

Objective: To investigate the clinical values of colposcopy and cervical biopsy and/or endocervical curettage (ECC) in the diagnosis of cervical lesion. Methods: Clinical data of 128 cases of cervical lesion diagnosed by Xuzhou Cancer Hospital from January 23, 2014 to October 11, 2016 were collected and retrospectively analyzed, all patients underwent colposcopy and cervical biopsy and/or ECC. Results: Among them, the age between 30 to 50 years old were 70 cases, whose transformation zone types of Ⅰ, Ⅱ and Ⅲ were 28 cases (40.0%), 23 cases (32.9%) and 19 cases (27.1%), respectively. The age older than 50 years were 45 cases, whose transformation zone types of Ⅱ and Ⅲ were 1 case (2.2%) and 44 cases (97.8%), respectively. Among the 128 cases of cervical lesions, diagnostic results of colposcopy showed that the chronic inflammation were 57 cases, cervical intraepithelial neoplasia (CIN)Ⅰwere 35 cases, CINⅡor CINⅡ~Ⅲ were 8 cases, CIN Ⅲ were 5 cases and cervical cancer were 23 cases. Alternatively, the pathological results showed that the chronic inflammation were 81 cases, CINⅠwere 17 cases, CINⅡor CINⅡ~Ⅲ were 7 cases, CIN Ⅲ were 5 cases and cervical cancer were 18 cases, respectively. Among the 81 cases of chronic inflammation diagnosed by pathology, 52 cases (64.2%) were consistent with the diagnostic results of colposcopy. Among the 17 cases of low grade squamous epithelial cell lesion (LSIL) diagnosed by pathology, 10 cases were in agree with the diagnostic results of colposcopy. Among the 12 cases of high-grade squamous epithelial cell lesion (HSIL) diagnosed by pathology, 9 cases were concordant with the diagnostic results of colposcopy. Among the 18 cases of cervical cancer diagnosed by pathology, 17 cases were consistent with the diagnostic results of colposcopy. Conclusions: The type of transformation zone is positively correlated with the age, and it can help to choose biopsy and therapeutic manner. The diagnostic accuracies of HSIL and early stage of cervical cancer by multi-point biopsy of colposcopy and/or ECC are high. The cervical lesions which are difficultly found by direct visualization can be identified by colposcopy, and thus provides objective evidence to determine the therapeutic manner for patients with stage ⅡA of cervical cancer.