Transformation Zone Type Research Articles

Evaluation of a real-time optoelectronic method for the detection of cervical intraepithelial neoplasia and cervical cancer in patients with different transformation zone types

We aimed to evaluate the diagnostic value of TruScreen, a real-time diagnostic technology, for cervical lesions in patients with different transformation zone (TZ) types. A total of 1908 women aged 34.0 ± 7.3 years who have received cytology, human papillomavirus (HPV) testing, TruScreen, and colposcopy were recruited. The clinical performances of these tests were evaluated for their detection of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS), or more severe lesions in patients with different TZ types. For the detection of HSIL, AIS, or more severe lesions, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TruScreen were 65.08%, 64.76%,11.55%, and 96.33%, respectively, which were similar to cytology (all P values > 0.05). For the detection of HSIL + in patients with type 3 TZ, the sensitivity, specificity, PPV, and NPV of TruScreen were 72.29%, 67.59%, 13.86%, and 97.13%, respectively, which were significantly higher than the sensitivity (51.16%, P = 0.029), specificity (59.59%, P = 0.001), PPV (7.94%, P = 0.016), and NPV (94.71%, P = 0.049) in type 1 and type 2 TZs. TruScreen has detection accuracy comparable to cytology and performs even better in patients with type 3 TZ.

Evaluation of endocervical curettage (ECC) in colposcopy for detecting cervical intraepithelial lesions.

Diagnostic challenges in colposcopy arise especially in women aged 50 or older, with postmenopausal status and transformation zone type 3 (TZ3). Endocervical curettage (ECC) is a valuable tool for diagnosing intracervical lesions. The aim of this retrospective analysis was to evaluate the use of ECC in colposcopy for detecting cervical intraepithelial lesions. A retrospective study was carried out of colposcopies performed in the certified Dysplasia Unit at Erlangen University Hospital between July 2016 and June 2023. Pap and human papillomavirus (HPV) results were correlated with the histologic findings via ECC, obtained during examinations or surgery. The primary outcome was the rate of accuracy between the colposcopic and histologic findings with regard to cytology, age of patients, and type of transformation zone (TZ). A total of 429 colposcopies in 413 women with histologic samples obtained via ECC were included in the final analysis. In all, 355 women had TZ3. Among patients with TZ3, evidence of high-grade lesions and invasive carcinoma was also found in women with normal or low-grade abnormal cytology. For patients with normal colposcopic findings, cervical intraepithelial neoplasia (CIN) 2 and CIN3/adenocarcinoma in situ (AIS) were found in 56 patients (16%), and invasive carcinoma was found in four patients (0.1%). This analysis suggests that ECC is a valuable tool in the diagnosis of cervical intraepithelial neoplasia, especially for patients who present with a normal colposcopy of the cervix and vagina but have either recurrent abnormal cytologic findings or high-grade abnormal cytology indicating CIN2 + .

Analysis of factors affecting the accuracy of colposcopic diagnosis of cervical lesions: a retrospective cohort study.

Cervical cancer is a leading cause of cancer-related deaths among women. However, in developing countries, the primary focus for cervical cancer prevention and control remains on the timely detection and treatment of precancerous lesions. This study aims to evaluate the accuracy of colposcopic diagnosis of cervical intraepithelial lesions and analyze the factors influencing its accuracy. This study collected data from 512 eligible patients who visited the gynecology outpatient clinic of the Second Hospital of Jilin University from January 2022 to August 2023. The final diagnosis was based on the highest grade observed in both biopsy pathology and postoperative pathology. A self-controlled, retrospective analysis was conducted to evaluate the accuracy of colposcopic diagnosis. Univariate analysis was used to assess the impact of factors such as menopausal status, duration of menopause, high-risk human papillomavirus (HR-HPV) genotypes, and transformation zone (TZ) types on the accuracy of colposcopic diagnosis of cervical lesions. The overall colposcopy diagnostic concordance rate was 78.71%. The concordance rates between the premenopausal and postmenopausal groups differed significantly (χ 2 = 75.450, p < 0.05). The HPV16/18 positive group and the non 16/18 HR-HPV positive group also showed a significant difference in concordance rates (χ 2 = 5.890, p < 0.05). There were significant differences in concordance rates between TZ2 and TZ3 (χ 2 = 10.585, p < 0.05), as well as between TZ1 and TZ3 (χ 2 = 14.607, p < 0.05). Factors such as menopausal status, duration of menopause, HR-HPV genotypes, and TZ types influence the accuracy of colposcopic diagnosis. Therefore, a comprehensive evaluation incorporating these factors should be performed in clinical practice to enhance diagnostic accuracy.

Long-term follow-up of photodynamic therapy of cervical intraepithelial neoplasia grade 2 (CIN2)

BackgroundTo determine the long-term efficacy and safety of 5-aminolevulinic acid-based photodynamic therapy (ALA-PDT) for treating cervical intraepithelial neoplasia grade 2 (CIN2) as well as the suitability of ALA-PDT in treating of cervical lesions divided into cervical transformation zone type 3. MethodsWe included 81 patients diagnosed with CIN2 at the Department of Gynecology of the Affiliated Hospital of Qingdao University with data collected between January 2019 and January 2021 following ALA-PDT. Furthermore, we analyzed the superiority of ALA-PDT in fertility preservation among women of childbearing age based on follow-up data from 11 patients with fertility requirements. ResultsOur findings confirmed the long-term efficacy of ALA-PDT for CIN2 treatment, with an overall efficacy of 95.83 % (23/24) at follow-up of 25–36 months. Moreover, the cervical transformation zone type 3 improvement and human papillomavirus (HPV)-negative efficacy were 69.2 % (18/26) and 82.4 % (14/17), respectively. ALA-PDT is recommended for consenting patients with cervical transformation zone type 3. Additionally, women without primary infertility could experience natural pregnancy and full-term birth of more than one baby following ALA-PDT for CIN2 treatment, with a satisfaction rate of ≈100 %. ConclusionsALA-PDT is recommendable for treating high-grade squamous intraepithelial lesions, especially in patients with fertility requirements.

Evaluation of the diagnostic performance of colposcopy in the detection of cervical high-grade squamous intraepithelial lesions among women with transformation zone type 3

BackgroundInaccurate colposcopy diagnosis may lead to inappropriate management and increase the incidence of cervical cancer. This study aimed to evaluate the diagnostic accuracy of colposcopy in the detection of histologic cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women with transformation zone type 3 (TZ3).MethodsRecords from 764 patients with TZ3 who underwent colposcopy-directed biopsy and/or endocervical curettage in Putuo Hospital China between February 2020 and March 2023 were retrospectively collected. Colposcopy was carried out based on 2011 International Federation of Cervical Pathology and Colposcopy (IFCPC) and Colposcopy nomenclature. The diagnostic performance of colposcopy for identifying CIN2 + was evaluated compared with biopsies. The Kappa and McNemar tests were used to perform statistical analyses.ResultsAmong the study population, 11.0% had pathologic CIN2+. The relative sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of colposcopy for histologic CIN2 + were 51.2%, 96.5%, 64.2% and 94.1%, respectively. The senior colposcopists (80.6%) had a higher colposcopic accuracy to diagnose histologic CIN2 + than junior colposcopists (68.6%). In subgroup analyses, age group ≥ 60 years (70.3%) showed lowest diagnostic accuracy when compared with age groups of < 45 years (84.4%) and 45–59 years (74.9%).ConclusionOur findings suggest an increased risk of diagnostic inaccuracy of colposcopy in identifying CIN2 + in those ≥ 60 years of age with TZ3, and the accuracy of colposcopy is required to be further improved.

Knowledge of cytology results affects the performance of colposcopy: a crossover study

ObjectiveTo determine whether knowledge of cytology affects the colposcopist’s diagnostic accuracy in the identification of cervical intraepithelial neoplasia grade 2 and worse (≥ CIN2).MethodIn this cross-over study, healthcare professionals interpreted colposcopy images from 80 patient cases with known histological diagnoses. For each case, 2 images taken with a colposcope were provided (native and after acetic acid application). Inclusion criteria consisted of women with a transformation zone type 1 or 2, who had both a cytological and histological diagnosis. Cases were distributed across two online surveys, one including and one omitting the cytology. A wash-out period of six weeks between surveys was implemented. Colposcopists were asked to give their diagnosis for each case as < CIN2 or ≥ CIN2 on both assessments. Statistical analysis was conducted to compare the two interpretations.ResultsKnowledge of cytology significantly improved the sensitivity when interpreting colposcopic images, from 51.1% [95%CI: 39.3 to 62.8] to 63.7% [95%CI: 52.1 to 73.9] and improved the specificity from 63.5% [95%CI: 52.3 to 73.5] to 76.6% [95%CI: 67.2 to 84.0]. Sensitivity was higher by 38.6% when a high-grade cytology (ASC-H, HSIL, AGC) was communicated compared to a low-grade cytology (inflammation, ASC-US, LSIL). Specificity was higher by 31% when a low-grade cytology was communicated compared to a high-grade.ConclusionsOur data suggests that knowledge of cytology increases sensitivity and specificity for diagnosis of ≥ CIN2 lesions at colposcopy. Association between cytology and histology may have contributed to the findings.

Risk factors predicting pathological degradation after cervical excision in cervical intraepithelial neoplasia grade II P16-positive patients over 25 years old: a cross-sectional study.

Cervical intraepithelial neoplasia (CIN) is a collective term for pre-cancerous lesions associated with cervical invasive carcinoma. Treatment options depend on the development and progression of the disease. Especially for patients with CINII grade who are aged 25 years and older and have fertility requirements, it is a clinical challenge to determine whether to proceed with conservative or excisional treatment. Excisional treatment increases the risk of overtreatment outcomes, such as cervical insufficiency, preterm labor, miscarriage, and premature rupture of membranes, in young women with childbearing potential. P16 immunohistochemical staining has greatly improved the consistency of CINII patient's diagnosis. The aim of this study was to analyze the risk factors predicting pathological degradation after cervical excision in cervical intraepithelial neoplasia grade II P16-positive patients over 25 years old, and to provide information to help optimize clinical treatments patients with CINII disease. Single-factor and logistic regression models were used to analyze the risk factors for pathological downgrading in the CINII/P16-positive (+) group. The predicted probability of pathological downgrading in the CINII/P16(+) group of patients was calculated according to the logistic regression model to generate a new variable multi-indicator association for receiver operating characteristic (ROC) curve plotting to determine the predictive ability. A total of 248 women who met the inclusion and exclusion criteria were included. Statistical analysis showed that the CINII/P16(+) group had a higher pathological downgrading rate compared with the CINIII group after cold knife conization (CKC) (χ2=6.26, P=0.012). Univariate factors showed that the differences were statistically significant when comparing age, number of biopsy-involved quadrants, menopausal status, and involvement of glands, respectively (P<0.05). In contrast, the differences were not statistically significant when comparing cytological findings, type of transformation zone, high-risk human papilloma virus (HR-HPV) testing, abortion status, pregnancy frequency, time from diagnosis to CKC and Ki67 percentage between the two groups. Multifactorial logistic regression showed that the extent of biopsy CINII involvement [odds ratio (OR), 1.589], menopausal status (OR, 4.031), and glandular involvement (OR, 5.549) were all independent risk factors for pathological downgrading in the CINII/P16(+) patient group (P<0.05). The order of significance of the areas under the ROC curve (AUCs) was as follows: combined multiple indicators (AUC 0.716) > gland involvement (AUC 0.625) > biopsy CINII involvement extent (AUC 0.614) > menopausal status (AUC 0.565). A higher rate of pathological downgrading after CKC was found in CINII/P16-positive patients who were aged over 25 years. Overtreatment exists in patients with CINII/P16-positive diagnosis. Independent factors for pathological downgrading were identified by the factors including if the lesion involved the gland, the extent of CINII involvement on biopsy, and menopausal status.

Transformation zone types: a call for review of the IFCPC terminology to embrace practice in low-resource settings.

Most cervical cancers develop in the transformation zone (TZ). Type 3 TZs, where the full circumference of the squamocolumnar junction (SCJ) is not visible pose problems during cervical screening with visual inspection methods, as (pre)cancerous lesions may be missed. Several practical strategies can be implemented to convert type 3 TZs into TZ 1 or TZ 2, including the use of an endocervical speculum or hygroscopic cervical dilators, opening the vaginal speculum more widely, skillful use of cotton-tipped applicators, performing colposcopy in midcycle, and use of oral or vaginal misoprostol and estrogen to 'ripen' the cervix. With the 2011 International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology, settings with better resources to manipulate the cervix for a better view of the endocervical canal may assign patients to different categories from those in low-resource settings during a colposcopic examination. Here, we propose a colposcopic revision to the current IFCPC classification by segregating TZ 2 according to the extent of endocervical involvement and TZ 3 according to whether any attempt is made to open the endocervical canal, if such attempt(s) were successful, and the extent to which the practitioner can visualise parts of the uterine cervix beyond the border of the SCJ in the endocervical canal. In this proposed reclassification, TZ 2A has no part of the SCJ extending beyond 5 mm into the endocervical canal, whereas TZ 2B has part or all of the SCJ extending beyond 5 mm into the endocervical canal. TZ 3 is further subclassified into TZ 3A if the practitioner does not attempt to open the endocervical canal or the endocervical canal is opened, but not beyond 5 mm and TZ 3B if the full circumference cannot be visualised after opening the endocervical canal beyond 5 mm. We believe this revision will improve and better standardise the classification of TZ types, with huge implications for practice in low-resource settings, due to limited options for referral and treatment, to reduce the risk of missed cervical cancers and suboptimal treatment resulting from ablating lesions that extend too far into the endocervical canal.

Extensive lesions and a positive cone margin are strong predictors of residual disease in subsequent hysterectomy following conization for squamous intraepithelial lesion grade 2 or 3 study design

BackgroundThis study aimed to determine the predictive factors for post-conization of residual disease in subsequent hysterectomy for cervical intraepithelial neoplasia grade 2 or 3.MethodsThis retrospective study included 267 patients with histologically confirmed cervical intraepithelial neoplasia grade 2 or 3 who underwent hysterectomy within 7 months after conization. Clinical data (e.g., age, menopausal status, gravidity, parity, type of transformation zone, conization method) as well as pathological data pertaining to conization and hysterectomy were collected from medical records. A logistic regression model was used to analyze the relationship between the variables and risk of residual lesions in hysterectomy samples.ResultsOverall, 70 (26.2%) patients had residual lesions in their hysterectomy specimens. Univariate analyses revealed that age ≥ 50 years (p=0.019), endocervical gland involvement(p=0.013), positive margin(p < 0.001), and involvement of 3–4 quadrants(p < 0.001) were risk factors for residual lesions. Conversely, postmenopausal status, gravidity ≥ 3, parity ≥ 2, loop electrosurgical excision procedure, and type III transformation zone were not risk factors for residual lesions. A positive margin(p < 0.001) and multiple-quadrant involvement(p < 0.001) were identified as independent risk factors for residual lesions on multivariate analysis.ConclusionsMultiple-quadrant involvement and a positive cone margin were reliable predictive factors for residual disease. Total hysterectomy or repeated cervical conization should be considered for patients with these two risk factors. The identification of high-risk patients with extensive lesions by colposcopic examination before conization is indispensable, as it will enable surgeons to perform conization with consideration of risk factors and possibly improve the approach used for the excisional procedure. For high-risk patients, colposcope-guided cold-knife conization is preferred when resources permit.

Rate of Involved Endocervical Margins According to High-Risk Human Papillomavirus Subtype and Transformation Zone Type in Specimens with Cone Length ≤ 10 mm versus > 10 mm-A Retrospective Analysis.

The aim of this study was to evaluate the endocervical margin status according to transformation zone (TZ) and high-risk HPV (hr-HPV) subtype in specimens with cone length ≤ 10 mm versus > 10 mm to provide data for informed decision making and patients counseling especially for women wishing to conceive. In this retrospective cohort study, 854 patients who underwent large loop excision of the transformation zone during a nine-year period (2013-2021) for cervical disease were analyzed. The main outcome parameters were excision length, histological result, TZ type, HPV subtype and endocervical margin status. A subgroup analysis was performed according to excision length, with a cut-off value of 10 mm. A two-step surgical procedure was performed in case of an excision length of > 10 mm. The overall rate of positive endocervical margins irrespective of excision length was 17.2%, with 19.3% in specimens with ≤ 10 mm and 15.0% with > 10 mm excision length. Overall, 41.2% of women with a visible TZ and HPV 16/hr infection and 27.0% of women with HPV 18 received an excisional treatment of > 10 mm length without further oncological benefit, respectively. In contrast, assuming that only an excision of ≤ 10 mm length had been performed in women with visible TZ, the rate of clear endocervical margins would have been 63.7% for HPV 16/hr infections and 49.3% for HPV 18 infections. In conclusion, the decision about excision length should be discussed with the patient in terms of oncological safety and the risk of adverse pregnancy events. An excision length > 10 mm increases the number of cases with cervical tissue removed without further oncological benefit, which needs to be taken into account in order to provide an individual therapeutic approach. Furthermore, HPV 18 positivity is related to a higher rate of positive endocervical margins irrespective of TZ.

Positive margins in cervical H-SIL conization: Can we predict them?

Background: Cervical cancer is the second most common gynecological cancer in the female population. Cervical cancer screening includes cytology and tests for oncogenic subtypes of human papillomavirus (HPV), impacting on a significant decrease in mortality. In patients with a diagnosis of high-grade squamous intraepithelial lesion (HG SIL), the recommended management is excisional treatment (ET). The higher rate of persistent disease is associated with a positive margin status, larger lesion size, endocervical involvement and HPV positive test six months after treatment, especially HPV 16 subtype. Objective: To identify clinical and/or pathological features capable of predicting the compromise of the margins in the excisional treatment specimens. Methods: It is an observational, retrospective study carried out in Sanatorio Güemes between September 2017 and June 2020. All those patients with HG SIL who underwent excisional treatment were analyzed. The variables considered were the pre-treatment status of the endocervical canal, the size of the specimen (height), the type of transformation zone, the presence of greater pathology in the definitive specimen, the delay in consultation and the smoking habit. The relative risk of presenting compromised margins for each of the variables was analyzed. Findings: Our study shows 124 patients who received excisional treatment for HG SIL, 32 had compromised endocervical margins of the resection specimen. The delay in consultation between the biopsy and the ET has a significant impact on the state of the margins (RR 2,26; IC95 1,27-4; p 0,009). The presence of greater pathology (microinvasive carcinoma or higher stage) in the group with compromised margins (34,4% vs. 5,4%) highlights the importance of a comprehensive pre-treatment advisement to the patient concerning the diagnostic role of the ET in our population.

Developing a predictive nomogram for colposcopists: a retrospective, multicenter study of cervical precancer identification in China

BackgroundColposcopic examination with biopsy is the standard procedure for referrals with abnormal cervical cancer screening results; however, the decision to biopsy is controvertible. Having a predictive model may help to improve high-grade squamous intraepithelial lesion or worse (HSIL+) predictions which could reduce unnecessary testing and protecting women from unnecessary harm.MethodsThis retrospective multicenter study involved 5,854 patients identified through colposcopy databases. Cases were randomly assigned to a training set for development or to an internal validation set for performance assessment and comparability testing. Least Absolute Shrinkage and Selection Operator (LASSO) regression was used to reduce the number of candidate predictors and select statistically significant factors. Multivariable logistic regression was then used to establish a predictive model which generates risk scores for developing HSIL+. The predictive model is presented as a nomogram and was assessed for discriminability, and with calibration and decision curves. The model was externally validated with 472 consecutive patients and compared to 422 other patients from two additional hospitals.ResultsThe final predictive model included age, cytology results, human papillomavirus status, transformation zone types, colposcopic impressions, and size of lesion area. The model had good overall discrimination when predicting HSIL + risk, which was internally validated (Area Under the Curve [AUC] of 0.92 (95%CI 0.90–0.94)). External validation found an AUC of 0.91 (95%CI 0.88–0.94) across the consecutive sample, and 0.88 (95%CI 0.84–0.93) across the comparative sample. Calibration suggested good coherence between predicted and observed probabilities. Decision curve analysis also suggested this model would be clinically useful.ConclusionWe developed and validated a nomogram which incorporates multiple clinically relevant variables to better identify HSIL + cases during colposcopic examination. This model may help clinicians determining next steps and in particular, around the need to refer patients for colposcopy-guided biopsies.

CIN2 + detection in high-risk HPV patients with no or minor cervical cytologic abnormalities: a clinical approach validated by machine learning

PurposeTo evaluate the feasibility and diagnostic value of the combination of colposcopy, cytology and hrHPV (high-risk human papilloma virus) PCR (polymerase chain reaction) testing in patients with no or minor cytologic abnormalities and HPV high risk infection and to find the best predictors for the presence of CIN2 + in this patient collective.MethodsThree hundred and thirty-four hrHPV patients with normal cytology or minor cytologic abnormalities who had a colposcopic examination at the center of colposcopy at the university hospital Aachen in 2021 were enrolled in this retrospective cohort analysis. Multivariate logistic regression and a machine-learning technique (random forests, leave-one-out analysis) were used.ResultsThe overall risk for CIN2 + in hrHPV-positive patients with normal cytology was 7.7% (N = 18) (5% for CIN3 +), 18% (N = 16) (10.1% for CIN3 +) in patients with PAP IIp (ASC-US) and 62.5% (N = 5) (25% for CIN3 +) in patients with PAP IIg (AGC). Variables that show a statistically significant influence for the CIN-status are ‘major change’ as the result of colposcopy, transformation zone type T1, PAP IIg upon referral (AGC) and hrHPV category 1a (HPV 16/18) detection. Using machine learning (random forests) techniques, the main influencing variables were confirmed. A monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3 (in accordance to the IACR guidelines) was found.ConclusionIn the collective of hrHPV patients with no or minor cytologic abnormalities, the result of colposcopy and HPV PCR status are key predictors for the detection of CIN2 + with a monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3.

Inter- and intra-observer agreement in the assessment of the cervical transformation zone (TZ) by visual inspection with acetic acid (VIA) and its implications for a screen and treat approach: a reliability study

BackgroundIn low-resource countries, interpretation of the transformation zone (TZ) using the classification of the International Federation for Cervical Pathology and Colposcopy (IFCPC), adopted by the World Health Organization, is critical for determining if visual inspection with acetic acid (VIA) screening and thermal ablation treatment are possible. We aim to assess inter- and intra-observer agreement in TZ interpretation.MethodsWe performed a prospective multi-observer reliability study. One hundred cervical digital images of Human papillomavirus positive women (30–49 years) were consecutively selected from a Cameroonian cervical cancer screening trial. Images of the native cervix and after VIA were obtained. The images were evaluated for the TZ type at two time points (rounds one and two) by five VIA experts from four countries (Côte d’Ivoire, Cameroon, Peru, and Zambia) according to the IFCPC classification (TZ1 = ectocervical fully visible; TZ2 = endocervical fully visible; TZ3 = not fully visible). Intra- and inter-observer agreement were measured by Fleiss’ kappa.ResultsOverall, 37.0% of images were interpreted as TZ1, 36.4% as TZ2, and 26.6% as TZ3. Global inter-observer reliability indicated fair agreement in both rounds (kappa 0.313 and 0.288). The inter-observer agreement was moderate for TZ1 interpretation (0.460), slight for TZ2 (0.153), and fair for TZ3 (0.329). Intra-observer analysis showed fair agreement for two observers (0.356 and 0.345), moderate agreement for two other (0.562 and 0.549), and one with substantial agreement (0.728).ConclusionInterpretation of the TZ using the IFCPC classification, adopted by the World Health Organization, is critical for determining if VIA screening and thermal ablation treatment are possible. However, the low inter- and intra-observer agreement suggest that the reliability of the referred classification is limited in the context of VIA. It’s integration in treatment recommendations should be used with caution since TZ3 interpretation could lead to an important referral rate for further evaluation.Trial registration Cantonal Ethics Board of Geneva, Switzerland: N°2017–0110. Cameroonian National Ethics Committee for Human Health Research N°2018/07/1083/CE/CNERSH/SP.

Clinical predictors of residual disease in hysterectomy following a loop electrosurgical excision procedure for cervical intraepithelial neoplasia grade 3

ObjectiveTo investigate the predictors of residual disease in a hysterectomy following a loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN) 3.MethodsThis retrospective study identified 421 patients with histologically confirmed CIN 3 who underwent LEEP and subsequently had a hysterectomy within 6 months. The clinical data included age, parity, type of transformation zone, cytology results, human papillomavirus (HPV) genotype test, endocervical curettage (ECC), and pathological data of LEEP and hysterectomy were obtained from the medical records. A logistic regression model was used to analyze the relationship between the variables and the risk of residual disease in the hysterectomy samples.Results186 (44.18%) patients had residual disease in the hysterectomy specimens. The predictive markers of residual disease following LEEP included positive ECC, positive margin of the samples from LEEP, type II or III transformation zone, HPV16 and HPV18 infection, and other high-risk HPV. HPV-18 positivity (OR, 7.13; 95% CI, 3.49 to 14.56; p < 0.001) and type III transformation zone (OR, 6.37; 95% CI, 2.91 to 13.94; p < 0.001) were the most indicative of residual disease following LEEP.ConclusionPositive high-risk HPV, particularly HPV18, positive ECC, the positive margin of specimens from LEEP, and type II or III transformation zone were reliable prognostic markers of residual disease following a LEEP for CIN 3.

Screen-and-treat approach in managing cervical cancer precursor lesions: An observational study with 524 women

ObjectiveTo detect factors related to overtreatment with the “Screen-and-treat” approach (S&T) in women with suspicious cervical precancerous lesions. Study designA retrospective observational study of 524 women with high-grade squamous intraepithelial lesions (HSIL) or more severe (HSIL+) in cytology, treated by the Large Loop Excision of the Transformation Zone (LLETZ): 161 without a previous biopsy (S&T group) and 363 with a previous biopsy (biopsy group) from January 2017 to July 2020. The main outcome was a diagnosis of LLETZ: negative (negative or low-grade squamous intraepithlelial lesion LSIL) or HSIL+. A negative diagnosis was interpreted as “overtreatment.” Results were analyzed as a function of the S&T approach (whether previous biopsy or not). Variables were obtained from medical records, and were compared with Chi-square or Fisher's exact test (p, p-value), to estimate the chances of a logistic regression analysis (Odds Ratio, OR, or admitting a Confidence Interval (CI) of 95 %). ResultsNo differences were observed in groups regarding menopausal status, smoking, hormonal contraceptive use, colposcopy findings, LLETZ diagnosis, and recurrence. Comparing biopsy vs S&T groups, the frequency of women over 40 years was 28.4 % vs 39.7 % (p = 0.011), and transformation zone type 3 was 12.2 vs 26.8 % (p < 0.001), respectively. In women managed by S&T, when compared to a LLETZ diagnosis, an HSIL+ result was more frequent in women presenting with TZ 1 (93.1 % TZ1 vs 78.5 % TZ2 vs 73.8 % TZ3, p = 0.008) and in women with abnormal colposcopy (92.9 % abnormal vs 38.1 % negative, p < 0.001). Multiple regression analysis found that women with negative colposcopic findings presented a higher risk for negative LLETZ diagnosis (LSIL/Negative final histology) (18.6; 6.18–56.02). ConclusionsNo difference was observed in the LLETZ diagnosis in women who did or did not use the S&T approach: it was adequate for women referred by cytological HSIL along with high-grade colposcopic findings.

Concordance Rate of Colposcopy in Detecting Cervical Intraepithelial Lesions.

Background: The purpose of this research is to estimate the rate of concordance, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of colposcopy for high-grade squamous lesions and carcinomas (HSIL+). Methods: We conducted a retrospective study of colposcopies performed in the certified Dysplasia Unit in Erlangen between January 2015 and May 2022 (7.5 years). The colposcopic findings were correlated with biopsies obtained during examinations or surgery. Cases without histology were excluded. The primary outcome was the rate of concordance between the colposcopic and histological findings in relation to the type of transformation zone (TZ), examiner’s level of experience and age of the patients. Results: A total of 4778 colposcopies in 4001 women were analyzed. The rates of concordance for CIN I/LSIL, CIN II/HSIL, CIN III/HSIL, and carcinoma were 43.4%, 59.5%, 78.5%, and 53.9%, respectively. The rate of concordance was lowest for TZ3 and highest for colposcopists with more than 10 years’ experience. Conclusions: Colposcopy is an important, feasible, and effective method. Careful work-up needs to be performed for women with TZ3 who are over 35 years old, as they are at the highest risk of being misdiagnosed. The highest concordance for detecting HSIL+ was seen for colposcopists with >10 years’ experience.

Endocervical Margins Status in Excision for Preventing Cervical Cancer According to the Transformation Zone Type.

The aim of this study is to assess the outcomes of 610 excision types I and II in a referral facility as a function of transformation zone (TZ) types. This is a retrospective cohort study of women with cervical precursor lesions who underwent loop electrocautery excision procedure from 2017 to 2019 at the University of Campinas. The primary outcome was endocervical margin status, negative or positive. Other variables were excision type (I/II), TZ (1/2/3), age, menopausal status, hormonal contraceptives, smoking, and sexual debut. Tests used were chi-square or Fisher exact, Mann-Whitney, and simple and multiple logistic regression. The most frequent was TZ 1 (62.5%). Excision II was the most frequent: 54.1% in TZ 1, 67.2% in TZ 2, and 82.1% in TZ 3. A negative margin was observed in TZ 1, 76.0% when excision I and 86.4% when excision II ( p = .009); TZ 2, 86.4% when excision I and 88.9% when excision II ( p = .672); and TZ 3, 76.5% when excision I and 78.9% when excision II ( p = .672). Multivariate analysis revealed in TZ 1 a 2.12 (1.23-3.65) higher risk of obtaining a negative margin in excision type II. In TZ 2 and 3, none of the variables predicted the chance of a negative margin. The endocervical margin was negative in 3 in every 4 women who underwent loop electrocautery excision procedure, regardless of excision type. Age, menopausal status, smoking, and hormonal contraception did not predict margin status.

Stratified research on related risk factors of CINⅡ+ in CINⅠ patients diagnosed by endocervical curettage under colposcopy

Objective: To estimate risks of cervical intraepithelial neoplasia (CIN) Ⅱ or worse (CINⅡ+) on loop electrosurgical excisional procedure (LEEP) specimens with the diagnosis of endocervical curettage (ECC) CINⅠ compared with biopsy CINⅠ, and also to investigate the hierarchical management scheme of ECC CINⅠ based on the relevant factors of CINⅡ+ risk. Methods: (1) A retrospective computer-based research for subjects enrolled in the Obstetrics and Gynecology Hospital, Fudan University from Jan. 2013 to Jun. 2021 was performed. The case group comprised women with an ECC CINⅠ (ECC results of CINⅠ with colposcopy-directed biopsy results ≤CINⅠ), and the control group comprised women with a biopsy CINⅠ (colposcopy-directed biopsy results of CINⅠ with negative ECC findings) were divided after LEEP surgery and diagnosis in the next three months. The clinical data of all patients before LEEP were analyzed, and the pathological diagnosis between two groups after LEEP was compared. (2) Variables, including age, cytology, high-risk human papillomavirus (HR-HPV), ECC results, cervical transformation zone (TZ) and colposcopy impression, were included to describe the characteristics and compare the incidence of LEEP CINⅡ+. (3) Univariate analysis and Multivariate logistic regression method were used to analyze the related factors that affect the LEEP CINⅡ+ in CINⅠ patients. Further, the specific risks caused by related factors and conduct a stratified study in LEEP CINⅡ+ were analyzed. Results: (1) Overall, 2 581 women with ECC CINⅠ or biopsy CINⅠ diagnosis who underwent LEEP participated in the study with the mean age (43.6±9.5) years old. Chi square test found that the age and cytology of patients in ECC CINⅠ group were statistically different from those of biopsy CINⅠ group (all P<0.05). There was no significant difference in HR-HPV detection, TZ type and colposcopy impression between the two groups (all P>0.05). ECC CINⅠ comprised 957 women, with LEEP histopathology results revealing 288 (30.1%, 288/957) CINⅡ+, which was significantly higher than that of biopsy CINⅠ which was comprised 1 624 women, with LEEP histopathology results showing 333 (20.5%, 333/1 624) CINⅡ+ (χ2=30.31, P<0.001). (2) Compared by LEEP CINⅡ+ with LEEP ≤CINⅠ group, there were no significant difference in the age, HR-HPV, colposcopy impression (all P>0.05); but there were significantly differences in cytology, ECC CINⅠ, type Ⅲ TZ (all P<0.001). Multivariate logistic regression analysis showed that atypical squamous epithelial cells (ASC-H; OR=2.77, 95%CI: 2.04-3.77), high-grade squamous intraepithelial lesions and worse (HSIL+; OR=2.93, 95%CI: 2.24-3.81), ECC CINⅠ (OR=1.89, 95%CI: 1.56-2.29) and type Ⅲ of TZ (OR=1.76, 95%CI: 1.45-2.11) were independent risk factors for LEEP CINⅡ+ (all P<0.05). (3) When cytology was ≤low-grade squamous intraepithelial lesion (LSIL) and ≥ASC-H, the detection rate of CINⅡ+ in ECC CINⅠ was significantly higher than that of biopsy CINⅠ (all P<0.001). In ECC CINⅠ, the rate of CINⅡ+ with cytology ≤LSIL was significantly lower than that in cytology ≥ASC-H (56.0% vs 25.9%; χ2=49.38, P<0.001). In type Ⅰ/Ⅱ of TZ, the detection rate of CINⅡ+ between ECC CINⅠand biopsy CINⅠ had no significantly different; while in type Ⅲ of TZ, there was significantly different (72.7% vs 46.2%; χ2=4.02, P=0.045). In ECC CINⅠ, type Ⅲof TZ was significantly higher in the rate of CINⅡ+ than that of type Ⅰ/Ⅱ of TZ (72.7% vs 21.7%; χ2=16.38, P<0.001). When cytology ≥ASC-H, type Ⅲ of TZ and colposcopy impression of HSIL were combined, the rate of CINⅡ+ in ECC CINⅠ was 6/6 while 1/3 in biopsy CINⅠ. Conclusions: Cytology ≥ASC-H, ECC CINⅠ and type Ⅲ TZ are the risk factors of LEEP CINⅡ+. However, cytology ≥ASC-H is more valuable in predicting LEEP CINⅡ+ than ECC CINⅠ. For patients with ECC CINⅠ to perform LEEP, it is recommended that cytology ≥ASC-H is taken as the first level stratification, and type Ⅲ TZ is taken as the second level stratification. The colposcopy impression of patients is recommended for a reference parameter.

Efficacy of photodynamic therapy with 5-aminolevulinic acid for the treatment of cervical high-grade squamous intraepithelial lesions with high-risk HPV infection: A retrospective study

BackgroundThe current principle of clinical management of cervical high-grade squamous intraepithelial lesion(HSIL) is surgical excision. However excisional procedures of the uterine cervix may have a negative impact on fertility. Topical photodynamic therapy(PDT) is a non-invasive and selective tissue destruction. We investigated the clinical efficacy of PDT for cervical HSIL with high-risk human papilloma virus(HPV) infection. MethodsA retrospective study consisting of 96 patients aged 20–50 years with a histologically confirmed cervical HSIL with high-risk HPV infection from July 2018 to June 2022 was carried out. Patients were treated with six times of 20% 5-aminolevulinic acid photodynamic therapy (5-ALA PDT) at intervals of 7–14 days. Three months after treatment, the effect was evaluated through HPV typing and colposcopy directed biopsy. Six and twelve months after treatment, TCT and HPV tests were carried out. ResultsThree months after 5-ALA PDT treatment, among 96 HSIL with high-risk HPV infection patients, the total lesion regression rate was 89.58%(86/96), and the HPV clearance rate was 79.17 % (76/96) at 3 months follow-up. At 6 and 12 months follow-up, the patients who was HSIL pathological regression and negative HPV at 3 months follow-up continued negative results in both TCT and HPV. All patients with ineffective 5-ALA PDT treatment had persistent HPV infections. There was no significant difference in the HSIL regression rate and HPV clearance rate among different age groups. The main side effects of PDT were abdominal pain and increased vaginal secretions. Univariate analysis showed that the different severity of cervical cytology was associated with lesion regression rate in 5-ALA PDT treatment. The HSIL regression rate of TCT<ASC-H was higher than that of TCT≧ASC-H(94.59% vs 72.72%; P<0.01).Multicentric lesions,the proportion of visible lesion size in ectocervical size≥24.59%, size of visible lesion ≥1.23cm2 and maximum linear length of visible lesion ≥0.90cm were risk factors of HSIL persistence after 5-ALA PDT treatment (P<0.05). Conclusion5-ALA PDT can be a safe and efficient treatment for cervical HSIL who wish to preserve fertility. 5-ALA PDT did not appear to create cervical damage and have negligible side effects. But we need evaluate the type of transformation zone, the visible lesion size, the location of lesion,baseline status of TCT and histological results before 5-ALA PDT treatment.