Clinical application of the 2011 IFCPC colposcope terminology.

BACKGROUND: Colposcopy offers an accurate way to the diagnose of cervical precancerous lesions. However, the diagnostic accuracy of colposcopy is unsatisfied. This study was to evaluate colposcopic accuracy according to the 2011 International Federation of Cervical Pathology and Colposcopy (IFCPC) terminology. METHODS: A retrospective cohort study was performed in 1,838 patients who underwent colposcopy in Shandong Qianfoshan Hospital, Cheeloo College of Medicine, Shandong University from October 2013 to April 2018. Using conization or cervical biopsy pathology as the gold standard, the agreement between colposcopic diagnosis and pathologic diagnosis was calculated, and correlations between variables were analyzed. RESULTS: As an authoritative and widely used terminology for colposcopy diagnosis, the 2011 IFCPC terminology has certain clinical practicality and diagnostic accuracy. However, some signs such as mosaic, punctation, sharp border, inner border sign and ridge sign had high specificity but unsatisfactory sensitivity, which limited the diagnostic value. Therefore, we discussed the Lugol's staining, a very common sign in colposcopy, and analyzed the diagnostic significance of bright yellow staining in low-grade squamous intraepithelial lesion (LSIL) and mustard yellow staining in high-grade squamous intraepithelial lesion (HSIL). The results showed that mustard yellow may be a valuable indicator in the diagnosis of HSIL. CONCLUSION: The 2011 IFCPC colposcope terminology has standardized interpretations of the colposcopic findings and improved the accuracy of colposcopy diagnosis. The aceto-white epithelium still has important diagnostic value; however, the value of a few signs is needed to be discussed and new signs are expected to be discovered. Although the significance of Lugol's staining was diminishing, mustard yellow might be a valuable indicator for the diagnosis of HSIL.

Portable Pocket colposcopy performs comparably to standard-of-care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru.

OBJECTIVE: Our goal was to develop a tele-colposcopy platform for primary-care clinics to improve screening sensitivity and access. Specifically, we developed a low-cost, portable Pocket colposcope and evaluated its performance in a tertiary healthcare centre in Peru. DESIGN AND SETTING: Images of the cervix were captured with a standard-of-care and Pocket colposcope at la Liga Contra el Cáncer in Lima, Peru. POPULATION: Two hundred Peruvian women with abnormal cytology and/or human papillomavirus positivity were enrolled. METHODS: Images were collected using acetic acid and Lugol's iodine as contrast agents. Biopsies were taken as per standard-of-care procedures. MAIN OUTCOME MEASURES: After passing quality review, images from 129 women were sent to four physicians who provided a diagnosis for each image. RESULTS: Physician interpretation of images from the two colposcopes agreed 83.1% of the time. The average sensitivity and specificity of physician interpretation compared with pathology was similar for the Pocket (sensitivity = 71.2%, specificity = 57.5%) and standard-of-care (sensitivity = 79.8%, specificity = 56.6%) colposcopes. When compared with a previous study where only acetic acid was applied to the cervix, results indicated that adding Lugol's iodine as a secondary contrast agent improved the percent agreement between colposcopes for all pathological categories by up to 8.9% and the sensitivity and specificity of physician interpretation compared with pathology by over 6.0 and 9.0%, respectively. CONCLUSIONS: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when used to identify precancerous and cancerous lesions using acetic acid and Lugol's iodine during colposcopy examinations in Peru. TWEETABLE ABSTRACT: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when identifying cervical lesions.

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

OBJECTIVE: Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope. MATERIALS AND METHODS: There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs. RESULTS: For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%). CONCLUSIONS: Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.

Evaluation of active camera control systems in gynecological surgery: construction, handling, comfort, surgeries and results.

OBJECTIVE: Surgeon-controlled endoscope leading assistance systems are a novelty in endoscopic surgery. These systems were evaluated for their applicability and reliability in operative gynecology. In this regard, we evaluated possible methods of operation, operative time, setup time, and comfort for the surgeon, complications, blood transfusions, length of stay, hemoglobin levels, and demographic data. METHODS: Two systems with technically identical camera control systems were applied, the SOLOASSISTTM system and the Einstein VisionTM 3D system. The arm systems are attached to the operating table and controlled by surgeon via a manual control, a remote control or a foot switch. Comfort for the surgeon was evaluated using a questionnaire (scale 1-5; 1 "very good", 5 "poor"). All data were collected prospectively in a database (IBM SPSS Statistics 20) and evaluated. RESULTS: One hundred and four patients underwent surgery supported by an active control system. In 43 (41 %) cases, oncological interventions were performed. Average setup time was 7 (3-30) min. There was a significant learning curve regarding the mounting of the system after 20 operations (p = 0.045). Overall comfort was rated as "good", divided into control 2.2 (2-4), physical effort 2.1 (1-4), picture quality 1.6 (1-3), and overall satisfaction 2.1 (1-4). About 75 unwanted camera movements were noticed in 104 surgeries. Complications occurred in no case (0 %). CONCLUSION: The application of an active camera control system was evaluated to be safe for all gynecological laparoscopies. Picture blur is avoided even during prolonged complex procedures. Moreover, the assistant is able to support the surgeon with two instruments, with the result that the presence of a second assistant is not required for complex interventions. Causing only minimal setup time, the examined active control systems improve the effectiveness of surgeries. The physical effort required for the assistant decreases and, by reducing tiring operations and tremor, subsequently, higher precision is reached.

Risk factors for treatment failure of CO2 laser vaporization in cervical intraepithelial neoplasia 2.

PURPOSE: The aim of our study was to evaluate the risk factors for treatment failure of CO2 laser vaporization in patients with cervical intraepithelial neoplasia 2 (CIN2). METHODS: Medical records of patients who received either shallow or deep CO2 laser vaporization with biopsy-proven CIN2 during March 2007 to April 2011 were reviewed retrospectively. After laser vaporization, liquid-based cytology and human papilloma virus (HPV) DNA testing were checked in every follow-up visit. Treatment failure was defined when the follow-up biopsy was more than CIN2, needing secondary surgical treatment. RESULTS: During that period, 141 patients with CIN2 underwent CO2 laser vaporization. After laser ablation, 14 of 141 women needed the secondary treatment, a success rate of laser vaporization of 90.1 %. In multivariate analysis, the previous loop electrosurgical excision procedure (LEEP) history (adjusted OR = 13.649; P value = 0.025) and the ablation depth (adjusted OR = 11.279; P value = 0.006) were independent factors associated with treatment failure. CONCLUSION: Both ablation depth and previous LEEP history were the important factors increasing the risk for the treatment failure of CO2 laser vaporization in CIN2.

Fluorescence colposcope with TMTP1-PEG4-ICG is comparable to the conventional colposcope in identifying cervical precancerous lesions: A randomized controlled trial.

OBJECTIVE: To compare the diagnostic efficiency of a fluorescence colposcope with TMTP1-PEG4-ICG dye versus a conventional colposcope with acetic acid and Lugol's iodine in identifying cervical precancerous lesions. METHODS: In all, 218 women with abnormal cervical cancer screening results including cytology and/or human papillomavirus (HPV) test were involved in the randomized controlled trial. Patients in the fluorescence colposcope group had TMTP1-PEG4-ICG dye applied to the cervix uteri before colposcopy. Patients in the conventional colposcope group were routinely administered acetic acid and Lugol's iodine to stain the cervix uteri. Two to four cervical sites per patient were taken out for biopsy. The diagnostic efficiency of fluorescence colposcopy and conventional colposcopy was calculated on a per-patient and per-site basis. χ2 test or Fisher exact test was used. RESULTS: A total of 194 patients and the corresponding 662 cervical sites were included in the final analysis. There was no statistically significant difference in the diagnostic efficiency between the two groups both on a per-patient and a per-site basis, including accuracy, sensitivity, specificity, positive predictive value, and negative predictive value. CONCLUSIONS: The fluorescence colposcope with TMTP1-PEG4-ICG dye was comparable to the conventional colposcope in identifying cervical precancerous lesions.

Agreement between colposcopic impression and histological diagnosis among human papillomavirus type 16-positive women: a clinical trial using dynamic spectral imaging colposcopy.

OBJECTIVE: To investigate the agreement between conventional colposcopic impression, dynamic spectral imaging (DSI) colposcopy and histology, for human papillomavirus type 16-positive (HPV16(+)) and non-16 high-risk (hr) HPV(+) women. DESIGN: Prospective, comparative, multicentre clinical trial. SETTING: Three colposcopy clinics in the Netherlands. POPULATION: Women (n = 177) aged 18 years or over with an intact cervix, referred for colposcopy. METHODS: The colposcopist graded the lesion by using the DSI colposcope as a regular video colposcope. Subsequently the DSI impression was displayed and biopsies were taken from all abnormal areas as well as from a random (normal) site. A cervical smear was taken for HPV typing. MAIN OUTCOME MEASURES: Histologically confirmed high-grade cervical intraepithelial neoplasia or cancer (CIN2(+)), positive for HPV16 or for any other hrHPV type. RESULTS: The DSI colposcope identified more CIN2(+) cervical lesions among HPV16(+) women than in non-16 hrHPV(+) women (P = 0.032 regardless of final histology and P = 0.009 among women with CIN2(+)). Consequently, the sensitivity of the DSI colposcope for detecting CIN2(+) lesions was higher in HPV16(+) women than in non-16 hrHPV(+) women (97% versus 74%, P = 0.009). No such differences were seen for the colposcopist impression. In addition, mainly smaller cervical lesions are missed by the colposcopist. CONCLUSIONS: The sensitivity of DSI colposcopy for CIN2(+) is higher in HPV16(+) than in non-16 hrHPV(+) women. Furthermore, regardless of HPV16 status, the sensitivity of DSI for CIN2(+) is higher than that of the colposcopist, probably because colposcopists tend to miss smaller cervical lesions.

Can portable Colposcopes Replace Standard-of-care Colposcopes? A Crossover Trial of Two Portable Colposcopes with a Standard-of-Care Video Colposcope.

BACKGROUND: Screen positive women need to be triaged by colposcopy which is a major challenge in low-middle income countries. Portable colposcopes may overcome many challenges, reduce referrals and enable a single visit approach. This study assessed the performance of portable colposcopes and potential to reduce referral. METHOD: This crossover randomised study enrolled women aged 25 to 65 years with abnormal screening result or cervical symptoms. All women underwent visual inspection with acetic acid (VIA), HPV test, colposcopy with two portable colposcopes (Gynocular®, Gynius, Sweden, and Pocket® transvaginal colposcope, Duke University, NC, USA) and a standard video colposcope, and biopsy. Colposcopic Swede score agreement between portable and video colposcopes, as well as agreement of Swede score with histology were calculated for each device. The potential impact of portable colposcopes in a single visit approach was assessed based on the final diagnosis. RESULTS: Among 250 subjects, 27(10.80%) had high-grade cervical intraepithelial neoplasia (CIN2+) lesions. Swede scores for Pocket and Gynocular colposcopes were similar to video colposcope in 248 (99.20%) and 247 (98.80%) subjects, respectively (agreement scores 0.9969 and 0.9954, respectively). At a Swede score cut-off of ≥5, all three devices had identical sensitivity, specificity, positive and negative predictive value of 96.30%, 92.30%, 60.50% and 99.50,. Ablative treatment offered at field setting would result in optimal treatment in 52.0% and 85.1% cases when screened with VIA and HPV test respectively; using Pocket colposcope could improve this to 94.0% and 95.9%, respectively. Overtreatment and referral rates reduced from 46.8% and 12.4% to 4.8% and 6.0%, respectively, when VIA test is followed by triage with pocket colposcope. These outcomes were comparable to screening with HPV followed by colposcopy triage. CONCLUSIONS: Pocket colposcope performed comparably to the video colposcope. Used by healthcare providers in the field setting, they can augment the results of VIA significantly.

Absence of lower genital tract lesions among women of reproductive age infected with Schistosoma mansoni: A cross-sectional study using a colposcope in Western Kenya.

BACKGROUND: Female genital schistosomiasis (FGS) constitutes four different lesions known to be caused by Schistosoma haematobium ova deposited in the genital tract. Schistosoma mansoni ova may also be found in the genital tract. However, it is not known if S. mansoni causes lower genital tract lesions characteristic of FGS. METHODOLOGY: This study was conducted in 8 villages along the shores of Lake Victoria, western Kenya. Stool and urine samples, collected from women of reproductive age on three consecutive days, were analysed for S. mansoni and S. haematobium infection. S. mansoni positive and S. haematobium negative willing participants, aged 18-50 years were invited to answer a questionnaire (demographics, symptoms), undergo a gynaecological examination and cytology specimen collection by an FGS expert. PRINCIPAL FINDINGS: Gynaecologic investigations were conducted in 147 S. mansoni-positive women who had a mean infection intensity of 253.3 epg (95% CI: 194.8-311.9 epg). Nearly 90% of them used Lake Victoria as their main water source. None were found to have cervicovaginal grainy sandy patches or rubbery papules. Homogenous yellow patches were found in 12/147 (8.2%) women. Women with homogenous yellow patches were significantly older (47 years) than the rest (34 years, p = 0.001). No association was found between intensity of S. mansoni infection and homogenous yellow patches (p = 0.70) or abnormal blood vessels (p = 0.14). S. mansoni infection intensity was not associated with genital itch, bloody or malodorous vaginal discharge. CONCLUSION: S. mansoni infection was neither associated with lower genital tract lesions nor symptoms typically found in women with FGS.

Endocervical microglandular hyperplasia: Colposcopic aspects, physiopathology and differential diagnosis.

Endocervical microglandular hyperplasia (MGH) is a reactive type of glandular lesion that may be confused with endocervical adenocarcinoma from the macroscopic and the colposcopic findings, as well as from a histological. Differential diagnosis is very important. Here, we report a case of a 21 years-old women with a challenging differential diagnosis in the colposcopy and a MGH as histological finding.

Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging.

Global anal cancer incidence is increasing. High resolution anoscopy (HRA) currently screens for anal cancer, although the definitive test remains unknown. To improve on intraluminal imaging of the anal canal, we conducted a first-in-human study to determine feasibility and safety of a high-resolution, wide field-of-view scanning endoscope. Fourteen patients, under an IRB-approved clinical study, underwent exam under anesthesia, HRA, and imaging with the experimental device. HRA findings were photographed using an in-line camera attached to the colposcope and compared with the scanning endoscope images. Patients were followed up within 2 weeks of the procedure. The imaging device is inserted into the anal canal and the intraluminal surface is digitally photographed in 10 s and uploaded to a computer monitor for review. Ten patients completed imaging with the device. Three patients were not imaged due to severe anal stenosis. One patient was not imaged due to technical device malfunction. The device images were compared to the HRA images. No adverse event attributable to the device was reported. The intraluminal scanning endoscope can be used for circumferential anal canal imaging and is safe for clinical use. Future clinical studies are needed to evaluate the performance of this device.

Robot-assisted laparoscopic colposacropexy and cervicosacropexy with the da Vinci® surgical system.

Colposacropexy is the gold standard operation for repair of apical vaginal support defects. Although it is feasible to perform this operation using conventional laparoscopic techniques, a limited number of surgeons have mastered the advanced minimally invasive skills that are required. Introduction of the da Vinci® robotic system (Intuitive Surgical, Sunnyvale, CA) with instruments that have improved dexterity and precision and a camera system with three-dimensional imaging presents an opportunity for more surgeons treating women with pelvic organ prolapse to perform the procedure laparoscopically. This chapter outlines a technique that is exactly modeled after the open procedure for completion of a robotic-assisted colpo- and cervicosacropexy using the da Vinci® surgical system.

Combining multiple contrasts for improving machine learning-based classification of cervical cancers with a low-cost point-of-care Pocket colposcope.

We apply feature-extraction and machine learning methods to multiple sources of contrast (acetic acid, Lugol's iodine and green light) from the white Pocket Colposcope, a low-cost point of care colposcope for cervical cancer screening. We combine features from the sources of contrast and analyze diagnostic improvements with addition of each contrast. We find that overall AUC increases with additional contrast agents compared to using only one source.

Design and implementation of a portable colposcope Mueller matrix polarimeter.

SIGNIFICANCE: Mueller matrix polarimetry can provide useful information about the function and structure of the extracellular matrix. A portable and low-cost system could facilitate the clinical assessment of cervical anomalies in low-resource settings. AIM: We introduce a low-cost snapshot Mueller matrix polarimeter that does not require external power, has no moving parts, and can acquire a full Mueller matrix in ∼1 s, to conduct a feasibility study for cervical imaging in the low-resource setting. APPROACH: A snapshot system based on two sets of Savart plates, a ring illuminator with polarizing elements (generating four polarization states), and one camera is introduced. Stokes vectors are formulated to recover the polarization properties of the sample. Then, using Mueller matrix decomposition, the depolarization and retardance information is extracted. RESULTS: We report the results on 16 healthy individuals (out of 22 patients imaged), whose Pap smear showed no malignant findings from mobile clinics in rural region of Mysore, India. The depolarization and retardance information was in agreement with previous reports. CONCLUSIONS: We introduce an imaging system and conducted a feasibility study on healthy individuals. This work could futurely translate into diagnostic applications to provide a quantitative platform in the clinical environment (e.g., cervical cancer screening).

Digital colposcopy: ready for use? An overview of literature.

The aims of this review were to summarise the various methods of digital colposcopy and to provide an overview of their efficacy. We conducted a literature search and focused on papers that described a technique for colposcopy, other than conventional colposcopy, and compared this with conventional colposcopy and/or histology and included digitalisation of the process. All papers have been classified in one of the following categories: digital imaging and telecolposcopy, spectroscopy, computerised colposcopy, optical coherence tomography and confocal microcolposcopy. Among the most promising developments is spectroscopy, allowing a more or less automated analysis and interpretation of the colposcopic image.

Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope.

GOAL: In this paper, we propose methods for (1) automatic feature extraction and classification for acetic acid and Lugol's iodine cervigrams and (2) methods for combining features/diagnosis of different contrasts in cervigrams for improved performance. METHODS: We developed algorithms to pre-process pathology-labeled cervigrams and extract simple but powerful color and textural-based features. The features were used to train a support vector machine model to classify cervigrams based on corresponding pathology for visual inspection with acetic acid, visual inspection with Lugol's iodine, and a combination of the two contrasts. RESULTS: The proposed framework achieved a sensitivity, specificity, and accuracy of 81.3%, 78.6%, and 80.0%, respectively, when used to distinguish cervical intraepithelial neoplasia (CIN+) relative to normal and benign tissues. This is superior to the average values achieved by three expert physicians on the same data set for discriminating normal/benign cases from CIN+ (77% sensitivity, 51% specificity, and 63% accuracy). CONCLUSION: The results suggest that utilizing simple color- and textural-based features from visual inspection with acetic acid and visual inspection with Lugol's iodine images may provide unbiased automation of cervigrams. SIGNIFICANCE: This would enable automated, expert-level diagnosis of cervical pre-cancer at the point of care.

An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia.

The incidence of anal squamous cell carcinoma (ASCC) in the U.S. is increasing, particularly in immunocompromised patients. Preventative screening is used to monitor precancerous dysplasia known as anal intraepithelial neoplasia (AIN), which can progress to ASCC. High Resolution Anoscopy (HRA) is one screening procedure that uses a colposcope with acetic acid and Lugol's iodine solution to visualize the anal epithelium for AIN. HRA has offered potential in managing AIN, but as more evidence emerges it is unclear whether HRA provides definitive benefit. This narrative review updates readers on the efficacy of HRA in screening AIN, compares HRA to other techniques, compares the use of HRA in various high-risk populations, and offers practical information on the use of HRA. Keyword searches were conducted using MEDLINE, Web of Science, and Cochrane Library. Current literature is mixed regarding the utility of HRA. Further randomized controlled trials are needed to definitively assess the role of HRA.

Optical imaging of cervical precancerous lesions based on active stereo vision and motion tracking.

A 3-D optical imaging system based on active stereo vision and motion tracking is built to track the motion of patient and to register the time-sequenced images of cervix recorded during colposcopy. The imaging system is evaluated by examining human subjects in vivo before routine colposcopy examination procedures. The system tracks the motion of patient accurately. The temporal kinetics of the acetowhitening process in the area of interest can be quantitatively measured. The results demonstrate that the kinetics of acetowhitening may be potentially used for accurately differentiating the precancerous lesions from the normal and benign lesions, and grading the precancerous lesions.