Large retrorectal spindle cell sarcoma: A case report and brief review of the literature.

Large retrorectal tumors are rare and often a diagnostic and surgical challenge due to their anatomical location. We report the case of a 55-year-old patient with weight loss and changed bowel habits, where digital rectal examination revealed a retrorectal mass raising suspicion of a tumor. Magnetic resonance imaging (MRI) and computed tomography (CT) showed a large retrorectal tumor and histopathology after surgical resection showed undifferentiated spindle cell sarcoma. This tumor type has not been previously reported as the etiology of large retrorectal tumors. We discuss the implications of diagnostic imaging, especially MRI, in the approach to diagnosis and surgical treatment of retrorectal tumors with reference to the scientific literature and previously reported cases of retrorectal tumors.

ctDNA-guided adjuvant treatment after radical-intent treatment of metastatic spread from colorectal cancer-the first interim results from the OPTIMISE study.

BACKGROUND: Patients with detectable ctDNA after radical-intent treatment of metastatic spread from colorectal cancer (mCRC) have a very high risk of recurrence, which may be prevented with intensified adjuvant chemotherapy (aCTh). In the OPTIMISE study, we investigate ctDNA-guided aCTh after radical-intent treatment of mCRC. Here we present results from the preplanned interim analysis. MATERIAL AND METHODS: The study is an open-label 1:1 randomized clinical trial comparing ctDNA-guided aCTh against standard of care (SOC), with a run-in phase investigating feasibility measures. Key inclusion criteria; radical-intent treatment for mCRC and clinically eligible for triple-agent chemotherapy. Patients underwent a PET-CT scan before randomization. ctDNA analyses of plasma samples were done by ddPCR, detecting CRC-specific mutations and methylation of the NPY gene. In the ctDNA-guided arm, ctDNA positivity led to an escalation strategy with triple-agent chemotherapy, and conversely ctDNA negativity led to a de-escalation strategy by shared-decision making. Patients randomized to the standard arm were treated according to SOC. Feasibility measures for the run-in phase were; the inclusion of 30 patients over 12 months in two Danish hospitals, compliance with randomization >80%, rate of PET-CT-positive findings <20%, and eligibility for triple-agent chemotherapy >80%. RESULTS: Thirty-two patients were included. The rate of PET-CT-positive cases was 22% (n = 7/32). Ninety-seven percent of the patients were randomized. Fourteen patients were randomly assigned to SOC and sixteen to ctDNA-guided adjuvant treatment and follow-up. All analyses of baseline plasma samples in the ctDNA-guided arm passed the quality control, and 19% were ctDNA positive. The median time to result was three working days. All ctDNA-positive patients were eligible for triple-agent chemotherapy. CONCLUSION: The study was proven to be feasible and continues in the planned large-scale phase II trial. Results from the OPTIMISE study will potentially optimize the adjuvant treatment of patients undergoing radical-intent treatment of mCRC, thereby improving survival and reducing chemotherapy-related toxicity.

Delta tocotrienol as a supplement to FOLFOXIRI in first-line treatment of metastatic colorectal cancer. A randomized, double-blind, placebo-controlled phase II study.

PURPOSE: Triplet chemotherapy might be more effective than doublet chemotherapy in metastatic colorectal cancer (mCRC), but it may also be marked by increased toxicity. To investigate whether δ-tocotrienol, a vitamin E analogue, with possible neuroprotective and anti-inflammatory effects, reduces the toxicity of triplet chemotherapy, we conducted a randomized, double-blind, placebo-controlled trial in mCRC patients receiving first-line 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI). MATERIAL AND METHODS: Seventy patients with mCRC were randomly assigned (1:1) to receive FOLFOXIRI plus either δ-tocotrienol or placebo at the Department of Oncology, Vejle Hospital, Denmark. Eligibility criteria were adenocarcinoma in the colon or rectum, age 18-75 years and ECOG performance status 0-1. FOLFOXIRI was given in eight cycles followed by four cycles of 5-fluorouracil. δ-tocotrienol 300 mg or placebo × 3 daily was added during chemotherapy and for a maximum of two years. The primary endpoint was time to hospitalization or death during treatment with chemotherapy. RESULTS: Median time to first hospitalization or death was 3.7 months in the placebo group (95% CI 1.93-not reached (NR)), and was NR in the δ-tocotrienol group (95% CI 1.87-NR) with a hazard ratio of 0.70 (95% CI 0.36-1.36). Grade 3-4 toxicities were uncommon in both groups, except for neutropenia, which occurred in 19 patients (58%) in the placebo group and 17 patients (50%) in the δ-tocotrienol group. There were no grade 3 or 4 peripheral sensory neuropathy. In the placebo group, 24 patients (71%) had oxaliplatin dose reductions compared to 17 patients (47%) in the δ-tocotrienol group (p = 0.047). CONCLUSION: The addition of δ-tocotrienol to FOLFOXIRI did not statistically significant prolong the time to first hospitalization or death compared to FOLFOXIRI plus placebo. Toxicity was manageable and not statistically different. There was a statistically significant difference in dose reductions of oxaliplatin pointing to a possible neuroprotective effect of δ-tocotrienol.

Intestinal ultrasound in patients with suspected Crohn's disease - results of a prospective evaluation by trainees.

BACKGROUND AND AIMS: Intestinal ultrasound (IUS) performed by experts is a valuable tool for the diagnostic work-up and monitoring of Crohn's disease (CD). However, concern about insufficient training and perceived high inter-observer variability limit the adoption of IUS in CD. We examined the diagnostic accuracy of trainee-performed IUS in patients with suspected CD. METHOD: Patients recruited to a prospective trial investigating the diagnostic accuracy of magnetic resonance enterocolonography (MREC) in patients with clinically suspected CD underwent IUS performed by trainees. The primary end-point was IUS per-patient sensitivity and specificity for ileocolonic CD determined by ileocolonoscopy. RESULTS: 129 patients with clinically suspected CD and a complete IC and IUS were included in the analysis. IUS detected signs of CD in 49 cases (small bowel 31, colon 15, small bowel, and colon 3). The sensitivity and specificity for detection of ileocolonic CD by trainee performed IUS improved during the first to the second half of the study period from 57.1% (CI 34.0-78.2) to 73.1% (CI 52.2-88.4) and 76.5% (CI 58.8-89.3) to 89.7% (CI 72.6-97.8). The overall sensitivity and specificity of diagnosing CD with IUS were 65.4% (CI 50.9-78.0) and 80.5% (CI 69.9-88.7). There was no difference in diagnostic performance between IUS and MREC for the detection of CD. CONCLUSION: Trainees improved during the study, and IUS performance in disease detection corresponded to expert-evaluated MREC.Registered at ClinicalTrials.gov (NCT03134586).

Calcium electroporation in cutaneous metastases - A non-randomised phase II multicentre clinical trial.

BACKGROUND: Cutaneous metastases can cause distressing symptoms and be challenging to treat. Local therapies are essential in management. Calcium electroporation uses calcium and electrical pulses to selectively kill cancer cells. This multicentre study aimed to define response in cutaneous metastases across different cancer types. METHODS: Patients with tumours ≤3 cm of any histology were included (stable or progressing on current therapy ≥2 months), at three centres. Tumours were treated with 220 mM calcium chloride injection and manual application of eight 0.1 ms pulses with 1 kV/cm and 1Hz with a handheld electrode, in local or general anaesthesia. Clinical response was evaluated after 1, 2, 3, 4, 5, 6, and 12 months. Primary endpoint was response at two months. The overall response rate (ORR) was partial- and complete responses of treated tumours. MR-imaging and qualitative interviews were performed in respective subsets. RESULTS: Nineteen patients with disseminated cancer (breast n = 4, lung n = 5, pancreatic n = 1, colorectal n = 2, gastric n = 1, and endometrial cancer n = 1) were enrolled, and 58 metastases were treated (50 once, 8 retreated). The ORR was 36% (95% CI 22-53) after two months. Best ORR was 51% (CR 42%; PR 9%). Previous irradiation improved outcomes (p = 0.0004). Adverse events were minimal. Median pain score was reduced after two months (p = 0.017). Treatment may relieve symptoms according to qualitative interviews. MRI showed restriction in treated tissue. CONCLUSION: The majority of tumours were treated only once with calcium electroporation, achieving an ORR of 36% after two months and best ORR of 51%. Efficacy, symptom-relief and safety support calcium electroporation as a palliative treatment option for cutaneous metastases.

Using structured templates or free text style in reporting CT staging on colon cancer: a national survey.

BACKGROUND: Computed tomography (CT) is a widely used method for the staging of colon cancer. Accurate reports could lead to a better preoperative evaluation and planning of the treatment of colon cancer. PURPOSE: To evaluate the use of CT free-text reports and structured report templates when it comes to staging CT imaging of colon cancer. MATERIAL AND METHODS: A multiple choice questionnaire survey was conducted over four weeks. Online questionnaire software was used, and a link was shared to medical doctors with help from the Danish Colorectal Cancer Group (DCCG) and from a social media radiologist group. RESULTS: Clinicians preferred the template style (95%), whereas the level of support was lower among the radiologists (76%). All female responders preferred the template style, in contrast to only 84% of the male responders. Furthermore, the survey showed a slightly deficient level of the national CT reporting quality; only 7/13 questions and sub-questions, concerning CT report quality, achieved an approval rate >85%. The colorectal cancer multidisciplinary team consultants who always or usually work with template style reporting of CT scans of colon cancer tend to be more satisfied with the quality and content of the reports, compared to those who rarely use or read template reports. CONCLUSION: The following indicators were insufficiently reported: tumor invasion growth; number of hepatic metastases; segment location of hepatic metastasis; and retroperitoneal lymph node involvement. In the template reports group, nearly all participants found relevant information easily accessible.

Diffusion-Weighted MRI as a Quantitative Imaging Biomarker in Colon Tumors.

PURPOSE: To assess the use of quantitative diffusion-weighted MRI (DW-MRI) as a diagnostic imaging biomarker in differentiating between benign colon adenoma, early, and advanced cancer of the colon, as well as predicting lymph node involvement, and finally comparing mucinous-producing colon cancer with adenomas and non-mucinous colon cancer. METHOD: Patients with a confirmed tumor on colonoscopy were eligible for inclusion in this study. Using a 3.0 Tesla MRI machine, the main tumor mean apparent diffusion coefficient (mADC) was obtained. Surgically resected tumor specimens served as an endpoint, except in mucinous colon cancers, which were classified based on T2 images. RESULTS: A total of 152 patients were included in the study population. The mean age was 71 years. A statistically significant mADC mean difference of -282 × 10-6 mm2/s [-419--144 95% CI, p < 0.001] was found between colon adenomas and early colon cancer, with an AUC of 0.80 [0.68-0.93 95% CI] and an optimal cut off value of 1018 × 10-6 mm2/s. Only a small statistically significant difference (p = 0.039) in mADC was found between benign tumors and mucinous colon cancer. We found no statistical difference in mADC mean values between early and advanced colon cancer, and between colon cancer with and without lymph node involvement. CONCLUSION: Quantitative DW-MRI is potentially useful for determining whether a colonic tumor is benign or malignant. Mucinous colon cancer shows less diffusion restriction when compared to non-mucinous colon cancer, a potential pitfall.

Diagnostic accuracy of pan-enteric capsule endoscopy and magnetic resonance enterocolonography in suspected Crohn's disease.

BACKGROUND AND AIMS: Magnetic resonance enterocolonography (MREC) and pan-enteric capsule endoscopy (CE) offers visualization of the entire gastrointestinal tract in a single examination. We examined the diagnostic accuracy of MREC and CE in patients with suspected Crohn's disease (CD). METHOD: In a prospective, blinded, multicenter study, we included patients with clinically suspected CD. Patients were examined with MREC, CE, and ileocolonoscopy (IC) within 2 weeks. The primary outcome was per patient sensitivity, specificity, and diagnostic accuracy for ileocolonic CD. IC served as reference standard. RESULTS: 153 patients were included in the study and IC, MREC, and CE was performed in 152, 151, 133 patients, respectively. CD was diagnosed with IC in 59 (39%) patients (terminal ileum (TI) 22, colon 20, TI and colon 17). The sensitivity and specificity for diagnosing ileocolonic CD with MREC was 67.9% (CI 53.7-80.1) and 76.3% (CI 65.2-85.3) (TI 76.9% and 85.6%; colon 27% and 93%) compared to 87.5% (CI 73.2-95.8) and 87.8% (CI 78.2-94.3) with CE (TI 96.6% and 87.5%; colon 75.0% and 93.0%). The sensitivity of CE was superior to that of MREC (p = 0.02). The patient experienced discomfort was equal with CE and MREC and significantly less than with IC. CONCLUSION: In patients with suspected CD, CE has a high sensitivity for diagnosing CD in the TI and colon, which is superior to that of MREC. The sensitivity of MREC for diagnosing CD in the colon is poor. CE could be a patient-friendly alternative to IC in selected patients with suspected CD. Registered at ClinicalTrials.gov: NCT03134586.

Endorectal Ultrasound Shear-Wave Elastography of Complex Rectal Adenoma and Early Rectal Cancer.

Purpose: To investigate the diagnostic performance of endorectal ultrasound (ERUS), shear-wave elastography (SWE), and magnetic resonance imaging (MRI) in patients with a complex rectal adenoma or an early rectal cancer, i.e., T1 or T2 adenocarcinoma in a clinical setting, and to evaluate the association between SWE and stromal fraction (SF) and apparent diffusion coefficient (ADC) and SF. Method: This prospective study included patients undergoing ERUS and SWE for a rectal tumor subsequently confirmed by histopathology to be an adenoma or a T1 or T2 adenocarcinoma. The accuracy of the imaging methods was assessed by comparing the T category as determined by ERUS and MRI with histopathology, which served as the gold standard. SF was assessed on surgical specimens. Results: A total of 86 patients were included. Of these, 62 patients had adenomas and 24 patients had carcinomas, of which 11 were T1 tumors and 13 were T2 tumors. ERUS and MRI yielded sensitivity, specificity, and accuracy of 0.79 and 0.73, 0.95 and 0.90, and 0.86 and 0.78, respectively, for discrimination between benign and malignant lesions. The area under the receiver operating characteristics curve for SWE was 0.88, and with a cut-off value of 40 kPa the sensitivity, specificity, and accuracy were 0.79, 0.89, and 0.86, respectively. There was a positive correlation between SF and SWE with a p-value of <0.001 and a negative correlation between SF and ADC with a p-value of 0.011. Conclusion: Both ERUS and MRI classified T categories with a high accuracy; however, ERUS classified more adenomas correctly than MRI. In this small population, SWE could differentiate an adenoma from early carcinoma. SF was correlated with both SWE and ADC, as increasing SF tended to yield higher SWE and lower ADC values.

Intra- and Interobserver Variability of Shear Wave Elastography in Rectal Cancer.

BACKGROUND: Endorectal ultrasound (ERUS) is an important tool when evaluating complex rectal adenomas and rectal cancer, and the accuracy is improved by adding elastography measurements. A high interobserver agreement is imperative in clinical practice. Therefore, the aim of this study was to evaluate interobserver agreement assessed on real-time images. Additionally, we investigated the intra- and interobserver agreement between experienced and inexperienced observers. MATERIALS AND METHODS: We prospectively included patients referred to an ERUS at the Department of Radiology with a complex rectal polyp or suspected rectal malignancy. Two operators independently scanned each patient in turn. Furthermore, four observers assessed previously obtained images using three different methods for placing the region of interest (ROI). Three months later, the four observers reassessed the images to assess intraobserver variability. RESULTS: A total of 19 patients were included for live assessment. Agreement of tumor classification was substantial for T stage (kappa: 0.86) and fair for N stage (kappa: 0.73), with an absolute agreement for T and N stages of 84% and 89%, respectively. Agreement of SWE was good for Emean (ICC 0.94, 95% CI 0.86-0.98) and fair for Emax (ICC 0.85, 95% CI 0.66-0.94). Intra- and interobserver agreement between inexperienced and experienced observers showed good to excellent agreement with all ROI methods. CONCLUSION: Interobserver agreement is high in SWE when performed in a clinical setting. We found the best agreement using the mean value of several ROIs. Intra- and interobserver agreement was high regardless of operator experience.

Interobserver Reliability and the Sigmoid Takeoff-An Interobserver Study.

Background: Colorectal cancer is the second most common cancer worldwide. The sigmoid takeoff is the landmark where the colon sigmoid curves toward the sacrum viewed from sagittal magnetic resonance imaging (MRI). The purpose of this study was to assess interobserver variability in the assessment of the anal verge and anorectal junction in patients diagnosed with rectal cancer on magnetic resonance imaging (MRI). Materials and Methods: The rectal MRI examinations were performed using a 1.5- or 3.0-tesla unit using an anterior coil and a standard scan protocol. Two senior radiologists assessed MRI scans from patients under investigation for rectal cancer. The two observers assessed the anal verge and takeoff in cm independently. Difference in agreement between the observers were evaluated using intraclass correlation (ICC) and graphically by Bland-Altman plots. Results: The study population (n = 122) included 68 (55.7%) female and 54 (44.3%) male subjects. The overall median age was 69.5 years (range 39-95 years). There was perfect agreement between the two observers when defining rectal tumor above or below the takeoff landmark. The reliability of measuring the distance from the anal verge to the sigmoid takeoff was 0.712. Conclusion: Overall, the study found a moderate reliability in assessing the location of the sigmoid takeoff, with a low difference in the distance measuring, as well as a good consensus concerning the determination of tumors in relation to the sigmoid takeoff. Routine implementation of this information within the report seems reasonable.

Management and follow-up of gallbladder polyps: updated joint guidelines between the ESGAR, EAES, EFISDS and ESGE.

MAIN RECOMMENDATIONS: 1. Primary investigation of polypoid lesions of the gallbladder should be with abdominal ultrasound. Routine use of other imaging modalities is not recommended presently, but further research is needed. In centres with appropriate expertise and resources, alternative imaging modalities (such as contrast-enhanced and endoscopic ultrasound) may be useful to aid decision-making in difficult cases. Strong recommendation, low-moderate quality evidence. 2. Cholecystectomy is recommended in patients with polypoid lesions of the gallbladder measuring 10 mm or more, providing the patient is fit for, and accepts, surgery. Multidisciplinary discussion may be employed to assess perceived individual risk of malignancy. Strong recommendation, low-quality evidence. 3. Cholecystectomy is suggested for patients with a polypoid lesion and symptoms potentially attributable to the gallbladder if no alternative cause for the patient's symptoms is demonstrated and the patient is fit for, and accepts, surgery. The patient should be counselled regarding the benefit of cholecystectomy versus the risk of persistent symptoms. Strong recommendation, low-quality evidence. 4. If the patient has a 6-9 mm polypoid lesion of the gallbladder and one or more risk factors for malignancy, cholecystectomy is recommended if the patient is fit for, and accepts, surgery. These risk factors are as follows: age more than 60 years, history of primary sclerosing cholangitis (PSC), Asian ethnicity, sessile polypoid lesion (including focal gallbladder wall thickening > 4 mm). Strong recommendation, low-moderate quality evidence. 5. If the patient has either no risk factors for malignancy and a gallbladder polypoid lesion of 6-9 mm, or risk factors for malignancy and a gallbladder polypoid lesion 5 mm or less, follow-up ultrasound of the gallbladder is recommended at 6 months, 1 year and 2 years. Follow-up should be discontinued after 2 years in the absence of growth. Moderate strength recommendation, moderate-quality evidence. 6. If the patient has no risk factors for malignancy, and a gallbladder polypoid lesion of 5 mm or less, follow-up is not required. Strong recommendation, moderate-quality evidence. 7. If during follow-up the gallbladder polypoid lesion grows to 10 mm, then cholecystectomy is advised. If the polypoid lesion grows by 2 mm or more within the 2-year follow-up period, then the current size of the polypoid lesion should be considered along with patient risk factors. Multidisciplinary discussion may be employed to decide whether continuation of monitoring, or cholecystectomy, is necessary. Moderate strength recommendation, moderate-quality evidence. 8. If during follow-up the gallbladder polypoid lesion disappears, then monitoring can be discontinued. Strong recommendation, moderate-quality evidence. SOURCE AND SCOPE: These guidelines are an update of the 2017 recommendations developed between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery-European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). A targeted literature search was performed to discover recent evidence concerning the management and follow-up of gallbladder polyps. The changes within these updated guidelines were formulated after consideration of the latest evidence by a group of international experts. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. KEY POINT: • These recommendations update the 2017 European guidelines regarding the management and follow-up of gallbladder polyps.

Intra- and Interobserver Variability in Magnetic Resonance Imaging Measurements in Rectal Cancer Patients.

Colorectal cancer is the second most common cancer in Europe, and accurate lymph node staging in rectal cancer patients is essential for the selection of their treatment. MRI lymph node staging is complex, and few studies have been published regarding its reproducibility. This study assesses the inter- and intraobserver variability in lymph node size, apparent diffusion coefficient (ADC) measurements, and morphological characterization among inexperienced and experienced radiologists. Four radiologists with different levels of experience in MRI rectal cancer staging analyzed 36 MRI scans of 36 patients with rectal adenocarcinoma. Inter- and intraobserver variation was calculated using interclass correlation coefficients and Cohens-kappa statistics, respectively. Inter- and intraobserver agreement for the length and width measurements was good to excellent, and for that of ADC it was fair to good. Interobserver agreement for the assessment of irregular border was moderate, heterogeneous signal was fair, round shape was fair to moderate, and extramesorectal lymph node location was moderate to almost perfect. Intraobserver agreement for the assessment of irregular border was fair to substantial, heterogeneous signal was fair to moderate, round shape was fair to moderate, and extramesorectal lymph node location was substantial to almost perfect. Our data indicate that subjective variables such as morphological characteristics are less reproducible than numerical variables, regardless of the level of experience of the observers.

Ultrasound and contrast enhanced CT imaging of a colon mesentery leiomyosarcoma.

Primary leiomyosarcoma of the colon mesentery is an extremely rare neoplasm, and only a small number of cases have been reported. We describe a case of leiomyosarcoma originating in the colonic mesentery, in a 68-year-old woman. Ultrasound showed a heterogeneous mass with varying vascularization in the left fossa. Central areas of the mass were hypoechoic, without detectable vascularization. Contrast enhanced computed tomography (CECT) of chest and abdomen showed a contrast enhanced tumour, with central non-enhanced areas. The tumour was radically resected and histopathology showed primary leiomyosarcoma. Two years after primary surgery, follow-up CECT revealed a local recurrence, which was re-resected. Subsequent follow-up CECT since have shown no sign of recurrence.

The Impact of Patient Characteristics and Tumor Biology on the Accuracy of Preoperative Staging of Colon Cancer in Denmark. A Nationwide Cohort Study.

BACKGROUND: Colon cancer is a common disease in western populations. The aim of this study was to assess the impact of mismatch repair (MMR) deficiency and other patient and tumor characteristics on the accuracy of preoperative staging by comparing histopathological T- and N-categories of the resected specimen with the preoperative clinical stage in a nationwide cohort of patients treated for colon cancer by elective bowel resection with curative intent. METHODS: A register study of a cohort extracted from the Danish Colorectal Cancer Group (DCCG) database, which holds prospective data on all new cases of colon and rectum cancer in Denmark. Patients diagnosed with colon cancer and treated with an elective bowel resection with curative intent in the years 2016-2019 were analyzed. RESULTS: A total of 6102 patients were included (n = 3161 (52%) men and n = 2941 (48%) women) with a median age of 72 years (range 23-97 years). MMR was deficient in 24% of the patients and proficient in 76%. MMR deficiency, tumor sidedness and histopathological type were significant predictors of the accuracy of preoperative staging of colon cancer in univariate and multivariate analysis. MMR status in particular showed a strong impact on the risk of overstaging. CONCLUSIONS: MMR deficiency, but also tumor sidedness and to some degree histopathological type, impacted the accuracy of preoperative staging of colon cancer. MMR status should be taken into consideration in everyday clinical staging.

Can Ultrasound Elastography Discriminate between Rectal Adenoma and Cancer? A Systematic Review.

BACKGROUND: Rectal cancer is a common malignancy. Since the introduction of bowel-screening programs, the number of patients with advanced adenomas and early rectal cancer has increased. Despite improved diagnostics, the discrimination between rectal adenomas and early rectal cancer (i.e., pT1-T2) remains challenging. The purpose of this systematic review was to evaluate the diagnostic performance of endorectal ultrasound (ERUS) elastography in discriminating rectal adenomas from cancer. METHOD: Using PRISMA guidelines, a systematic search was performed on PubMed, Embase, and MEDLINE databases. Studies evaluating the primary staging of rectal adenomas and cancer using ERUS elastography were included. RESULTS: Six studies were identified; three evaluated the discrimination between adenomas and cancer; two evaluated adenomas and early rectal cancer (i.e., pT1-T2); one evaluated performance on different T categories. All studies reported increased diagnostic accuracy of ERUS elastography compared to ERUS. Sensitivity, specificity and accuracy ranged 0.93-1.00, 0.83-1.00 and 0.91-1.00, respectively, when discriminating adenomas from cancer. In the differentiation between adenomas and early rectal cancer, the sensitivity, specificity and accuracy were 0.82-1.00, 0.86-1.00 and 0.84-1.00, respectively. CONCLUSION: Elastography increases the accuracy of ERUS and may provide valuable information on malignant transformation of rectal lesions.

Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin: a non-randomised phase II clinical trial.

INTRODUCTION: Skin malignancy is a distressing problem for many patients, and clinical management is challenging. This article describes the protocol for the Calcium Electroporation Response Study (CaEP-R) designed to investigate tumour response to calcium electroporation and is a descriptive guide to calcium electroporation treatment of malignant tumours in the skin. Calcium electroporation is a local treatment that induces supraphysiological intracellular calcium levels by intratumoural calcium administration and application of electrical pulses. The pulses create transient membrane pores allowing diffusion of non-permeant calcium ions into target cells. High calcium levels can kill cancer cells, while normal cells can restore homeostasis. Prior trials with smaller cohorts have found calcium electroporation to be safe and efficient. This trial aims to include a larger multiregional cohort of patients with different cancer diagnoses and also to investigate treatment areas using MRI as well as assess impact on quality of life. METHODS AND ANALYSIS: This non-randomised phase II multicentre study will investigate response to calcium electroporation in 30 patients with cutaneous or subcutaneous malignancy. Enrolment of 10 patients is planned at three centres: Zealand University Hospital, University Hospital of Southern Denmark and University Hospital Schleswig-Holstein. Response after 2 months was chosen as the primary endpoint based on short-term response rates observed in a prior clinical study. Secondary endpoints include response to treatment using MRI and change in quality of life assessed by questionnaires and qualitative interviews. ETHICS AND DISSEMINATION: The trial is approved by the Danish Medicines Agency and The Danish Regional Committee on Health Research Ethics. All included patients will receive active treatment (calcium electroporation). Patients can continue systemic treatment during the study, and side effects are expected to be limited. Data will be published in a peer-reviewed journal and made available to the public. TRIAL REGISTRATION NUMBERS: NCT04225767 and EudraCT no: 2019-004314-34.

Shorter anogenital distance is observed in patients with testicular microlithiasis using magnetic resonance imaging.

OBJECTIVE: To investigate the anogenital distance in patients with and without testicular microlithiasis (TML). METHODS: A total of 101 patients underwent a conventional standard clinical B-mode scrotal ultrasonography and scrotal MRI. The patients were divided into two groups: patients with TML and non-TML. The latter served as control group. The anogenital distance was measured by a straight line from center of the anus to the posterior base of scrotum using MRI. RESULTS: In the TML group, mean AGD was 5.4 (± 1.07) cm (range 29-79 mm), and in non-TML 5.9 (± 1.03) cm (range 35-85 mm) (p = 0.04). CONCLUSION: MRI is a useful tool to measure the AGD. It is easy to perform without any discomfort to patients. We found AGD to be lower in patients with TML.