Preoperative Predictors of Neoplasia in Patients Undergoing Small Bowel Resection for Complicated Crohn's Disease: A Multicentre Case-Control Study.

Crohn's disease (CD) is associated with an increased risk of small bowel neoplasia (SBN). We aimed to assess preoperative predictors of SBN in CD patients. We conducted a retrospective case-control study including CD patients who underwent surgery: cases were diagnosed with SBN on histopathological analysis and controls had no neoplasia. Preoperative cross-sectional imaging was reviewed by a panel of blinded expert radiologists. Fifty cases were matched to one hundred and fifty consecutive controls. In multivariable analysis, predictors of SBN were age ≥ 50 years (OR = 28, 95% CI = 5.05-206), median CD duration ≥ 17.5 years (OR = 4.25, 95% CI = 1.33-14.3), and surgery for stricture (OR = 5.84, 95% CI = 1.27-35.4). The predictors of small bowel adenocarcinoma were age ≥ 50 years (OR = 5.14, 95% CI = 2.12-12.7), CD duration ≥ 15 years (OR = 5.65, 95% CI = 2.33-14.3), and digestive wall thickening > 8 mm (OR = 3.79, 95% CI = 1.45-11.3). A predictive score based on the aforementioned factors was constructed. Almost 73.7% of patients with a high score had SBA. Old age, long small bowel CD duration, and stricture predicted the presence of SBN, particularly adenocarcinoma when patients have digestive wall thickening > 8 mm on preoperative imaging.

Feasibility study of a Response Surveillance Program in locally advanced mid and low rectal cancer to increase organ preservation.

BACKGROUND: Assessment of tumor response in rectal cancer after neoadjuvant treatment by MRI (Tumour Regression Grade, TRG 1-5) is well standardized. The overall timing and method of defining complete response (cCR) remain controversial. The aim of this work was to evaluate the feasibility of a defined Response Surveillance Program (RSP) to increase organ preservation for locally advanced rectal cancer after neoadjuvant treatment. METHODS: A standardized program of clinical (CR), radiological (RR) and metabolic (MR) assessment of tumor response is defined over a 6 month period from completion of NACRT with formal assessment performed every 2 months (M). Patients with TRG1-3 at M2 and TRG1-2 at M4 continue in the program up to M6 assessment. Patients managed with this protocol from 2016 to 2020 were analyzed. The primary endpoint was rectal preservation rate. Secondary endpoints included disease-free survival and overall survival at 3 years. RESULT: 314 potentially suitable patients were enrolled in the RSP and 50 patients completed the six month program and were successfully enrolled into watch and wait. Fourteen (28%) were T2 tumor stage, 27 (54%) T3 and nine (18%) were T4. During watch and wait, patients with locoregional recurrence (n = 11) were treated with local excision (n = 3), endocavitary radiotherapy (n = 1), TME (n = 5) and APR (n = 2). With a median follow-up of 32 months, the rectal preservation rate was 88%, with a 3-year disease-free survival of 67% and an overall survival of 98%. CONCLUSION: This study validates the feasibility of the practical implementation of a Response Surveillance Program to increase organ preservation rates without compromising oncological outcomes in rectal cancer.

Structured and shared MRI staging lexicon and report of rectal cancer: A consensus proposal by the French Radiology Group (GRERCAR) and Surgical Group (GRECCAR) for rectal cancer.

PURPOSE: To develop French guidelines by experts to standardize data acquisition, image interpretation, and reporting in rectal cancer staging with magnetic resonance imaging (MRI). MATERIALS AND METHODS: Evidence-based data and opinions of experts of GRERCAR (Groupe de REcherche en Radiologie sur le CAncer du Rectum [i.e., Rectal Cancer Imaging Research Group]) and GRECCAR (Groupe de REcherche en Chirurgie sur le CAncer du Rectum [i.e., Rectal Cancer Surgery Research Group]) were combined using the RAND-UCLA Appropriateness Method to attain consensus guidelines. Experts scoring of reporting template and protocol for data acquisition were collected; responses were analyzed and classified as "Recommended" versus "Not recommended" (when ≥ 80% consensus among experts) or uncertain (when < 80% consensus among experts). RESULTS: Consensus regarding patient preparation, MRI sequences, staging and reporting was attained using the RAND-UCLA Appropriateness Method. A consensus was reached for each reporting template item among the experts. Tailored MRI protocol and standardized report were proposed. CONCLUSION: These consensus recommendations should be used as a guide for rectal cancer staging with MRI.

The feasibility of implementing an enhanced recovery programme in patients undergoing pelvic exenteration.

BACKGROUND: Pelvic exenteration (PE) is a complex operative procedure, reserved for patients with locally advanced and recurrent pelvic malignancies. PE is associated with a high index of post-operative morbidity. Enhanced Recovery After Surgery (ERAS) programmes have been successful in improving postoperative outcomes, however, its application in PE has not been studied. The aim of our study is to assess the feasibility and short-term impact of ERAS on PE. METHODS: A dedicated PE ERAS programme was developed reflecting the complexity of differing subtypes of PE. A prospective cohort study was undertaken to evaluate the feasibility of implementing our PE ERAS between 2016 and 2020. The primary endpoint of this study was overall compliance with the ERAS programme. RESULTS: 145 patients were enrolled into our PE ERAS programme, with 86 (56.2%) patients undergoing a soft tissue PE, 27 (17.6%) a vascular PE and 32 (20.9%) a bony PE. The median overall compliance to the PE ERAS programme was 70% (IQR 55.5-88.8). There were no observed differences between overall compliance to the PE ERAS programme between different subtypes of PE (p = 0.60). Patients with higher compliance with the PE ERAS programme had a shorter LoS (p < 0.001), less post-operative morbidity (p < 0.001), reduced severity of Clavien-Dindo grade of morbidity (p < 0.001) and fewer readmissions (p = 0.03). CONCLUSIONS: The principles of ERAS can be readily applied to patients undergoing PE, with high adherence to the ERAS programme associated with improved clinical outcomes.

A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol.

AIM: Treatment strategies in locally recurrent rectal cancer (LRRC) are complex and need to be balanced against previous treatments received for the primary rectal cancer. Radiotherapy is an important component of treatment in LRRC. However, there is little high-quality evidence on the role of reirradiation in this cohort. Therefore, the aim of this trial is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC. METHOD: GRECCAR 15 is a prospective, multicentre, open-label, outcome assessor-blinded, superiority randomized controlled phase III clinical trial comparing neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone in patients with LRRC previously irradiated for the primary cancer. Adult patients (>18 years old) with a histologically proven resectable LRRC, who have previously received pelvic radiotherapy for their primary rectal cancer at a dose of 25-50.4 Gy, and an Eastern Cooperative Oncology Group performance status of <2 will be eligible to participate. The pelvic reirradiation will consist of conformational intensity-modulated external irradiation, delivering a dose of 30.6 Gy with concomitant chemotherapy using capecitabine. The primary outcome of this trial is the R0 resection rate. Overall, GRECCAR 15 aims to recruit 186 patients to detect an absolute difference of 20% in the R0 resection rate with 80% power and 5% two-sided significance level. CONCLUSION: The GRECCAR 15 trial is the first, definitive, phase III trial to investigate reirradiation in LRRC. The results of this trial will inform definitively the neoadjuvant treatment strategy in previously irradiated patients and assess whether there is any associated benefit of reirradiation in combination with induction chemotherapy in improving R0 resection rates.

Liver contrast-enhanced sonography: computer-assisted differentiation between focal nodular hyperplasia and inflammatory hepatocellular adenoma by reference to microbubble transport patterns.

OBJECTIVE: A new computer tool is proposed to distinguish between focal nodular hyperplasia (FNH) and an inflammatory hepatocellular adenoma (I-HCA) using contrast-enhanced ultrasound (CEUS). The new method was compared with the usual qualitative analysis. METHODS: The proposed tool embeds an "optical flow" algorithm, designed to mimic the human visual perception of object transport in image series, to quantitatively analyse apparent microbubble transport parameters visible on CEUS. Qualitative (visual) and quantitative (computer-assisted) CEUS data were compared in a cohort of adult patients with either FNH or I-HCA based on pathological and radiological results. For quantitative analysis, several computer-assisted classification models were tested and subjected to cross-validation. The accuracies, area under the receiver-operating characteristic curve (AUROC), sensitivity and specificity, positive predictive values (PPVs), negative predictive values (NPVs), false predictive rate (FPRs) and false negative rate (FNRs) were recorded. RESULTS: Forty-six patients with FNH (n = 29) or I-HCA (n = 17) with 47 tumours (one patient with 2 I-HCA) were analysed. The qualitative diagnostic parameters were accuracy = 93.6%, AUROC = 0.94, sensitivity = 94.4%, specificity = 93.1%, PPV = 89.5%, NPV = 96.4%, FPR = 6.9% and FNR = 5.6%. The quantitative diagnostic parameters were accuracy = 95.9%, AUROC = 0.97, sensitivity = 93.4%, specificity = 97.6%, PPV = 95.3%, NPV = 96.7%, FPR = 2.4% and FNR = 6.6%. CONCLUSIONS: Microbubble transport patterns evident on CEUS are valuable diagnostic indicators. Machine-learning algorithms analysing such data facilitate the diagnosis of FNH and I-HCA tumours. KEY POINTS: • Distinguishing between focal nodular hyperplasia and an inflammatory hepatocellular adenoma using dynamic contrast-enhanced ultrasound is sometimes difficult. • Microbubble transport patterns evident on contrast-enhanced sonography are valuable diagnostic indicators. • Machine-learning algorithms analysing microbubble transport patterns facilitate the diagnosis of FNH and I-HCA.

Magnetic resonance texture parameters are associated with ablation efficiency in MR-guided high-intensity focussed ultrasound treatment of uterine fibroids.

OBJECTIVES: The objective of this study is to assess the association between texture parameter analysis derived from T2-weighted images and efficiency of magnetic resonance-guided focussed ultrasound (MRgFUS) ablation for the treatment of uterine fibroids. MATERIALS AND METHODS: Fifty-five women treated by MRgFUS were included in this retrospective analysis. Texture parameters were calculated using three 2D regions of interest placed on three consecutive slices on the same sagittal 3D T2-weighted images obtained at the beginning of MRgFUS ablation. Using uni- and multi-variate linear regression, texture parameters, fibroids/muscular T2W ratio (T2Wr), Funaki type, and fibroid depth were correlated with ablation efficiency, defined as the ratio of non-perfused volume (NPV) on post-treatment contrast-enhanced MRI by total volume of treatment-cell sizes used. Inter-rater reproducibility for texture analysis was assessed using variation coefficients. RESULTS: The mean total treatment cell volume was 49.5 (±30) ml, corresponding to a mean NPV of 57.2 (±57) ml (28%). The mean ablation efficiency was 1.14 (±0.7), with a range of 0.03-3.6. In addition to fibroid/muscular T2Wr, seven of the 14 texture parameters were significantly correlated with ablation efficiency: mean signal intensity (p = .047); Skewness (p = .03); Kurtosis (p = .015); mean uniformity (p = .052); mean sum of square (p = .045); mean sum entropy (p = .021) and mean entropy (p = .051). In multivariate linear regression, fibroid/muscular T2Wr and sum of entropy were associated with ablation efficiency. The inter-rater coefficient of variation for sum entropy was 2.6%. CONCLUSIONS: Uterine fibroid texture parameters provide complementary information to T2Wr, and are associated with MRgFUS efficiency. Key points Mean sum entropy is negatively correlated with MRgFUS efficiency (ρ = -0.307, p = .021). Fibroids/muscular T2-weighted ratio and entropy are associated with MRgFUS efficiency. Texture parameters are better predictors of MRgFUS efficiency than Funaki type. Fibroid MR texture analysis can improve patient selection for MRgFUS.

Transarterial chemoembolization for early stage hepatocellular carcinoma decrease local tumor control and overall survival compared to radiofrequency ablation.

BACKGROUND & AIMS: To compare treatment failure and survival associated with ultrasound-guided radiofrequency ablation (RFA) and trans-arterial chemoembolization (TACE) for early-stage HCC in Child-Pugh A cirrhosis patients. METHODS: 122 cirrhotic patients (RFA: 61; TACE: 61) were well matched according to cirrhosis severity; tumor size and serum alpha-fetoprotein. TACE was performed in case of inconspicuous nodule on US or nodule with "at risk location". Treatment failure was defined as local tumor progression (LTP) and primary treatment failure (failing to obtain complete response after two treatment session). Treatment failure and overall survival (OS) were compared after coarsened exact matching. Cox proportional model to assess independent predictive factors was performed. RESULTS: No significant difference was seen for baseline characteristics between the two groups. Mean tumor size was 3cm in both group with 41% HCC>3cm. Treatment failure rates after TACE was 42.6% (14 primary treatment failures and 12 LTP) and 9.8% after RFA (no primary treatment failure and 6 LTP) P < 0.001. TACE was the only predictive factor of treatment failure (Hazard ratio: 5.573). The 4-years OS after RFA and TACE were 54.1% and 31.5% (P = 0.042), respectively. CONCLUSION: For Child-Pugh A patients with early-stage HCC, alternative treatment as supra-selective TACE to RFA regarded as too challenging using common US guidance decrease significantly the local tumor control and overall survival. Efforts to improve feasibility of RFA especially for inconspicuous target have to be made.

Three-Dimensional Measurement of Hepatocellular Carcinoma Ablation Zones and Margins for Predicting Local Tumor Progression.

PURPOSE: To propose a postprocessing technique that measures tumor surface with insufficient ablative margins (≤ 5 mm) on magnetic resonance (MR) imaging to predict local tumor progression (LTP) following radiofrequency (RF) ablation. MATERIALS AND METHODS: A diagnostic method is proposed based on measurement of tumor surface with a margin ≤ 5 mm on MR imaging. The postprocessing technique includes fully automatic registration of pre- and post-RF ablation MR imaging, a semiautomatic segmentation of pre-RF ablation tumor and post-RF ablation volume, and a subsequent calculation of the three-dimensional exposed tumor surface area. The ability to use this surface margin ≤ 5 mm to predict local recurrence at 2 years was then tested on 16 patients with cirrhosis who were treated by RF ablation with a margin ≤ 5 mm in 2012: eight with LTP matched according to tumor size and number and α-fetoprotein level versus eight without local recurrence. RESULTS: The error of estimated tumor surface with a margin ≤ 5 mm was less than 12%. Results of a log-rank test showed that patients with a tumor surface area > 425 mm(2) had a 2-year LTP rate of 77.5%, compared with 25% for patients with a tumor surface area ≤ 425 mm(2) (P = .018). CONCLUSIONS: This proof-of-concept study proposes an accurate and reliable postprocessing technique to estimate tumor surface with insufficient ablative margins, and underscores the potential usefulness of tumor surface with a margin ≤ 5 mm to stratify patients with HCC treated by RF ablation according to their risk of LTP.

Magnetic resonance-guided high-intensity focused ultrasound for uterine fibroids: Mid-term outcomes of 36 patients treated with the Sonalleve system.

OBJECTIVES: This study sought to assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MRgFUS) (Sonalleve system) for uterine fibroids. METHODS: We retrospectively included patients treated by MRgFUS controlled by real-time MR-thermometry. Clinical efficacy was defined as the minimum reduction of ten points in the Transformed Symptom Severity Score (tSSS) without additional treatment. Fibroid volumes were assessed at 6 months, and patients were contacted to assess mid-term efficacy using tSSS. RESULTS: Thirty-six patients were included; 22 patients (61.1%) exhibited clinical efficacy with a mean follow-up duration of 21.4 (95%CI: 16.3-26.5) months. In addition, the tSSS mean decreased significantly from 42.8 ± 16 to 25.4 ± 18 (p < 0.0001). MRgFUS exhibited a preferential effect on menorrhagia (p = 0.001) and symptoms related to pelvic heaviness and swelling (p = 0.004). The volume reduction was 27% (p < 0.001) and was correlated with the non-perfused volume (NPV) after treatment (r = 0.373; p = 0.028). Cumulative re-intervention rates (surgery or uterine artery embolisation) at 12 months, 18 months and 24 months were 2.8%, 8.5% and 21.6%, respectively. No serious adverse events were reported. Two pregnancies occurred during the follow-up period. CONCLUSIONS: Treatment of uterine fibroids by MRgFUS is efficient and results in low morbidity and satisfactory clinical efficacy with a mean follow-up of 21.4 months.

Radiofrequency ablation versus surgical resection for hepatocellular carcinoma within the Milan criteria: A study of 281 Western patients.

OBJECTIVES: The aim of this study was to compare survival between radiofrequency ablation (RFA) and surgical resection (SR) in patients with hepatocellular carcinoma (HCC) within Milan criteria. METHODS: From January 2004 to December 2013 we consecutively and retrospectively included all patients with first occurrence of HCC within Milan criteria receiving SR or RFA as first-line treatment. The cumulative overall survival (OS) and disease-free survival (DFS) were compared after inverse probability weighting (including confounding factor). RESULTS: A total of 281 patients (RFA 178, SR 103) were enrolled. In multivariate Cox regression RFA and SR were not independent predictors of survival or recurrence. The respective weighted 5 years OS and DFS for patients with propensity scores between 0.1-0.9 in the SR and RFA groups were 54-33% and 60-16.9%, P = 0.695 and P = 0.426, respectively. Local tumour progression rate did not differ according to treatment (P = 0.523). Major complication rate was higher in the SR group, P = 0.001. Hospitalisation duration was lower in the RFA group (mean 2.19 days, range 2-7) than in the SR group (mean 10.2 days, range 3-30), P < 0.001. CONCLUSION: This large Western study has shown that OS and DFS did not differ after RFA (using mainly multipolar devices) and SR, for HCC within the Milan criteria in a European population, with a shorter hospitalisation time and a lower complication rate for RFA.