Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

Perinatal mortality: clinical value of postmortem magnetic resonance imaging compared with autopsy in routine obstetric practice

Objective To compare postmortem magnetic resonance imaging (MRI) with autopsy in perinatal deaths. To determine the acceptance and feasibility of postmortem perinatal MRI. Design Cohort study. Setting Large teaching hospital. Population Fetuses and neonates from 16 weeks gestational age until 28 days after birth, stillbirths as well as intrapartum and neonatal deaths. Methods MRI was performed prior to autopsy in a consecutive cohort of perinatal deaths after full parental consent. Agreement between MRI and autopsy was calculated. The consent rate for both examinations was recorded separately, as well as the time between the perinatal death and the MRI. Main outcome measure Full agreement between MRI and autopsy. Results Of 58 cases, 26 parents consented to both examinations (45%). Autopsy showed 18 major malformations, of which 10 were detected with MRI. The positive predictive value of MRI was 80% (4/5) and the negative predictive value was 65% (13/20). Additional consent for MRI was given in eight cases (14%). In 84%, the MRI could be performed within 48 hours. Conclusions MRI is of value if autopsy is refused, but diagnostic accuracy is insufficient to recommend substitution of full autopsy. The acceptance rate of MRI only is better than that of autops

Image quality and patient acceptance of four regimens with different amounts of mild laxatives for CT colonography

OBJECTIVE: The purpose of our study was to prospectively evaluate image quality and patient acceptance of CT colonography (CTC) with fecal tagging using different levels of catharsis. SUBJECTS AND METHODS: Forty consecutive increased-risk patients were randomized. Group 1 received orally 20 mg of bisacodyl, group 2 received 30 mg of bisacodyl, group 3 received 20 mg of bisacodyl and 8.2 g of magnesium citrate, and group 4 received 30 mg of bisacodyl and 16.4 g of magnesium citrate. All patients used a 2-day low-fiber diet and received diatrizoate meglumine and barium for fecal tagging. One reviewer blindly scored subjective image quality (fecal tagging, amount of residual feces [liquid or solid], luminal distention, and image readability) on a 5- to 6-point scale using a 2D review technique. The mean and SD of attenuation of tagging were measured as well as the relative SD as a measure of homogeneity. Furthermore, patient acceptance (burden related to diarrhea, abdominal pain, flatulence, and overall burden) was evaluated. Ordinal regression, generalized estimating equations, and parametric and nonparametric tests were used for analysis. RESULTS: Image readability was evaluated as good or excellent in all examinations except one in group 2 (nondiagnostic) and two in group 3 (moderate). Group 2 contained more feces than group 4 (p = 0.04). With regard to mean attenuation and homogeneity of tagging, no significant differences were observed between groups. Group 4 experienced more severe diarrhea than groups 1 and 2 and higher overall burden than groups 1 and 3 (p < 0.042). CONCLUSION: The mildest preparation with 20 mg of bisacodyl provided good image quality of CTC images. Increasing the amount of laxatives did not improve image quality or tagging characteristics but was associated with a lower patient acceptanc

CT colonography with limited bowel preparation: prospective assessment of patient experience and preference in comparison to optical colonoscopy with cathartic bowel preparation

The purpose of this study was to prospectively compare participant experience and preference of limited preparation computed tomography colonography (CTC) with full-preparation colonoscopy in a consecutive series of patients at increased risk of colorectal cancer. CTC preparation comprised 180 ml diatrizoate meglumine, 80 ml barium and 30 mg bisacodyl. For the colonoscopy preparation 4 l of polyethylene glycol solution was used. Participants' experience and preference were compared using the Wilcoxon signed rank test and the chi-squared test, respectively. Associations between preference and experience parameters for the 173 participants were determined by logistic regression. Diarrhoea occurred in 94% of participants during CTC preparation. This side effect was perceived as severely or extremely burdensome by 29%. Nonetheless, the total burden was significantly lower for the CTC preparation than for colonoscopy (9% rated the CTC preparation as severely or extremely burdensome compared with 59% for colonoscopy; p <0.001). Participants experienced significantly more pain, discomfort and total burden with the colonoscopy procedure than with CTC (p <0.001). After 5 weeks, 69% preferred CTC, 8% were indifferent and 23% preferred colonoscopy (p <0.001). A burdensome colonoscopy preparation and pain at colonoscopy were associated with CTC preference (p <0.04). In conclusion, participants' experience and preference were rated in favour of CTC with limited bowel preparation compared with full-preparation colonoscop