Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial.

BACKGROUND: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. TRIAL REGISTRATION: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.

IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol.

BACKGROUND: Anastomotic leakage (AL) is still a common and feared complication after low anterior resection (LAR) for rectal cancer. The multifactorial pathophysiology of AL and lack of standardised treatment options requires a multi-modal approach to improve long-term anastomotic integrity. The objective of the IMARI-trial is to determine whether the one-year anastomotic integrity rate in patients undergoing LAR for rectal cancer can be improved using a multi-interventional program. METHODS: IMARI is a multicentre prospective clinical effectiveness trial, whereby current local practice (control cohort) will be evaluated, and subsequently compared to results after implementation of the multi-interventional program (intervention cohort). Patients undergoing LAR for rectal cancer will be included. The multi-interventional program includes three preventive interventions (mechanical bowel preparation with oral antibiotics, tailored full splenic flexure mobilization and intraoperative fluorescence angiography using indocyanine green) combined with a standardised pathway for early detection and active management of AL. The primary outcome is anastomotic integrity, confirmed by CT-scan at one year postoperatively. Secondary outcomes include incidence of AL, protocol compliance and association with AL, temporary and permanent stoma rate, reintervention rate, quality of life and functional outcome. Microbiome analysis will be conducted to investigate the role of the rectal microbiome in AL. In a Dutch nationwide study, the AL rate was 20%, with anastomotic integrity of 90% after one year. Based on an expected reduction of AL due to the preventive approaches of 50%, and increase of anastomotic integrity by a standardised pathway for early detection and active management of AL, we hypothesised that the anastomotic integrity rate will increase from 90 to 97% at one year. An improvement of 7% in anastomotic integrity at one year was considered clinically relevant. A total number of 488 patients (244 per cohort) are needed to detect this difference, with 80% statistical power. DISCUSSION: The IMARI-trial is designed to evaluate whether a multi-interventional program can improve long-term anastomotic integrity after rectal cancer surgery. The uniqueness of IMARI lies in the multi-modal design that addresses the multifactorial pathophysiology for prevention, and a standardised pathway for early detection and active treatment of AL. TRIAL REGISTRATION: Trialregister.nl ( NL8261 ), January 2020.

Evaluation of compressed sensing MRI for accelerated bowel motility imaging.

BACKGROUND: To investigate the feasibility of compressed sensing and parallel imaging (CS-PI)-accelerated bowel motility magnetic resonance imaging (MRI) and to compare its image quality and diagnostic quality to conventional sensitivity encoding (SENSE) accelerated scans. METHODS: Bowel MRI was performed in six volunteers using a three-dimensional balanced fast field-echo sequence. Static scans were performed after the administration of a spasmolytic agent to prevent bowel motion artefacts. Fully sampled reference scans and multiple prospectively 3× to 7× undersampled CS-PI and SENSE scans were acquired. Additionally, fully sampled CS-PI and SENSE scans were retrospectively undersampled and reconstructed. Dynamic scans were performed using 5× to 7× accelerated scans in the presence of bowel motion. Retrospectively, undersampled scans were compared to fully sampled scans using structural similarity indices. All reconstructions were visually assessed for image quality and diagnostic quality by two radiologists. RESULTS: For static imaging, the performance of CS-PI was lower than that of fully sampled and SENSE scans: the diagnostic quality was assessed as adequate or good for 100% of fully sampled scans, 95% of SENSE, but only for 55% of CS-PI scans. For dynamic imaging, CS-PI image quality was scored similar to SENSE at high acceleration. Diagnostic quality of all scans was scored as adequate or good; 55% of CS-PI and 83% of SENSE scans were scored as good. CONCLUSION: Compared to SENSE, current implementation of CS-PI performed less or equally good in terms of image quality and diagnostic quality. CS-PI did not show advantages over SENSE for three-dimensional bowel motility imaging.

Predictive factors on CT imaging for progression of uncomplicated into complicated acute diverticulitis.

PURPOSE: Since outpatient treatment and omitting antibiotics for uncomplicated acute colonic diverticulitis have been proven to be safe in the majority of patients, selection of patients that may not be suited for this treatment strategy becomes an important topic. The aim of this study is to identify computed tomography (CT) imaging predictors for a complicated disease course of initially uncomplicated acute diverticulitis. METHODS: CT imaging from a randomized controlled trial (DIABOLO study) of an observational vs. antibiotic treatment strategy of first-episode uncomplicated acute diverticulitis patients was re-evaluated. For each patient that developed complicated diverticulitis within 90 days after randomization, two patients with an uncomplicated disease course were randomly selected. Two abdominal radiologists, blinded for outcomes, independently re-evaluated all CTs. RESULTS: Of the 528 patients in the DIABOLO trial, 16 patients developed complications (abscess > 5 cm, perforation, bowel obstruction) within 90 days after randomization. In the group with a complicated course of initially uncomplicated diverticulitis, more patients with fluid collections (25 vs. 0%; p = 0.009) and a longer inflamed colon segment (86 ± 26 mm vs. 65 ± 21 mm; p = 0.007) were observed compared to an uncomplicated course of disease. Pericolic extraluminal air was no predictive factor. CONCLUSION: Fluid collections and to a lesser extent the length of the inflamed colon segment may serve as predictive factors on initial CT for a complicated disease course in patients with uncomplicated acute colonic diverticulitis. These findings may aid in the selection of patients not suitable for outpatient treatment and treatment without antibiotics.

Nationwide outcomes in patients undergoing surgical exploration without resection for pancreatic cancer.

BACKGROUND: Despite improvements in diagnostic imaging and staging, unresectable pancreatic cancer is still encountered during surgical exploration with curative intent. This nationwide study investigated outcomes in patients with unresectable pancreatic cancer found during surgical exploration. METHODS: All patients diagnosed with primary pancreatic (adeno)carcinoma (2009-2013) in the Netherlands Cancer Registry were included. Predictors of unresectability, 30-day mortality and poor survival were evaluated using logistic and Cox proportional hazards regression analysis. RESULTS: There were 10 595 patients with pancreatic cancer during the study interval. The proportion of patients undergoing surgical exploration increased from 19·9 to 27·0 per cent (P < 0·001). Among 2356 patients who underwent surgical exploration, the proportion of patients with tumour resection increased from 61·6 per cent in 2009 to 71·3 per cent in 2013 (P < 0·001), whereas the contribution of M1 disease (18·5 per cent overall) remained stable. Patients who had exploration only had an increased 30-day mortality rate compared with those who underwent tumour resection (7·8 versus 3·8 per cent; P < 0·001). In the non-resected group, among those with M0 (383 patients) and M1 (435) disease at surgical exploration, the 30-day mortality rate was 4·7 and 10·6 per cent (P = 0·002), median survival was 7·2 and 4·4 months (P < 0·001), and 1-year survival rates were 28·0 and 12·9 per cent, respectively. Among other factors, low hospital volume (0-20 resections per year) was an independent predictor for not undergoing tumour resection, but also for 30-day mortality and poor survival among patients without tumour resection. CONCLUSION: Exploration and resection rates increased, but one-third of patients who had surgical exploration for pancreatic cancer did not undergo resection. Non-resectional surgery doubled the 30-day mortality rate compared with that in patients undergoing tumour resection.

The development of a magnetic resonance imaging index for fistulising Crohn's disease.

BACKGROUND: Magnetic resonance imaging (MRI) is the gold standard for assessment of perianal fistulising Crohn's disease (CD). The Van Assche index is the most commonly used MRI fistula index. AIMS: To assess the reliability of the Van Assche index, and to modify the instrument to improve reliability and create a novel index for fistulising CD. METHODS: A consensus process developed scoring conventions for existing Van Assche index component items and new items. Four experienced radiologists evaluated 50 MRI images in random order on three occasions. Reliability was assessed by estimates of intraclass correlation coefficients (ICCs). Common sources of disagreement were identified and recommendations made to minimise disagreement. A mixed effects model used a 100 mm visual anologue scale (VAS) for global severity as outcome and component items as predictors to create a modified Van Assche index. RESULTS: Intraclass correlation coefficients (95% confidence intervals) for intra-rater reliability of the original and modified Van Assche indices and the VAS were 0.86 (0.81-0.90), 0.90 (0.86-0.93) and 0.86 (0.82-0.89). Corresponding ICCs for inter-rater reliability were 0.66 (0.52-0.76), 0.67 (0.55-0.75) and 0.58 (0.47-0.66). Sources of disagreement included number, location, and extension of fistula tracts, and rectal wall involvement. A modified Van Assche index (range 0-24) was created that included seven component items. CONCLUSIONS: Although "almost perfect" intra-rater reliability was observed for the assessment of MRI images for fistulising CD using the Van Assche index, inter-rater reliability was considerably lower. Our modification of this index should result in a more optimal instrument.

Shortened oral contrast preparation for improved small bowel distension at MR enterography.

PURPOSE: Adequate small bowel distension in MR enterography is important for the evaluation of disease activity in Crohn's disease patients. While distension of the distal small bowel can be achieved using standard oral contrast preparation, proximal small bowel distension remains a common impediment. The aim of this study was to compare small bowel distension between a 60-min oral contrast preparation and a 45-min oral contrast preparation. METHODS: Fifty retrospectively included patients with a 60-min oral preparation protocol and 50 prospectively included patients with a 45-min three-portion oral preparation protocol were included in the study. Both groups gradually ingested a total of 1600 mL 2% Mannitol solution during the preparation time. Two observers independently graded distension of the stomach, duodenum, jejunum, ileum, and (neo-) terminal ileum. Total small bowel distension was calculated as the sum of all small bowel segment scores. Individual and averaged observer distension scores were compared between both groups of patients using χ 2 test for ordinal variables. RESULTS: Significant differences in distension for one of both observers in favor of the 45-min protocol were found for the stomach (p = 0.04), duodenum (p = 0.02), jejunum (p = 0.02), and total small bowel (p = 0.02). When distension scores were averaged between observers, the stomach, jejunum, and total small bowel showed a significant difference in favor of the 45-min protocol (p = 0.04, 0.02, and 0.02, respectively). CONCLUSION: We advise to use a 45-min three-portion oral preparation protocol for MR enterography for improved overall small bowel distension, proximal small bowel distension, and especially jejunal distension.

Skeletal Muscle Quality is Associated with Worse Survival After Pancreatoduodenectomy for Periampullary, Nonpancreatic Cancer.

BACKGROUND: Body composition measures may predict outcomes of cancer surgery. Whereas low muscle mass shown on preoperative computed tomography (CT) scans has been associated with worse outcomes after surgery for pancreatic cancer, less consideration has been given to low muscle attenuation, reflecting poor muscle quality. Studies relating muscle mass and muscle attenuation with outcomes for patients with periampullary, nonpancreatic cancer are lacking. METHODS: Skeletal muscle mass and attenuation were assessed in 166 consecutive patients undergoing pancreatoduodenectomy (PD) for periampullary, nonpancreatic cancer at a single center between 2000 and 2012. The skeletal muscle index (SMI) was calculated from cross-sectional muscle area on preoperative CT imaging at the third lumbar vertebra level (L3) and normalized for height. The skeletal muscle attenuation index (MAI) was calculated by measuring the average Hounsfield units of the total muscle area at the L3 level. Overall survival (OS) and the rate of major postoperative complications (Clavien-Dindo ≥3) were extracted from prospectively maintained databases. RESULTS: Low SMI was present in 78.3 % and low MAI in 48.8 % of the patients. The multivariate analysis showed lymph node metastasis [hazard ratio (HR) 1.8; 95 % confidence interval (CI) 1.1-2.9], microscopic radicality (HR 2.0; 95 % CI 1.2-3.4), and low MAI (HR 2.0; 95 % CI 1.2-3.3), but not low SMI to be significantly associated with decreased OS. Low MAI (HR 1.9; 95 % CI 1.0-3.8) was the only independent risk factor for major postoperative complications. CONCLUSION: Skeletal muscle quality, but not muscle mass, predicted survival and major complications after PD for periampullary, nonpancreatic cancer. Preoperative CT-derived body composition measures may stratify patients into risk categories and support shared decision making.

CT-Colonography vs. Colonoscopy for Detection of High-Risk Sessile Serrated Polyps.

OBJECTIVES: Sessile serrated polyps (SSPs) are suggested to be the precursors of 15-30% of all colorectal cancers (CRCs). Therefore, CRC screening modalities should also be designed to detect high-risk SSPs. We compared computed tomography colonography (CTC) with colonoscopy-based screening for the detection of high-risk SSPs in average-risk individuals. METHODS: Data from a randomized controlled trial that compared CTC with colonoscopy for population screening were used for the analysis. Individuals diagnosed at CTC with a lesion ≥10 mm in size were referred for colonoscopy. Individuals with only 6-9 mm lesions were offered surveillance CTC. This surveillance CTC was followed by a colonoscopy when a lesion ≥6 mm was detected. Yield of both was accumulated to mimic current American College of Radiology CTC referral strategy (referral of individuals with any lesion ≥6 mm). Per participant detection of ≥1 high-risk (dysplastic and/or ≥10 mm) SSP was compared with colonoscopy using multiple logistic regression analysis. RESULTS: In total, 8,844 individuals were invited to participate (in 2:1 allocation), of which 1,276 colonoscopy and 982 CTC invitees participated in the study. In the colonoscopy arm, 4.3% of individuals were diagnosed with ≥1 high-risk SSP, compared with 0.8% in the CTC arm (odds ratio (OR) 5.5; 95% confidence interval (CI) 2.6-11.6; P<0.001). In total, 3.1% of individuals in the colonoscopy arm were diagnosed with high-risk SSPs as most advanced lesion, compared with 0.4% in the CTC arm (OR 7.7; 95% CI 2.7-21.6; P<0.001). The current CTC strategy showed a marked lower detection for especially flat high-risk SSPs (17 vs. 0), high-risk SSP located in the proximal colon (32 vs. 1), and SSPs with dysplasia (30 vs. 1). CONCLUSIONS: In a randomized controlled setting, the detection rate of high-risk SSPs was significantly higher with colonoscopy than CTC. These results might have implications for CTC as a CRC modality for opportunistic screening in average-risk adults.

A multicentre comparative prospective blinded analysis of EUS and MRI for screening of pancreatic cancer in high-risk individuals.

OBJECTIVE: Endoscopic ultrasonography (EUS) and MRI are promising tests to detect precursors and early-stage pancreatic ductal adenocarcinoma (PDAC) in high-risk individuals (HRIs). It is unclear which screening technique is to be preferred. We aimed to compare the efficacy of EUS and MRI in their ability to detect clinically relevant lesions in HRI. DESIGN: Multicentre prospective study. The results of 139 asymptomatic HRI (>10-fold increased risk) undergoing first-time screening by EUS and MRI are described. Clinically relevant lesions were defined as solid lesions, main duct intraductal papillary mucinous neoplasms and cysts ≥10 mm. Results were compared in a blinded, independent fashion. RESULTS: Two solid lesions (mean size 9 mm) and nine cysts ≥10 mm (mean size 17 mm) were detected in nine HRI (6%). Both solid lesions were detected by EUS only and proved to be a stage I PDAC and a multifocal pancreatic intraepithelial neoplasia 2. Of the nine cysts ≥10 mm, six were detected by both imaging techniques and three were detected by MRI only. The agreement between EUS and MRI for the detection of clinically relevant lesions was 55%. Of these clinically relevant lesions detected by both techniques, there was a good agreement for location and size. CONCLUSIONS: EUS and/or MRI detected clinically relevant pancreatic lesions in 6% of HRI. Both imaging techniques were complementary rather than interchangeable: contrary to EUS, MRI was found to be very sensitive for the detection of cystic lesions of any size; MRI, however, might have some important limitations with regard to the timely detection of solid lesions.

The feasibility of colorectal cancer detection using dual-energy computed tomography with iodine mapping.

AIM: To assess the feasibility of colorectal cancer detection using dual-energy computed tomography with iodine mapping and without bowel preparation or bowel distension. MATERIALS AND METHODS: Consecutive patients scheduled for preoperative staging computed tomography (CT) because of diagnosed or high suspicion for colorectal cancer were prospectively included in the study. A single contrast-enhanced abdominal CT acquisition using dual-source mode (100 kV/140 kV) was performed without bowel preparation. Weighted average 120 kV images and iodine maps were created with post-processing. Two observers performed a blinded read for colorectal lesions after being trained on three colorectal cancer patients. One observer performed an unblinded read for lesion detectability and placed a region of interest (ROI) within each lesion. RESULTS: In total 21 patients were included and 18 had a colorectal cancer at the time of the CT acquisition. Median cancer size was 43 mm [interquartile range (IQR) 27-60 mm] and all 18 colorectal cancers were visible on the 120 kV images and iodine map during the unblinded read. During the blinded read, observers found 90% (27/30) of the cancers with 120 kV images only and 96.7% (29/30) after viewing the iodine map in addition (p = 0.5). Median enhancement of colorectal cancers was 29.9 HU (IQR 23.1-34.6). The largest benign lesions (70 and 25 mm) were visible on the 120 kV images and iodine map, whereas four smaller benign lesions (7-15 mm) were not. CONCLUSION: Colorectal cancers are visible on the contrast-enhanced dual-energy CT without bowel preparation or insufflation. Because of the patient-friendly nature of this approach, further studies should explore its use for colorectal cancer detection in frail and elderly patients.

An adrenal incidentaloma: how often is it detected and what are the consequences?

Objectives. The aim of this study was to investigate the detection rate of adrenal incidentalomas and subsequent workup. Design. Retrospective cohort study. Methods. Two investigators evaluated the adrenals on abdominal CT scans. Abnormalities were compared to the original radiology reports and an experienced abdominal radiologist reviewed the CT scans. All additional imaging and laboratory tests were assessed. Results. The investigators detected 44/356 adrenal incidentalomas (12%). In 25 patients an adrenal incidentaloma had been noted in the radiology report. The expert radiologist agreed on 19 incidentalomas in 17 patients, two with bilateral incidentalomas. Of the 25 incidentaloma patients, 4 (16%) patients were screened for hormonal overproduction and 2 (8%) patients had follow-up imaging studies. Conclusions. 12% of the patients had an adrenal incidentaloma (42 of 356). 17 (40%) had initially not been reported by the radiologist. When diagnosed with an adrenal incidentaloma, only a small percentage of patients (16%) is screened or undergoes repeated imaging (8%) as proposed in the National Institutes of Health (NIH) guidelines on adrenal incidentalomas.

Dynamic contrast-enhanced MRI in patients with luminal Crohn's disease.

OBJECTIVES: To prospectively assess dynamic contrast-enhanced (DCE-)MRI as compared to conventional sequences in patients with luminal Crohn's disease. METHODS: Patients with Crohn's disease undergoing MRI and ileocolonoscopy within 1 month had DCE-MRI (3T) during intravenous contrast injection of gadobutrol, single shot fast spin echo sequence and 3D T1-weighted spoiled gradient echo sequence, a dynamic coronal 3D T1-weighted fast spoiled gradient were performed before and after gadobutrol. Maximum enhancement (ME) and initial slope of increase (ISI) were calculated for four colon segments (ascending colon+coecum, transverse colon, descending colon+sigmoid, rectum) and (neo)terminal ileum. C-reactive protein (CRP), Crohn's disease activity index (CDAI), per patient and per segment Crohn's disease endoscopic index of severity (CDEIS) and disease duration were determined. Mean values of the (DCE-)MRI parameters in each segment from each patient were compared between four disease activity groups (normal mucosa, non-ulcerative lesions, mild ulcerative and severe ulcerative disease) with Mann-Whitney test with Bonferroni adjustment. Spearman correlation coefficients were calculated for continuous variables. RESULTS: Thirty-three patients were included (mean age 37 years; 23 females, median CDEIS 4.4). ME and ISI correlated weakly with segmental CDEIS (r=0.485 and r=0.206) and ME per patient correlated moderately with CDEIS (r=0.551). ME was significantly higher in segments with mild (0.378) or severe (0.388) ulcerative disease compared to normal mucosa (0.304) (p<0.001). No ulcerations were identified at conventional sequences. ME correlated with disease duration in diseased segments (r=0.492), not with CDAI and CRP. CONCLUSIONS: DCE-MRI can be used as a method for detecting Crohn's disease ulcerative lesions.

Imaging modalities for the staging of patients with colorectal cancer.

Dutch guidelines made the following recommendations for staging colorectal cancer (CRC). For liver metastases, computed tomography (CT) or magnetic resonance imaging (MRI) could be used. For lung metastases, imaging could be limited to chest X-ray. The primary aim of this survey was to summarise the use of imaging modalities and the variation in techniques. Three surveys were created and sent to three groups of medical specialists, namely surgeons, radiologists and nuclear medicine physicians. The management survey included questions on the role of different modalities for evaluation of synchronous liver, lung and extrahepatic metastases. The radiological survey included questions concerning the technical aspects of ultrasound (US), CT and MRI. The nuclear medicine survey included questions concerning the technical aspects of FDG-PET and FDG-PET/CT. The management and radiological surveys were sent to abdominal surgeons and abdominal radiologists within 88 hospitals and the nuclear medicine survey to specialists within 34 hospitals. Response rates were 75.0% (n=66/88), 77.3% (n=68/88) and 64.7% (n=22/34) for the management, radiological and nuclear medicine surveys, respectively. For liver metastases, the first modality of choice was CT in 52 (78.8%) and US in 12 hospitals (18.2%). Lung metastases were evaluated by either chest X-ray or chest CT and extrahepatic metastases mainly by CT (n=55). In the radiological and nuclear medicine surveys, some variations in techniques of US, CT, MRI , FDG-PET and FDG-PET/CT were seen. CT is primarily used for liver and extrahepatic metastases and both chest CT and chest X-ray for lung metastases. There are discrepancies between the survey of daily practice and the present guidelines. Comparative studies on different staging strategies for colon and rectal cancer, including comparing a strategy of CT liver/abdomen versus MRI liver/abdomen for the evaluation of liver and extrahepatic disease and chest X-ray or chest CT for lung metastases would be important for well-founded adjustments of the present guidelines.

Computed tomography-urography for upper urinary tract imaging: is it required for all patients who present with hematuria?

PURPOSE: To define in which patients who present with microscopic or macroscopic hematuria CT urography (CTU) is indicated as an imaging mode for the upper urinary tract (UUT). PATIENTS AND METHODS: We conducted a prospective study on consecutive patients who attended a modern protocol-driven hematuria clinic from January 2006 to February 2010. Standard tests (history taking, physical examination, urinalysis via dipstick method, ultrasonography of kidneys and bladder performed by urologists, cystoscopy, and cytology) were directed to all patients, whereas the mode of additional UUT imaging (ultrasonography by a radiologist or four-phase CTU/magnetic resonance (MR) urography (MRU) when CTU was contraindicated) was selected according to a risk factor-based management algorithm. The added value of cross-sectional urography (CTU/MRU) supplementary to ultrasonography (by urologists) to detect renal masses, UUT tumors, and stones was assessed. Univariate and multivariate analysis on predictive factors for cross-sectional urography result were performed. RESULTS: From the total of 841 patients, lesions that might account for hematuria could not be identified in 462 (54.9%), whereas in 250 (29.7%) and 124 (14.7%) patients, hematuria was from benign and malignant disease, respectively. Cross-sectional urography revealed relevant UUT lesions in 73 of 525 (13.9%) patients. Only result of ultrasonography (odds ratio [OR] 7.7, 95% confidence interval [CI] 4.0-14.9), P<0.001) and type of hematuria (OR 2.6, 95% CI 1.3-5.1, P=0.01) were significant predictors for cross-sectional urography result. In 44 of 456 (9.6%) patients with no abnormalities on ultrasonography, CTU/MRU revealed that these were false negatives, with most lesions missed being stones. In 253 of 309 (81.9%) patients with macroscopic hematuria, no lesions were detected in the UUT on CTU/MRU, in contrast to 199 of 216 patients (92.1%) with microscopic hematuria. CONCLUSION: For patients who present with microscopic hematuria, ultrasonography is sufficient to exclude significant UUT disease. For patients with macroscopic hematuria, the likelihood of finding UUT disease is higher, and a CTU as a first-line test seems justified.

Therapeutic delay and survival after surgery for cancer of the pancreatic head with or without preoperative biliary drainage.

OBJECTIVE: To evaluate the relation between delay in surgery because of preoperative biliary drainage (PBD) and survival in patients scheduled for surgery for pancreatic head cancer. BACKGROUND: Patients with obstructive jaundice due to pancreatic head cancer can undergo PBD. The associated delay of surgery can lead to more advanced cancer stages at surgical exploration, affecting resection rate and survival. METHODS: We conducted a multicenter, randomized controlled clinical trial to compare PBD with early surgery (ES) for pancreatic head cancer for complications. We obtained Kaplan-Meier estimates of overall survival for patients with pathology-proven malignancy and compared survival functions of ES and PBD groups using log-rank test statistics. Multivariable Cox regression analyses were performed to evaluate the prognostic role of time to surgery for overall survival. RESULTS: Mean times from randomization to surgery were 1.2 (0.9-1.5) and 5.1 (4.8-5.5) weeks in the ES and PBD groups, respectively (P < 0.001). In the ES group, 60 (67%) of 89 patients underwent resection, versus 53 (58%) of 91 patients in the PBD group (P = 0.20). Median survival after randomization was 12.2 (9.1-15.4) months in the ES group versus 12.7 (8.9-16.6) months in the PBD group (P = 0.91). A longer time to surgery was significantly associated with slightly lower mortality rate after surgery (hazard ratio = 0.90, 95% CI, 0.83-0.97), when taking into account resection, bilirubin, complications, pancreatic adenocarcinoma, tumor-positive lymph nodes, and microscopically residual disease. CONCLUSIONS: In patients with pancreatic head cancer, the delay in surgery associated with PBD does not impair or benefit survival rate.

Protrusion method for automated estimation of polyp size on CT colonography.

OBJECTIVE: The purpose of this study was to assess the accuracy and measurement variability of automated lesion measurement on CT colonography in comparison with manual 2D and 3D techniques under varying scanning conditions. MATERIALS AND METHODS: The study included phantoms (23 phantom objects) and patients (16 polyps). Measurement with sliding calipers served as the reference for the phantom data. The mean of two independent colonoscopic measurements was the reference for the polyps. The automated measurement was developed for a computer-aided detection scheme, and the size of any detected object was obtained from measurement of its largest diameter. The automated measurement was compared with manual 2D and 3D measurements by two experienced observers. RESULTS: For phantom data, the measurement variability of the automated method was significantly less than that of the two observers (p < 0.05), except for the 3D measurement by observer 1, as follows: automated, 0.86 mm; observer 1, 1.76 mm (2D), 0.96 (3D); observer 2, 1.34 mm (2D), 1.45 mm (3D). The variability of the automated method did not differ significantly from that of manual methods in measurement with patient data. The automated method had a systematic error for phantom data (1.9 mm). CONCLUSION: For phantoms, the automated method has less measurement variability than manual 2D and 3D techniques. For true polyps, the measurement variability of the automated method is comparable with that of manual methods. The automated method does not suffer from intraobserver variability. Because systematic error can be calibrated, automated size measurement may contribute to a practical evaluation strategy.

Perceptive errors in CT colonography.

Published results to date have indicated a good per patient sensitivity of computed tomographic colonography (CTC) for colorectal cancer and for polyps measuring 10 mm or more together with a very good specificity. Sensitivity and specificity for polyps in the range of 6-10 mm are moderate. These results, however, can be achieved only with meticulous attention to technique including adequate colonic distention, and acquisition of supine and prone thin-section computed tomographic (CT) images. Moreover, there is a significant learning curve involved in the interpretation of CTC studies, with performance statistics improving with operator experience. Radiologists must be comfortable in reporting directly from workstation monitors and have access to and be familiar with software for multiplanar and endoluminal reconstructions. In addition to maximize polyp detection and minimize false positive results, reporting radiologists must have a working knowledge of normal colorectal anatomy and pathology on CTC and be familiar with potential pitfalls in interpretation. Besides the description of several possible causes for perceptive errors, also a literature search of perceptive errors in CTC is included in this paper.

Reflux esophagitis.

The various therapeutic approaches for reflux esophagitis are to increase the competence of the antireflux barrier, to enhance esophageal clearance, to improve gastric emptying and pyloric sphincter competence, to coat damaged tissue, and, especially, to reduce the volume and pH of gastric contents. Of the prokinetic agents, cisapride is the only drug with proven benefit. Single-agent therapy with conventional-dose H2-receptor antagonists or sucralfate results in similar degrees of symptom relief and healing. Post-evening meal (PEM) dosing of H2-receptor antagonists appears to be a rational method of suppressing late evening gastric acidity, but on balance the symptomatic response of twice daily dosing is superior to once daily dosing. More rapid symptom relief and healing are achieved with high-dose H2-receptor antagonists and omeprazole. The significance of sustained a(hypo)chlorhydria remains to be established. To prolong the symptomatic and/or endoscopic remission, the therapy has to be continued long-term with high-dose H2-receptor antagonist, cisapride either alone or in combination with H2-receptor antagonist, or sucralfate with or without H2-receptor antagonist. In the elderly or complicated patient long-term omeprazole may be a justified alternative.