A randomized double-blind placebo-controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT colonography

<p>Abstract</p> <p>Background</p> <p>Although CT colonography is a less invasive alternative for colonoscopy for the detection of colorectal polyps and cancer, procedural pain is common. In several studies, CT colonography pain and burden is higher than in colonoscopy. Apart from discomfort, anxiety and its related stress-induced peri- procedural side effects, this may influence the adherence for CT colonography as a possible screening tool for colorectal cancer. We hypothesize that a single bolus intravenous alfentanil will give a clinically relevant reduction in maximum pain defined as at least 1.3 point reduction on an 11-point numeric rating scale (NRS).</p> <p>Methods/Design</p> <p>A randomized double-blind placebo-controlled trial in which patients scheduled for elective CT colonography in a single tertiary centre are eligible for inclusion. The first 90 consenting patient will be block-randomized to either the alfentanil group or the placebo group. Before bowel insufflation, the alfentanil group receives a single bolus intravenous alfentanil 7.5 μg/kg dissolved in 0.9% NaCl, while the placebo group receives an intravenous bolus injection of pure 0.9% NaCl. For both groups an equal amount of fluid per kilogram (75 μL/kg) is injected. The primary outcome is the difference in maximum pain on an 11-point NRS. Secondary outcomes include: pain and burden of different CT colonography aspects, side effects, procedural time and recovery time. For the primary outcome an independent samples t-test is performed and a P value < 0.05 is considered statistically significant.</p> <p>Discussion</p> <p>This study will provide evidence whether a single bolus intravenous alfentanil gives a clinically relevant reduction in maximum pain during CT colonography.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= NTR2902">NTR2902</a></p> <p><it>This trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The department of radiology of the Academic Medical Center of Amsterdam is responsible for the design and conduct of the trial</it>.</p

Current Status of Magnetic Resonance Colonography for Screening and Diagnosis of Colorectal Cancer

Magnetic resonance colonography with its high tissue contrast and without the use of ionizing radiation was designed as a minimally invasive screening tool for colorectal cancer and its precursors. Nonetheless, heterogeneous data on diagnostic performance and patient burden have hindered its use in screening. This article provides an overview on the status and potential of magnetic resonance colonography in the setting of detection and screening of colorectal cancer and its precursors

Patients Who Undergo Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Restaged by Using Diagnostic MR Imaging: A Systematic Review and Meta-Analysis

To obtain performance values of magnetic resonance (MR) imaging for restaging locally advanced rectal cancer after neoadjuvant treatment regarding tumor staging, nodal staging, and tumor-free circumferential resection margins (CRMs). MEDLINE, EMBASE, and Cochrane databases were searched for studies regarding restaging compared with a reference standard by using the terms rectal neoplasms, MR imaging, and chemotherapy. The Quality Assessment of Diagnostic Accuracy Studies tool was used, and data on imaging criteria, histopathologic criteria, and restaging were extracted. Responders were defined as positives and nonresponders, as negatives. Mean sensitivity, mean specificity, and positive and negative likelihood ratios (LRs) were determined by using a bivariate random-effects model. A positive LR greater than 5 implied moderate results for responders. Thirty-three studies evaluated 1556 patients. For tumor stage, mean sensitivity was 50.4%, mean specificity was 91.2%, positive LR was 5.76, and negative LR was 0.54. Diffusion-weighted (DW) imaging showed comparable positive LR with significantly improved sensitivity (P = .01) and negative LR (P = .04). Experienced observers showed higher sensitivity (P = .01) and lower negative LR (P = .03) compared with less experienced observers. For CRM, mean sensitivity, mean specificity, positive LR, and negative LR were 76.3%, 85.9%, 5.40, and 0.28, respectively. For nodal stage per patient, mean sensitivity, mean specificity, positive LR, and negative LR were 76.5%, 59.8%, 1.90, and 0.39, respectively; and for nodal stage on a lesion basis, these values were 90.7%, 73.0%, 3.37, and 0.13, respectively. MR imaging showed heterogeneous results of diagnostic performances for restaging rectal cancer after neoadjuvant treatment, but significantly better results were demonstrated when DW imaging was used or with experienced observers. MR imaging can also be used for evaluation of CRM staging, but nodal staging remains challengin

Use of continuously MR tagged imaging for automated motion assessment in the abdomen: A feasibility study

Purpose: To investigate the feasibility of measuring motion in the abdomen using a continuously tagged magnetic resonance imaging sequence. Materials and Methods: To assess (nonperiodic) motion in the abdomen, a nontriggered, continuously tagged transient field echo (TFE) sequence was implemented that acquires one complete 3D dataset per prepulse after a fixed delay. In postprocessing, a frequency analysis approach was developed for compact reviewing of the data and noise suppression. For proof of principle, a simulation was made and one free-breathing dynamic in vivo scan was acquired in a healthy volunteer. During the dynamic scan the volunteer received glucagon intravenously. Results: The simulation showed that this frequency analysis enables the extraction of motion at low signal-to-noise ratio levels. Motion information was successfully gathered from the in vivo scan. The decline in bowel motion caused by the administration of glucagon could be quantitatively measured using the continuously tagged sequence. Conclusion: Continuously tagged imaging in the abdomen for the purpose of automated gathering of motion information is feasible and could aid the study of bowel motion. J. Magn. Reson. Imaging 2012;36:492497. (c) 2012 Wiley Periodicals, In

Electronic cleansing for 24-h limited bowel preparation CT colonography using principal curvature flow

CT colonography (CTC) is one of the recommended methods for colorectal cancer screening. The subject's preparation is one of the most burdensome aspects of CTC with a cathartic bowel preparation. Tagging of the bowel content with an oral contrast medium facilitates CTC with limited bowel preparation. Unfortunately, such preparations adversely affect the 3-D image quality. Thus far, data acquired after very limited bowel preparation were evaluated with a 2-D reading strategy only. Existing cleansing algorithms do not work sufficiently well to allow a primary 3-D reading strategy. We developed an electronic cleansing algorithm, aimed to realize optimal 3-D image quality for low-dose CTC with 24-h limited bowel preparation. The method employs a principal curvature flow algorithm to remove heterogeneities within poorly tagged fecal residue. In addition, a pattern recognition-based approach is used to prevent polyp-like protrusions on the colon surface from being removed by the method. Two experts independently evaluated 40 CTC cases by means of a primary 2-D approach without involvement of electronic cleansing as well as by a primary 3-D method after electronic cleansing. The data contained four variations of 24-h limited bowel preparation and was based on a low radiation dose scanning protocol. The sensitivity for lesions ≥ 6 mm was significantly higher for the primary 3-D reading strategy (84%) than for the primary 2-D reading strategy (68%) (p = 0.031). The reading time was increased from 5:39 min (2-D) to 7:09 min (3-D) (p = 0.005); the readers' confidence was reduced from 2.3 (2-D) to 2.1 (3-D) ( p = 0.013) on a three-point Likert scale. Polyp conspicuity for cleansed submerged lesions was similar to not submerged lesions (p = 0.06). To our knowledge, this study is the first to describe and clinically validate an electronic cleansing algorithm that facilitates low-dose CTC with 24-h limited bowel preparatio

Evaluation of a Standardized CT Colonography Training Program for Novice Readers

Purpose: To determine how many computed tomographic (CT) colonography training studies have to be evaluated by novice readers to obtain an adequate level of competence in polyp detection. Materials and Methods: The study was approved by the Institutional Review Board. Informed consent was obtained from all participants. Six physicians (one radiologist, three radiology residents, two researchers) and three technicians completed a CT colonography training program. Two hundred CT colonographic examinations with colonoscopic verification were selected from a research database, with 100 CT colonographic examinations with at least one polyp 6 mm or larger. After a lecture session and short individual hands-on training, CT colonography training was done individually with immediate feedback of colonoscopy outcome. Per-polyp sensitivity was calculated for four sets of 50 CT colonographic examinations for lesions 6 mm or larger. By using logistic regression analyses, the number of CT colonographic examinations to reach 90% sensitivity for lesions 6 mm or larger was estimated. Reading times were registered. Results: The average per-polyp sensitivity for lesions 6 mm or larger was 76% (207 of 270) in the first set of 50 CT colonographic examinations, 77% (262 of 342) in the second (P = .96 vs first set), 80% (310 of 387) in the third (P = .67 vs first set), and 91% (261 of 288) in the fourth (P = .018). The estimated number of CT colonographic examinations for a sufficient sensitivity was 164. Six of nine readers reached this level of competence within 175 CT colonographic examinations. Reading times decreased significantly from the first to the second set of 50 CT colonographic examinations for six readers. Conclusion: Novice CT colonography readers obtained sensitivity equal to that of experienced readers after practicing on average 164 CT colonographic studies. (C)RSNA, 201