Ouzreiah Nawawi

The importance of Good Clinical Practice guidelines and its role in clinical trials.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

Benefits of 3D Rotational DSA Compared with 2D DSA in the Evaluation of Intracranial Aneurysm

RATIONALE AND OBJECTIVES The aim of this study was to compare conventional two-dimensional (2D) digital subtraction angiography (DSA) with three-dimensional (3D) rotational DSA in the investigation of intracranial aneurysm in terms of detection, size measurement, neck diameter, neck delineation, and relationship with surrounding vessels. A further aim was to compare radiation dose, contrast volume, and procedural time between the two protocols. MATERIALS AND METHODS Thirty-five patients who presented with subarachnoid bleeds on computed tomography and were suspected of having intracranial aneurysms underwent conventional 2D DSA followed by 3D DSA. The 3D digital subtraction angiographic images were displayed as surface shaded display images. Aneurysm detection, sac size, neck diameter, neck delineation, and relationship of aneurysm to the surrounding vessels analyzed from the two protocols were compared. Radiation dose, contrast volume, and procedural time for both examinations were also compared. RESULTS Three-dimensional DSA detected 44 aneurysms in 31 patients, with negative findings seen in four patients. A false-negative detection rate of 6.8% (three of 44) for 2D DSA was noted. There was no significant difference in aneurysm size between 3D and 2D DSA. The sizes of aneurysm necks were found to be significantly larger in 3D DSA than on 2D DSA. The aneurysm neck and relationship to surrounding vessels were significantly better demonstrated on 3D DSA than on 2D DSA. Radiation dose (entrance surface dose), contrast use, and procedural time with 3D DSA were significantly less than with 2D DSA. CONCLUSIONS Three-dimensional DSA improves the detection and delineation of intracranial aneurysms, with lower radiation dose, less contrast use, and shorter procedural time compared to 2D DSA. The size of the aneurysm neck on 3D DSA tended to be larger than on 2D DSA.

Phytobezoar: an unusual cause of intestinal obstruction.

Small bowel phytobezoars are rare and almost always obstructive. There have been previously reported cases of phytobezoars in the literature, however there are few reports on radiological findings for small bowel bezoars. Barium studies characteristically show an intraluminal filling defect of variable size that is not fixed to the bowel wall with barium filling the interstices giving a mottled appearance. On CT scan, the presence of a round or ovoid intraluminal mass with a ‘mottled gas’ pattern is believed to be pathognomonic. Since features on CT scans are characteristics and physical findings are of little assistance in the diagnosis of bezoar, the diagnostic value of CT needs to be emphasised.

Transarterial embolisation of hepatocellular carcinoma with doxorubicin-eluting beads: single centre early experience

Purpose: This is a retrospective study to evaluate the results of our early experience of using doxorubicin eluting beads (DEB) to treat patients with early and intermediate hepatocellular carcinoma (HCC). Material and methods: A cohort of 19 patients (84.2% male; 15.8% female; mean age 59.2 years ± 11.0; range, 32-80 years) with documented HCC of size 1.8-10cm (mean, 4.0cm ± 1.8 ) undergoing DEB transarterial chembolisation (TACE) was reviewed. All patients had at least one image examination (multiphase computed tomography or magnetic resonance imaging) after embolisation. Results: A total of 32 procedures were performed. The objective response according to the European Association for the Study of the Liver criteria was 57.9% at 1-month, 42.8% at 6-month and 50.0% at 1-year follow up. There were 4 (21.1%) treatment-related complications (1 liver abscess, 2 pancreatitis and 1 tumour rupture) which resulted in 2 deaths. One death occurred 3 weeks after second embolisation, due to ruptured pancreatic pseudocyst, giving a 5.3% 30-day mortality rate. Another patient died 2 months after embolisation caused by tumour rupture. Eight patients received radiofrequency ablation after embolisation for residual or recurrent tumours. The 1-year survival rate in the DEB TACE only group was 80% while the 1- and 2-year survival rate in the group that received radiofrequency after DEB TACE was 85.7% and 100% respectively. Conclusion: DEB TACE is safe and effective in select group of patients. Survival may be improved when combined with other treatment modality.

A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases

This study aims to determine the most efficacious dose of Botulinum neurotoxin type A (BoNT-A) in reducing sialorrhea in Asian adults with neurological diseases. A prospective, double-blind randomized controlled trial was conducted over 24 weeks. Thirty patients with significant sialorrhea were randomly assigned to receive a BoNT-A (Dysport®) injection into the submandibular and the parotid glands bilaterally via an ultrasound guidance. The total dose given per patient was either BoNT-A injection of (i) 50 U; (ii) 100 U; or (iii) 200 U. The primary outcome was the amount of saliva reduction, measured by the differential weight (wet versus dry) of intraoral dental gauze at baseline and at 2, 6, 12, and 24 weeks after injection. The secondary outcome was the subjective report of drooling using the Drooling Frequency and Severity Scale (DFS). Saliva reduction was observed in response to all BoNT-A doses in 17 patients who completed the assessments. Although no statistically significant difference among the doses was found, the measured reduction was greater in groups that received higher doses (100 U and 200 U). The group receiving 200 U of Dysport® showed the greatest reduction of saliva until 24 weeks and reported the most significant improvement in the DFS score.

A Rare Case of Primary Infiltrating Neuroendocrine Carcinoma of the Breast

Primary neuroendocrine carcinoma of the breast is a very rare malignant tumor. There are not many cases reported in the English literature since it was first documented in 1983. Reports on the imaging features, in particular the ultrasonographic features of this rare tumor are scarce. Herein, we report a case of aggressive primary infiltrating neuroendocrine carcinoma of the breast, masquerading as an inflammatory breast condition in a 22-year-old young lady, perhaps the youngest case ever reported in the English literature. We discuss the imaging features and highlight the Doppler ultrasonographic findings of this rare breast carcinoma. This is the first documentation on Doppler ultrasonographic findings of primary neuroendocrine carcinoma of the breast in the literature.

Jaundice and life‐threatening hemobilia: An uncommon presentation of choledochal cyst

Hemobilia with jaundice as a result of cholestasis and bleeding from choledochal cyst is uncommon. Ascertaining the diagnosis is often challenging and delayed diagnosis can lead to significant consequences due to hemodynamic instability, particularly in elderly patients. Although surgery remains the definitive treatment modality, interventional radiology for hemostasis has been increasingly recognized as an option. In this manuscript, we described two Malaysian cases of jaundice and hemobilia associated with choledochal cysts and the challenges related with clinical diagnosis and management.