Clinical Research Directory

International Delphi Study to Develop Standardized Quality Criteria and a Rating Tool for Liver CEUS Image Quality Assessment

This study aims to establish international consensus-based quality criteria for contrast-enhanced ultrasound (CEUS) examinations of the liver and to develop a standardized tool for assessing CEUS image quality. CEUS is an established imaging technique used in clinical practice for the characterization and assessment of focal liver lesions and other liver abnormalities. Despite its increasing use, there are currently no universally accepted or validated standards for evaluating the quality and reproducibility of CEUS examinations. The primary objective of this project is therefore to identify robust and clinically relevant quality indicators for liver CEUS examinations through an international Delphi consensus process. The study focuses specifically on CEUS examinations performed in adult patients using the ultrasound contrast agent SonoVue®. The project is divided into two work packages (WP). In Work Package 1 (WP1), the study team will first conduct a structured review of the available literature and discuss potential CEUS quality criteria within the research group. Based on this process, an initial catalogue of quality indicators relating to technical, procedural, and imaging characteristics relevant to liver CEUS examinations will be developed. These proposed criteria will subsequently be evaluated through a multi-round Delphi process involving an international and interdisciplinary panel of experienced CEUS users and experts. A minimum of 20 panellists will participate across all Delphi rounds. Participants will rate their level of agreement with each proposed quality criterion using a 7-point Likert scale and may suggest additional criteria where appropriate. Newly proposed criteria supported by more than 10% of participants will be included in subsequent Delphi rounds. During each round, panellists will receive anonymised feedback summarising the responses of the group and will be invited to re-evaluate the relevance of the proposed criteria. This iterative process will continue for at least three rounds or until predefined consensus criteria are achieved. Consensus will be defined as at least 70% agreement with a rating of 6 or higher on the Likert scale. In Work Package 2 (WP2), the consensus-based quality criteria identified in WP1 will be operationalised into a comprehensive and standardized rating scale for CEUS image quality assessment. Individual criteria will be grouped into broader domains and transformed into practical assessment items and prompts. The resulting rating tool will then be circulated among all Delphi panel members for final review and feedback to ensure clarity, applicability, and international usability. The overall goal of this study is to improve standardization, quality assurance, and reproducibility in liver CEUS examinations. The developed consensus criteria and rating scale may support clinical practice, future research studies, multicentre collaborations, and educational initiatives by enabling more consistent evaluation of CEUS image quality across institutions and countries.

Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting

Every year, many patients undergo weight-loss (bariatric) surgery. While this surgery leads to significant and intended weight loss, it also increases the risk of developing gallstones or other gallbladder problems. Approximately one in five patients later requires a second operation to remove the gallbladder. This type of surgery carries a higher risk of complications and reoperations compared with gallbladder surgery performed in the general population. Preventive treatment may help reduce this risk. One option is medical treatment with Ursochol, which has been shown to lower the risk of developing gallstones after bariatric surgery. However, this treatment is only effective in patients who have not already developed gallstones before surgery. This means patients need a reliable preoperative ultrasound examination of the gallbladder. Unfortunately, performing ultrasound can be technically challenging in patients with obesity, making it harder to detect small stones or other abnormalities. The goal is therefore to improve the examination of the gallbladder in patients undergoing bariatric surgery in order to better identify who may benefit from preventive treatment. The study The investigators are comparing two types of ultrasound examination of the gallbladder: * Standard ultrasound performed on the outside of the abdomen using a handheld probe. * Laparoscopic ultrasound performed during bariatric surgery using a small ultrasound probe placed inside the abdomen, typically placed on the liver near the gallbladder. It is of interest to find out whether the ultrasound performed during surgery finds more: * Gallstones * Sludge * Small stones (microlithiasis) * Thickening of the gallbladder wall By improving detection, the investigators aim to better guide preventive treatment and reduce the need for future gallbladder surgery.

Feasibility and Preliminary Effects of a Structured Resistance Training Program in Children Aged 10-14 Years

This study is a randomised controlled pilot trial designed to evaluate the feasibility, safety, and preliminary efficacy of a 12-week resistance training intervention in children aged 10-14 years. The study adheres to the CONSORT extension for randomised pilot and feasibility trials and incorporates key elements of the SPIRIT guidelines for clinical trial protocols. The primary purpose of the study is to assess feasibility-related outcomes and to generate effect size estimates to inform the design of a subsequent fully powered randomised controlled trial (RCT).