scholarly journals Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique in the management of unresectable malignant biliary obstruction: study protocol for a prospective, multicentre, randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ye Liao ◽  
Marc Giovannini ◽  
Ning Zhong ◽  
Tingyue Xiao ◽  
Shiyun Sheng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Endoscopic Ultrasound ◽  
Biliary Obstruction ◽  
Cox Regression ◽  
Controlled Trial ◽  
Malignant Biliary Obstruction ◽  
Complication Rates ◽  
Ultrasound Guided ◽  
Cox Regression Analysis ◽  
Randomised Controlled

Abstract Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are preferred in patients with dilated IH bile ducts. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are appropriate for patients with unreachable papillae. Nevertheless, there have been no direct comparisons between these two approaches. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods This is a prospective, randomised, controlled, multicentre study with two parallel groups without masking. One hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of malignant biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is efficiency, described by technical and clinical success rates of EUS-HGS and EUS-AG in patients with unreachable papillae. The secondary endpoints include stent patency, overall survival rates, complication rates, length of hospital stays, and hospitalisation expenses. The chi-square test, Kaplan–Meier methods, log-rank test, and Cox regression analysis will be used to analyse the data. Discussion To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomised, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900020737. Registered on 15 January 2019

scholarly journals Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique: study protocol for a prospective, multicentre, randomised controlled trial

2019 ◽  
Author(s):  
Ye Liao ◽  
Tingyue Xiao ◽  
Shiyun Sheng ◽  
Yufan Wu ◽  
Jingjing Zhang ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Cox Regression ◽  
Controlled Trial ◽  
Rank Test ◽  
Ultrasound Guided ◽  
Clinical Trial Registry ◽  
Chi Square ◽  
Cox Regression Analysis ◽  
Chi Square Test ◽  
Randomised Controlled

Abstract Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are suggested to be preferred in patients with a dilated IH bile duct. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are available IH approaches for patients with an unreachable papilla. However, a direct comparison between these two approaches is lacking. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods: This is a prospective, randomised, controlled, multicentre study. One-hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is to compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. The secondary endpoint is the overall survival rate of patients undergoing EUS-HGS and EUS-AG. The chi-square test, Kaplan-Meier methods, the log-rank test, and Cox regression analysis will be used to analyse the data. Discussion: To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomized, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900020737; registered on 15 January 2019. http://www.chictr.org.cn/showproj.aspx?proj=33672

scholarly journals Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044219
Author(s):  
J X Harmeling ◽  
Kevin Peter Cinca ◽  
Eleni-Rosalina Andrinopoulou ◽  
Eveline M L Corten ◽  
M A Mureau
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Capsular Contracture ◽  
Tissue Expander ◽  
Complication Rates ◽  
Two Stage ◽  
Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

scholarly journals Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017379 ◽  
Author(s):  
Laurent Malisoux ◽  
Nicolas Delattre ◽  
Axel Urhausen ◽  
Daniel Theisen
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Injury Prevention ◽  
Body Mass ◽  
Injury Risk ◽  
Cox Regression ◽  
Controlled Trial ◽  
Study Groups ◽  
Self Report ◽  
Randomised Controlled

IntroductionRepetitive loading of the musculoskeletal system is suggested to be involved in the underlying mechanism of the majority of running-related injuries (RRIs). Accordingly, heavier runners are assumed to be at a higher risk of RRI. The cushioning system of modern running shoes is expected to protect runners again high impact forces, and therefore, RRI. However, the role of shoe cushioning in injury prevention remains unclear. The main aim of this study is to investigate the influence of shoe cushioning and body mass on RRI risk, while exploring simultaneously the association between running technique and RRI risk.Methods and analysisThis double-blinded randomised controlled trial will involve about 800 healthy leisure-time runners. They will randomly receive one of two running shoe models that will differ in their cushioning properties (ie, stiffness) by ~35%. The participants will perform a running test on an instrumented treadmill at their preferred running speed at baseline. Then they will be followed up prospectively over a 6-month period, during which they will self-report all their sports activities as well as any injury in an internet-based database TIPPS (Training and Injury Prevention Platform for Sports). Cox regression analyses will be used to compare injury risk between the study groups and to investigate the association among training, biomechanical and anatomical risk factors, and injury risk.Ethics and disseminationThe study was approved by the National Ethics Committee for Research (Ref: 201701/02 v1.1). Outcomes will be disseminated through publications in peer-reviewed journals, presentations at international conferences, as well as articles in popular magazines and on specialised websites.Trial registration numberNCT03115437, Pre-results.

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