-
International Journal of Surgery... Jun 2022Hepatocellular carcinoma (HCC) is subject to different management approaches and guidelines according to Eastern and Western therapeutic algorithms. Use of selective...
BACKGROUND
Hepatocellular carcinoma (HCC) is subject to different management approaches and guidelines according to Eastern and Western therapeutic algorithms. Use of selective internal radiation therapy (SIRT) with resin yttrium 90 microspheres for HCC has increased in Asia in recent years, without clearly defined indications for its optimal application. The objective of this systematic review and expert consensus statement is to provide guidance and perspectives on the use of SIRT among patients with HCC in Asia.
MATERIALS AND METHODS
A systematic literature review identified current publications on HCC management and SIRT recommendations. A group of 10 experts, representing stakeholder specialties and countries, convened between August 2020 and March 2021 and implemented a modified Delphi consensus approach to develop guidelines and indications for use of SIRT for HCC in Asia. Final recommendations were organized and adjudicated based on the level of evidence and strength of recommendation, per approaches outlined by the American College of Cardiology/American Heart Association and Oxford Centre for Evidence-Based Medicine.
RESULTS
The experts acknowledged a general lack of evidence relating to use of SIRT in Asia and identified as an unmet need the lack of phase 3 randomized trials comparing clinical outcomes and survival following SIRT versus other therapies for HCC. Through an iterative process, the expert group explored areas of clinical relevance and generated 31 guidance statements and a patient management algorithm that achieved consensus.
CONCLUSION
These recommendations aim to support clinicians in their decision-making and to help them identify and treat patients with HCC using SIRT in Asia. The recommendations also highlight areas in which further clinical trials are needed to define the role of SIRT in management of HCC among Asian populations.
Topics: Humans; Brachytherapy; Carcinoma, Hepatocellular; Liver Neoplasms; Microspheres; Yttrium Radioisotopes
PubMed: 35662438
DOI: 10.1016/j.ijsu.2021.106094 -
Clinics and Research in Hepatology and... Feb 2017Transcatheter arterial chemoembolization (TACE) is the first-line treatment for unresectable hepatocellular carcinoma (HCC). It consists of conventional TACE (cTACE) and... (Meta-Analysis)
Meta-Analysis Review
Evaluation of drug-eluting beads versus conventional transcatheter arterial chemoembolization in patients with unresectable hepatocellular carcinoma: A systematic review and meta-analysis.
BACKGROUND AND OBJECTIVES
Transcatheter arterial chemoembolization (TACE) is the first-line treatment for unresectable hepatocellular carcinoma (HCC). It consists of conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE). The comparative outcomes of the two methods remain controversial. The study aim to research the optimal TACE strategy for unresectable HCC.
METHODS
A systematic search of keywords, including 'HCC' and 'drug-eluting beads' was performed including four electronic databases: PubMed, Embase, China Biological Medicine Database (CBM), and Cochrane library databases from the date of inception to December 25, 2015. Review Manager 5.3 was used to calculate the pooled relative risks (RRs) and 95% confident intervals (CIs).
RESULTS
Sixteen cohort studies (4 RCTs, 3 prospective cohorts, 9 retrospective cohorts) were included comprising a total of 1832 patients: 822 patients with DEB-TACE therapy and 1010 patients undergoing cTACE. The 1-, 2-, and 3-year overall survival (OS) rates and 1- and 2-year relapse-free survival (RFS) rates were significantly higher in DEB-TACE group, with pooled RRs of 1.12 (95% CI=1.03-1.23, P=0.007), 1.26 (95% CI=1.03-1.54, P=0.02), 1.69 (95% CI=1.00-2.84, P=0.04), 1.21 (95% CI=1.01-1.44, P=0.03) and 1.68 (95% CI=1.17-2.43, P=0.005). There was no statistical significance in 3-year RFS, tumor response and treatment-related adverse events.
CONCLUSION
Compared with cTACE, DEB-TACE therapy significantly improved 1-, 2-, and 3-year OS rates and the 1- and 2-year RFS rates.
Topics: Carcinoma, Hepatocellular; Catheters; Chemoembolization, Therapeutic; Drug Delivery Systems; Humans; Liver Neoplasms; Microspheres; Research Design; Treatment Outcome
PubMed: 27350573
DOI: 10.1016/j.clinre.2016.05.013 -
The Cochrane Database of Systematic... Nov 2016Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is taken, and the dose needs to be adjusted according to the food consumed. A systematic review on the efficacy and safety of pancreatic enzyme replacement therapy is needed to guide clinical practice, as there is variability between centres with respect to assessment of pancreatic function, time of commencing treatment, dose and choice of supplements. This is an updated version of a published review.
OBJECTIVES
To evaluate the efficacy and safety of pancreatic enzyme replacement therapy in children and adults with cystic fibrosis and to compare the efficacy and safety of different formulations of this therapy and their appropriateness in different age groups. Also, to compare the effects of pancreatic enzyme replacement therapy in cystic fibrosis according to different diagnostic subgroups (e.g. different ages at introduction of therapy and different categories of pancreatic function).
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 15 July 2016.We also searched an ongoing trials website and the websites of the pharmaceutical companies who manufacture pancreatic enzyme replacements for any additional trials. Most recent search: 22 July 2016.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials in people of any age, with cystic fibrosis and receiving pancreatic enzyme replacement therapy, at any dosage and in any formulation, for a period of not less than four weeks, compared to placebo or other pancreatic enzyme replacement therapy preparations.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trials and extracted outcome data. They also assessed the risk of bias of the trials included in the review.
MAIN RESULTS
One parallel trial and 12 cross-over trials of children and adults with cystic fibrosis were included in the review. The number of participants in each trial varied between 14 and 129 with a total of 512 participants included in the review. All the included trials were for a duration of four weeks. The included trials had mostly an unclear risk of bias from the randomisation process as the details of this were not given; they also mostly had a high risk of attrition bias and reporting bias.We could not combine data from all the trials as they compared different formulations. Findings from individual studies provided insufficient evidence to determine the size and precision of the effects of different formulations. Ten studies reported information on the review's primary outcome (nutritional status); however, we were only able to combine data from two small cross-over studies (n = 41). The estimated gain in body weight was imprecise, 0.32 kg (95% confidence interval -0.03 to 0.67; P = 0.07). Combined data from the same studies gave statistically significant results favouring enteric-coated microspheres over enteric-coated tablets for our secondary outcomes stool frequency, mean difference -0.58 (95% confidence interval -0.85 to -0.30; P < 0.0001); proportion of days with abdominal pain, mean difference -7.96% (95% confidence interval -12.97 to -2.94; P = 0.002); and fecal fat excretion, mean difference -11.79 g (95% confidence interval -17.42 to -6.15; P < 0.0001). Data from another single small cross-over study also favoured enteric-coated microspheres over non-enteric-coated tablets with adjuvant cimetidine in terms of stool frequency, mean difference -0.70 (95% confidence interval -0.90 to -0.50; P < 0.00001).
AUTHORS' CONCLUSIONS
There is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month. In the only comparison where we could combine any data, the fact that these were cross-over studies is likely to underestimate the level of inconsistency between the results of the studies due to over-inflation of confidence intervals from the individual studies.There is no evidence on the long-term effectiveness and risks associated with pancreatic enzyme replacement therapy. There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency, optimum time to start treatment and variations based on differences in meals and meal sizes. There is a need for a properly designed study that can answer these questions.
Topics: Adult; Age Factors; Capsules; Child; Cystic Fibrosis; Delayed-Action Preparations; Enzyme Replacement Therapy; Humans; Microspheres; Nutritional Status; Pancreas; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 27878805
DOI: 10.1002/14651858.CD008227.pub3 -
The Cochrane Database of Systematic... Oct 2014Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is taken, and the dose needs to be adjusted according to the food consumed. A systematic review on the efficacy and safety of pancreatic enzyme replacement therapy is needed to guide clinical practice, as there is variability between centres with respect to assessment of pancreatic function, time of commencing treatment, dose and choice of supplements.
OBJECTIVES
To evaluate the efficacy and safety of pancreatic enzyme replacement therapy in children and adults with cystic fibrosis and to compare the efficacy and safety of different formulations of this therapy and their appropriateness in different age groups. Also, to compare the effects of pancreatic enzyme replacement therapy in cystic fibrosis according to different diagnostic subgroups (e.g. different ages at introduction of therapy and different categories of pancreatic function).
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 14 August 2014.We also searched an ongoing trials website and the websites of the pharmaceutical companies who manufacture pancreatic enzyme replacements for any additional trials. Most recent search: 12 May 2014.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials in people of any age, with cystic fibrosis and receiving pancreatic enzyme replacement therapy, at any dosage and in any formulation, for a period of not less than four weeks, compared to placebo or other pancreatic enzyme replacement therapy preparations.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trials and extracted outcome data. They also assessed the risk of bias of the trials included in the review.
MAIN RESULTS
One parallel trial and 11 cross-over trials of children and adults with cystic fibrosis were included in the review. The number of participants in each trial varied between 14 and 129 with a total of 426 participants included in the review. All the included trials were for a duration of four weeks. The included trials had mostly an unclear risk of bias from the randomisation process as the details of this were not given; they also mostly had a high risk of attrition bias and reporting bias.We could not combine data from all the trials as they compared different formulations. Findings from individual studies provided insufficient evidence to determine the size and precision of the effects of different formulations. Ten studies reported information on the review's primary outcome (nutritional status); however, we were only able to combine data from two small cross-over studies (n = 41). The estimated gain in body weight was imprecise, 0.32 kg (95% confidence interval -0.03 to 0.67, P = 0.07). Combined data from the same studies gave statistically significant results favouring enteric-coated microspheres over enteric-coated tablets for our secondary outcomes stool frequency, abdominal pain and fecal fat excretion. Data from another single small cross-over study also favoured enteric-coated microspheres over non-enteric-coated tablets with adjuvant cimetidine in terms of stool frequency.
AUTHORS' CONCLUSIONS
There is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month. In the only comparison where we could combine any data, the fact that these were cross-over studies is likely to underestimate the level of inconsistency between the results of the studies due to over-inflation of confidence intervals from the individual studies.There is no evidence on the long-term effectiveness and risks associated with pancreatic enzyme replacement therapy. There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency, optimum time to start treatment and variations based on differences in meals and meal sizes. There is a need for a properly designed trial that can answer these questions.
Topics: Adult; Age Factors; Capsules; Child; Cystic Fibrosis; Delayed-Action Preparations; Enzyme Replacement Therapy; Humans; Microspheres; Nutritional Status; Pancreas; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 25310479
DOI: 10.1002/14651858.CD008227.pub2 -
The Cochrane Database of Systematic... Nov 2020Due to a comment received and due to some other identified methodological problems, the present review is withdrawn. (Meta-Analysis)
Meta-Analysis
Due to a comment received and due to some other identified methodological problems, the present review is withdrawn.
Topics: Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Humans; Liver Neoplasms; Microspheres; Randomized Controlled Trials as Topic; Yttrium Radioisotopes
PubMed: 33197051
DOI: 10.1002/14651858.CD011313.pub4 -
International Journal of Biological... Feb 2023Because intelligent hydrogels have good biocompatibility, a rapid response, and good degradability as well as a stimulus response mode that is rich, hydrophilic, and... (Review)
Review
Because intelligent hydrogels have good biocompatibility, a rapid response, and good degradability as well as a stimulus response mode that is rich, hydrophilic, and similar to the softness and elasticity of living tissue, they have received widespread attention and are widely used in biomedical engineering. In this article, we conduct a systematic review of the use of smart hydrogels in biomedical engineering. First, we introduce the properties and applications of hydrogels and compare the similarities and differences between traditional hydrogels and smart hydrogels. Secondly, we summarize the intelligent hydrogel types, the mechanisms of action used by different hydrogels, and the materials for preparing different types of hydrogels, such as the materials for the preparation of temperature-responsive hydrogels, which mainly include gelatin, carrageenan, agarose, amylose, etc.; summarize the morphologies of different hydrogels, such as films, fibers and microspheres; and summarize the application of smart hydrogels in biomedical engineering, such as for the delivery of proteins, antibiotics, deoxyribonucleic acid, etc. Finally, we summarize the shortcomings of current research and present future prospects for smart hydrogels. The purpose of this paper is to provide researchers engaged in related fields with a systematic review of the application of intelligent hydrogels in biomedical engineering. We hope that they will get some inspiration from this work to provide new directions for the development of related fields.
Topics: Biomedical Engineering; Biocompatible Materials; Hydrogels; Tissue Engineering; Bioengineering; Macromolecular Substances
PubMed: 36549612
DOI: 10.1016/j.ijbiomac.2022.12.148 -
Drug Delivery Dec 2023Transarterial radioembolization (TARE) is an established treatment modality for patients with unresectable liver cancer. However, a better understanding of treatment...
Transarterial radioembolization (TARE) is an established treatment modality for patients with unresectable liver cancer. However, a better understanding of treatment parameters that influence microsphere distribution could further improve the therapy. This systematic review examines and summarizes the available evidence on intraprocedural parameters that influence the microsphere distribution during TARE as investigated by in vivo, ex vivo, in vitro and in silico studies. A standardized search was performed in Medline, Embase and Web of Science to identify all published articles investigating microsphere distribution or dynamics during TARE. Studies presenting original research on parameters influencing the microsphere distribution during TARE were included. A total of 42 studies reporting a total of 11 different parameters were included for narrative analysis. The investigated studies suggest that flow distribution is not a perfect predictor of microsphere distribution. Increasing the injection velocity may help increase the similarity between flow and microsphere distributions. Furthermore, the microsphere distributions are very sensitive to the radial and axial catheter position. The most promising parameters for future research which can be controlled in the clinic appear to be microsphere injection velocity as well as the axial catheter position. Up to now, many of the included studies do not take clinical feasibility into account, limiting the translation of results to clinical settings. Future research should therefore focus on the applicability of in vivo, in vitro, or in silico research to patient specific scenarios to improve the efficacy of radioembolization as treatment for liver cancer.
Topics: Humans; Microspheres; Liver Neoplasms
PubMed: 37341184
DOI: 10.1080/10717544.2023.2226366 -
Cardiovascular and Interventional... May 2016To study the effectiveness of prophylactic embolization of hepaticoenteric arteries to prevent gastrointestinal complications during radioembolization. (Review)
Review
PURPOSE
To study the effectiveness of prophylactic embolization of hepaticoenteric arteries to prevent gastrointestinal complications during radioembolization.
METHODS
A PubMed, Embase and Cochrane literature search was performed. We included studies assessing both a group of patients with and without embolization.
RESULTS
Our search revealed 1401 articles of which title and abstract were screened. Finally, eight studies were included investigating 1237 patients. Of these patients, 456 received embolization of one or more arteries. No difference was seen in the incidence of gastrointestinal complications in patients with prophylactic embolization of the gastroduodenal artery (GDA), right gastric artery (RGA), cystic artery (CA) or hepatic falciform artery (HFA) compared to patients without embolization. Few complications were reported when microspheres were injected distal to the origin of these arteries or when reversed flow of the GDA was present. A high risk of confounding by indication was present because of the non-randomized nature of the included studies.
CONCLUSION
It is advisable to restrict embolization to those hepaticoenteric arteries that originate distally or close to the injection site of microspheres. There is no conclusive evidence that embolization of hepaticoenteric arteries influences the risk of complications.
Topics: Brachytherapy; Digestive System; Duodenum; Embolization, Therapeutic; Gallbladder; Gastrointestinal Diseases; Hepatic Artery; Humans; Liver; Liver Neoplasms; Microspheres; Stomach
PubMed: 26935724
DOI: 10.1007/s00270-016-1310-9 -
Journal of Cancer Research and Clinical... Oct 2020Limited treatment options are available in chemotherapy-refractory metastatic colorectal cancer (mCRC). The objective was to conduct a systematic literature review (SLR)... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Limited treatment options are available in chemotherapy-refractory metastatic colorectal cancer (mCRC). The objective was to conduct a systematic literature review (SLR) and exploratory network meta-analysis (NMA) to compare the tolerability and effectiveness of SIRT with Y-90 resin microspheres, regorafenib, TAS-102 (trifluridine/tipiracil), and best supportive care (BSC) as third-line treatment in patients with mCRC.
METHODS
An SLR was conducted to identify studies comparing two or more of the treatments and reporting overall survival (OS), progression-free survival, tumor response, or adverse event (AE) incidence. An exploratory NMA was conducted to compare hazard ratios (HRs) for OS using Markov chain Monte Carlo (MCMC) techniques.
RESULTS
Seven studies were identified in the SLR: two double-blind randomized-controlled trials (RCT) for each drug, one open-label RCT, and two non-randomized comparative studies for SIRT. Patient selection criteria differed between studies, with SIRT studies including patients with liver-dominant colorectal metastases. Nausea and vomiting were more frequent with TAS-102 than regorafenib or SIRT; diarrhea was more common with TAS-102 and regorafenib than SIRT. The exploratory NMA suggested that all active treatments improved OS, with HRs of 0.48 (95% CrI 0.30-0.78) for SIRT with Y-90 resin microspheres, 0.63 (0.38-1.03) for TAS-102, and 0.67 (0.40-1.08) for regorafenib each compared to BSC.
CONCLUSIONS
Regorafenib, TAS-102 and SIRT using Y-90 resin microspheres are more effective than BSC in third-line treatment of mCRC; however, study heterogeneity made comparisons between active treatments challenging. SIRT is a viable treatment for third-line mCRC and its favorable AE profile should be considered in the therapeutic decision-making process.
Topics: Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Colorectal Neoplasms; Double-Blind Method; Drug Combinations; Humans; Microspheres; Neoplasm Metastasis; Network Meta-Analysis; Palliative Care; Phenylurea Compounds; Progression-Free Survival; Pyridines; Pyrrolidines; Randomized Controlled Trials as Topic; Thymine; Trifluridine; Uracil; Yttrium Radioisotopes
PubMed: 32715436
DOI: 10.1007/s00432-020-03315-6 -
Pediatric Neurosurgery 2024Middle meningeal artery (MMA) embolization has been increasingly applied in adult populations for the treatment of chronic subdural hematomas (cSDH). There is a paucity... (Review)
Review
BACKGROUND
Middle meningeal artery (MMA) embolization has been increasingly applied in adult populations for the treatment of chronic subdural hematomas (cSDH). There is a paucity of literature on the indications, safety, and outcomes of MMA embolization in the pediatric population.
SUMMARY
A systematic literature review on pediatric patients undergoing MMA embolization was performed. We also report the case of successful bilateral MMA embolization for persistent subdural hematomas following resection of a juvenile pilocytic astrocytoma. Persistent bilateral subdural hematomas following resection of a large brain tumor resolved following MMA embolization in a 13-year-old male. Indications for MMA embolization in the pediatric literature included cSDH (6/13, 46.2%), treatment or preoperative embolization of arteriovenous fistula or arteriovenous malformation (3/13, 23.1%), preoperative embolization for tumor resection (1/13, 7.7%), or treatment of acute epidural hematoma (1/13, 7.7%). Embolic agents included microspheres or microparticles (2/13, 15.4%), Onyx (3/13, 23.1%), NBCA (3/13, 23.1%), or coils (4/13, 30.8%).
KEY MESSAGES
Whereas MMA embolization has primarily been applied in the adult population for subdural hematoma in the setting of cardiac disease and anticoagulant use, we present a novel application of MMA embolization in the management of persistent subdural hematoma following resection of a large space-occupying lesion. A systematic review of MMA embolization in pediatric patients currently shows efficacy; a multi-institutional study is warranted to further refine indications, timing, and safety of the procedure.
Topics: Male; Adult; Humans; Child; Adolescent; Meningeal Arteries; Embolization, Therapeutic; Hematoma, Subdural, Chronic; Hematoma, Epidural, Cranial
PubMed: 37903471
DOI: 10.1159/000534895