scholarly journals Efficacy and Safety of Central Memory T Cells Combined With Adjuvant Therapy to Prevent Recurrence of Hepatocellular Carcinoma With Microvascular Invasion: A Pilot Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Jianqiang Cai ◽  
Jianjun Zhao ◽  
Defang Liu ◽  
Huangfan Xie ◽  
Hailong Qi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Pilot Study ◽  
Adjuvant Therapy ◽  
Adverse Events ◽  
Clinical Benefit ◽  
Microvascular Invasion ◽  
Control Group ◽  
Tace Treatment ◽  
Curative Hepatectomy

BackgroundPostoperative adjuvant transcatheter arterial chemoembolization (TACE) following curative hepatectomy has been reported to improve the clinical outcomes of hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI), but more endeavors are required to achieve greater clinical benefit. Central memory T-cell (Tcm) self-transfusion has shown superior antitumor activity in several preclinical studies; however, clinical studies are rare. The aim of this study was to evaluate the clinical benefit and safety of combination treatment with Tcm self-transfusion and TACE as adjuvant treatment in HCC patients with MVI after curative hepatectomy.MethodsFrom October 2016 to September 2018, primary HCC patients with histologically confirmed MVI who underwent curative hepatectomy at the Cancer Hospital of the Chinese Academy of Medical Sciences were recruited for this study. The patients were divided into a Tcm group (combined Tcm self-transfusion with TACE treatment) or a control group (TACE treatment alone) according to their willingness. The recurrence-free survival (RFS), quality-of-life (QOL) score, and adverse events of each patient were recorded within 2 years.ResultsA total of 52 patients were enrolled, and 48 were eligible for the final data analysis. The median follow-up time was 20.5 months (95% CI: 17.05–22.55 months). The median RFS time was 9.5 months in the control group; the cutoff date was not reached in the Tcm group (when the follow-up duration was 12 months, p = 0.049, HR = 0.40; 95% CI: 0.16–0.99). Compared with the control group, 1- and 2-year RFS rates were higher in the Tcm group (72.0% vs. 46.4% and 58.18% vs. 39.14%, respectively). Multivariate analysis did not indicate that Tcm treatment was an independent prognostic factor associated with HCC recurrence (p = 0.107, HR = 2.312; 95% CI: 0.835–6.400), which might be due to the small sample size of this study. Nevertheless, Tcm treatment effectively improved a reduced QOL due to HCC and liver function injury. Finally, the safety profile of Tcm treatment in this study was good, without any serious adverse events.ConclusionsThis pilot study showed that Tcm self-transfusion combined with TACE treatment might be a beneficial adjuvant therapy with good safety for primary HCC patients with MVI after curative hepatectomy.Trial registration numberNCT03575806

Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study

2019 ◽  
pp. bmjspcare-2018-001542 ◽  
Author(s):  
Eduardo Guilherme D’Alessandro ◽  
Daniela Ribeiro Nebuloni Nagy ◽  
Christina May Moran de Brito ◽  
Elisangela Pinto Marinho Almeida ◽  
Linamara Rizzo Battistella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Pilot Study ◽  
Adverse Events ◽  
Control Group ◽  
Life Questionnaire ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Chemotherapy-induced peripheral neuropathy (CIPN) can cause loss of independence and poor quality of life (QoL) due to severe disabilities, but in spite of its importance there is still a lack of data for the management of CIPN. Acupuncture has showed promising results and may be a cost-effective option for the treatment.ObjectivesTo evaluate the effect of acupuncture treatment on neurological symptoms of CIPN and QoL of oncological patients.MethodsWe performed a clinical, single-centre, randomised and controlled pilot study that involved 33 adult patients with cancer and CIPN randomised into two groups (control and acupuncture treated with 10 sessions, two times per week). Both groups were subjected to a complete physical examination and clinical assessment with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale V.2.0, FIM Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Scale and Visual Analogue Scale for pain before and 5 weeks after treatment.ResultsThere were no adverse events, and we found statistical differences in groups in physical (p=0.03) and function (p=0.04) domains of EORTC QLQ-C30 when comparing control and acupuncture groups. About NCI CTCAE Scale and neuropathy sensory symptoms, we found better results in acupuncture group, comparing pretreatment and post-treatment analyses (p=0.01). In control group, we have no differences after 5 weeks (p=0.11).ConclusionAlthough these results suggest an interesting effect of acupuncture on this patient population, the clinical significance has remained unclear. Given the tendency towards benefit and the lack of adverse effects, the authors recommend a follow-up acupuncture trial using higher follow-up time and better sample size.Trial registration numberNCT02309164.

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

scholarly journals The Use of the Oxygenated AirdriveTM Machine Perfusion System in Kidney Graft Preservation: A Clinical Pilot Study

2020 ◽  
Vol 61 (6) ◽  
pp. 153-162
Author(s):  
Julia H.E. Houtzager ◽  
Sebastiaan David Hemelrijk ◽  
Ivo C.J.H. Post ◽  
Mirza M Idu ◽  
Frederike J. Bemelman ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Pilot Study ◽  
Adverse Events ◽  
Deceased Donor ◽  
Kidney Graft ◽  
Machine Perfusion ◽  
End Points ◽  
Viable Solution ◽  
Technical Failures

Background: The shortage of donor kidneys has led to the use of marginal donors, e.g., those whose kidneys are donated after circulatory death. Preservation of the graft by hypothermic machine perfusion (HMP) provides a viable solution to reduce warm ischemic damage. This pilot study was undertaken to assess the feasibility and patient safety of the AirdriveTM HMP system in clinical kidney transplantation. Methods: Five deceased-donor kidneys were preserved using the oxygenated Airdrive HMP system between arrival at the recipient center (Amsterdam UMC) and implantation in the patient. The main study end-points were adverse effects due to the use of Airdrive HMP. Secondary end-points were clinical outcomes and perfusion parameters. All events occurring during the transplantation procedure or within 1 month of follow-up were monitored. Results: Five patients were included in this pilot study. No technical failures were observed during the preservation period using the Airdrive HMP. Mean perfusion parameters were: duration 8.5 h (3–15 h), pressure 25 mm Hg (18–25 mm Hg), flow 49.77 mL/min (19–58 mL/min), resistance 0.57 mm Hg/min/mL (0.34–1.3 mm Hg/min/mL), and temperature 8.2 °C (2–13°C). Mean cold ischemia time (CIT) was 20.2 h (11–29.5 h). No adverse events or technical failures were observed during preservation and transplantation or during the 1-month follow-up. Conclusions: This pilot study showed the feasibility of the use of the Airdrive HMP system with no adverse events in clinical kidney transplantation.

scholarly journals Auricular acupressure for hot flashes in patients with prostate cancer: protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Jianfu Zhou ◽  
Rongwu Lin ◽  
Xuehua Liu ◽  
Liguo Lv ◽  
Shusheng Wang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Pilot Study ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Preliminary Evidence ◽  
Control Group ◽  
Random Allocation ◽  
Clinical Trial Registry ◽  
Auricular Acupressure

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.

Stereotactic Body Radiation Therapy as a Salvage Treatment for Single Viable Hepatocellular Carcinoma at the Site of Incomplete Transarterial Chemoembolization

2021 ◽  
Author(s):  
Sumin Lee ◽  
Jinhong Jung ◽  
Jin-hong Park ◽  
So Yeon Kim ◽  
Jonggi Choi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Radiation Therapy ◽  
Adverse Events ◽  
Transarterial Chemoembolization ◽  
Stereotactic Body Radiation Therapy ◽  
Medical Center ◽  
Salvage Treatment ◽  
Iodized Oil ◽  
Stereotactic Body Radiation

Abstract Background: To evaluate the clinical outcomes of patients who received stereotactic body radiation therapy (SBRT) for single viable hepatocellular carcinoma (HCC) at the site of incomplete transarterial chemoembolization (TACE).Methods: Incomplete TACE was defined as (1) evidence of viable HCC at the site of TACE on follow-up images following one or more consecutive TACEs, (2) no definite tumor staining on celiac angiogram, or (3) no definite iodized oil uptake on post-embolization angiogram or computed tomography. A total of 302 patients were treated between 2012 and 2017 at Asan Medical Center (Seoul, South Korea). Doses of 10–15 Gy per fraction were given over 3–4 consecutive days. Treatment-related adverse events were evaluated according to the common terminology criteria for adverse events, version 4.03.Results: The median follow-up duration was 32.9 months (interquartile range [IQR], 23.6–41.7) and the median tumor size was 2.0 cm (range, 0.7–6.9). The local control (LC) and overall survival rates at 3 years were 91.2% and 72.7%, respectively. 95.4% of the tumors reached complete response (CR) during the entire follow-up period (anyCR). The median interval from SBRT to anyCR was 3.4 months (IQR, 1.9–4.7), and 39.9% and 83.3% of the lesions reached CR at 3- and 6-months after SBRT, respectively. Radiation-induced liver disease was observed in 8 (2.6%) patients. No patients experienced gastroduodenal bleeding within the radiation field.Conclusion: SBRT should be considered a feasible salvage treatment option for HCC after incomplete TACE.

Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial

Endoscopy ◽  
2019 ◽  
Vol 52 (02) ◽  
pp. 115-122 ◽  
Author(s):  
Theodor Voiosu ◽  
Ivo Boskoski ◽  
Andrei M. Voiosu ◽  
Andreea Benguș ◽  
Agata Ladic ◽  
...  
Keyword(s):  
Adverse Events ◽  
Multivariable Analysis ◽  
Difficulty Level ◽  
Control Group ◽  
Technical Success ◽  
Endoscopic Techniques ◽  
Trainee Group ◽  
Standard Report ◽  
Multicenter Prospective Observational Study

Abstract Background Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. Methods This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. Results 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. Conclusion Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.

scholarly journals Hepatocellular carcinoma with type II–III portal vein tumour thrombosis: treatment using transarterial chemoembolisation and microwave ablation

2021 ◽  
Vol 94 (1117) ◽  
pp. 20200415
Author(s):  
Wen Peng Zhao ◽  
Honglu Li ◽  
Jiang Guo ◽  
Liang Cai ◽  
Youjia Duan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Portal Vein ◽  
Microwave Ablation ◽  
Type Ii ◽  
Time To Progression ◽  
Treatment Alternative ◽  
Transarterial Chemoembolisation ◽  
Grade 3

Objective: To evaluate the use of transarterial chemoembolisation (TACE) combined with microwave ablation (MWA) to treat patients with hepatocellular carcinoma (HCC) and type Ⅱ–Ⅲ portal vein tumour thrombosis (PVTT) intolerant to targeted drug (TG) therapy. Methods: A total of 18 patients with HCC and type Ⅱ–Ⅲ PVTT intolerant to TG were enrolled between June 2015 and December 2019, who were treated with TACE + MWA (MWA group). 24 patients were treated with TACE + TG (TG group; control cohort). Time to progression and overall survival (OS) were analysed along with the incidence of adverse events. Results: The median follow-up time was 19.0 months (9.0–32.0 months). The median OS was 17.0 months (8.3–29.3 months; MWA group) and 13.5 months (5.5–22.5 months; TG group) and was not significantly different. The 1- and 2 year OS was also comparable (MWA group: 66.7%, 44.4% vs Target group: 41.7%, 29.2%). Time to progression showed no distinct differences (MWA group: 11.5 months; TG group: 9.0 months) between the two groups. Moreover, the incidence of major Grade 3–4 adverse events in the MWA group (5.6%) was similar to those in the TG group (8.3%). Conclusion: TACE + MWA and TACE + TG were comparable in their safety and efficacy in patients with HCC, type Ⅱ–Ⅲ PVTT, and intolerance to TG. Advances in knowledge: TACE + MWA can be used as a palliative treatment alternative for TACE + TG in patients with HCC, type Ⅱ–Ⅲ PVTT, and intolerance to TG.

scholarly journals Five-year results of a clinical pilot study utilizing a pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis

2018 ◽  
Vol 29 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Sergey Mlyavykh ◽  
Steven C. Ludwig ◽  
Christopher K. Kepler ◽  
D. Greg Anderson
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Spinal Stenosis ◽  
Spinal Canal ◽  
Ct Scans ◽  
Time Points ◽  
Lengthening Osteotomy ◽  
Lumbar Spinal ◽  
Disease Specific

OBJECTIVELumbar spinal stenosis (LSS) is a common condition that leads to significant disability, particularly in the elderly. Current therapeutic options have certain drawbacks. This study evaluates the 5-year clinical and radiographic results of a minimally invasive pedicle-lengthening osteotomy (PLO) for symptomatic LSS.METHODSA prospective, single-arm, clinical pilot study was conducted involving 20 patients (mean age 61.7 years) with symptomatic LSS treated by a PLO procedure at 1 or 2 lumbar levels. All patients had symptoms of neurogenic claudication or radiculopathy secondary to LSS, and had not improved after a minimum 6-month course of nonoperative treatment. Eleven patients had a Meyerding grade I degenerative spondylolisthesis in addition to LSS. Clinical outcomes were measured using the Oswestry Disability Index, Zürich Claudication Questionnaire, 12-Item Short Form Health Survey, and a visual analog scale for back and leg pain. Procedural variables, neurological outcomes, adverse events, and radiological imaging (plain radiographs and CT scans) were collected at the 1.5-, 3-, 6-, 9-, 12-, 24-, and 60-month time points.RESULTSThe PLOs were performed through percutaneous incisions, with minimal blood loss in all cases. There were no operative complications. Four adverse events occurred during the follow-up period. Statistically significant improvement was observed in each of the outcome instruments and maintained over the 5-year follow-up period. Imaging studies, reviewed by an independent radiologist, showed no evidence of device subsidence, migration, breakage, or heterotopic ossification. Thin-slice CT scans documented healing of the osteotomy site in all patients at the 6-month time point and an increase of 115% in the mean cross-sectional area of the spinal canal.CONCLUSIONSTreatment of patients with symptomatic LSS with a PLO procedure provided substantial enlargement of the area of the spinal canal and favorable clinical results for both disease-specific and non–disease-specific outcome measures at all follow-up time points out to 5 years. Future research is needed to compare this technique to alternative therapies for LSS.

Adherence to Imatinib Mesylate Treatment: Two Years Follow up

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4267-4267 ◽  
Author(s):  
Carlos A. Doti ◽  
German R Stemmelin ◽  
Elena Beatriz Moiraghi ◽  
María Gabriela Flores ◽  
Juan Garcia ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acquired Resistance ◽  
Chronic Phase ◽  
Complete Information ◽  
Cytogenetic Response ◽  
Hematological Toxicity ◽  
Control Group ◽  
Hematological Response ◽  
Complete Hematological Response

Abstract Background: Since the introduction of Imatinib (IM), the treatment of chronic myeloid leukemia (CML) experienced its most important change. As this drug became the first line for the treatment of CML, we learned that under-dosing was associated with a delay in achieving cytogenetic response and the development of acquired resistance. Last year we presented a case-control study that analyzed how compliance affects the cytogenetic response to Imatinib. This is an update of that data. Materials and Methods: Twenty-four patients with newly diagnosed Ph (+) chronic phase CML (CP-CML) were included and followed for 24 months. Patients received 400mg of IM and were asked to note down all taken doses, and reasons for non-compliance. Follow up visits were scheduled every 28–30 days and prescriptions were filled in order to last for only 30 days. During each visit, the medication was counted and non-adherence reasons were determined. Adverse events were graded according to the CTC and modifications in the Imatinib dose were only allowed with related adverse events with a CTC score ≥3. As a control group, we matched each case with a Phi + CP-CML patient from our data base of the same sex and similar age as the case patient. All control patients had to have complete information about dosing and response. They all received initial treatment with IM 400mg; thereafter, dose was adjusted according to each physician’s criteria. Compliance was measured as: mg prescribed/mg taken during the study period. Results: Twenty-four patients, 14 males median age 56 yo (range: 24–83), were included in the study. Three were lost to follow up, leaving only twenty-one for analysis of compliance. At the end of the first year, all patients had complete hematological response. Compliance during these 12 months was 96.1, which is clearly superior to the 80% reported in the setting of clinical trials. All patients had a complete hematological response, 89.9 achieved a major cytogenetic response (MCyR) and 87.4 a complete cytogenetic response (CCyR), compared to 60 of the control group with a MCyR (p=0.027) and 57.8 a CCyR (p=0.025). During the second year, four patients lost CCyR, three responded to an increase in IM dose and one progressed to an accelerated phase and died. Compliance fell slightly during this period to 90.86% which was reflected in 81.66% CCyR, which was still statistically higher than the 54% of major responses in the control group (p=0.033). In both groups, none of the patients not achieving MCyR at 12 months achieved MCyR at 24 months. Hematological toxicity was more frequently observed within the first 6 months of treatment and after the increase in dosage. Severity and incidence of adverse events were similar in both groups, and were the main reasons for interruption or reduction of IM dose in the control group. The only additional difference besides compliance between the two groups was the average IM dose prescribed during the duration of the study (cases group: 430mg – control group: 330mg). Conclusions: Adherence to Imatinib is associated with an improvement in cytogenetic response that can be seen even at two years after the start of therapy. Since outcome and development of resistance seem to be associated with compliance to therapy, emphasis should be put on maintaining treatment at an adequate dose for as long as possible.

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