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Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: A multicenter, randomized controlled clinical trial
Choi JH, Cho IR, Lee SH, Kim JS, Park N, Lee MW, Jang DK, Paik WH, Ahn DW, Ryu JK, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2023
Abstract
BACKGROUND Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP). AIMS In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding. METHODS A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray. RESULTS A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events. CONCLUSIONS The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607).
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Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure
Wu C, Peng W, Cheng D, Gu H, Liu F, Peng S, Fu L
Journal of clinical and translational hepatology. 2023;11(2):433-440
Abstract
BACKGROUND AND AIMS Nonbiological artificial liver (NBAL) is frequently used as a first-line treatment for hepatitis B virus-associated acute-on-chronic liver failure (HBV-ACLF). This study aimed to compare the therapeutic efficacy and cost-effectiveness ratio (CER) of comprehensive medical treatment, plasma exchange (PE), and double plasma molecular adsorption system (DPMAS) plus half-dose PE (DPMAS+PE) in patients with HBV-ACLF. METHODS A total of 186 patients with HBV-ACLF randomly received comprehensive medical treatment, PE, or DPMAS+PE and were prospectively evaluated. Patients were divided into four subgroups based on the pretreatment prothrombin activity (PTA): Group I (PTA>40%), group II (PTA 30-40%), group III (PTA 20-30%), and group IV (PTA<20%). The main outcome measures were 28 day effectiveness; 90 day liver transplantation-free survival; change of biochemical parameters; and CER. RESULTS DPMAS+PE treatment was associated with significantly higher 28 day effectiveness and 90 day liver transplantation-free survival compared with PE treatment in patients with group I liver failure. Clearance of serum total bilirubin (TBIL), AST, and creatinine (Cr) were significantly higher in the DPMAS+PE group than in the PE group. For subjects with group I liver failure, DPMAS+PE treatment had advantages of lower CER values and better cost-effectiveness. CONCLUSIONS Compared with comprehensive medical treatment and PE alone, DPMAS with half-dose sequential PE treatment more effectively improved TBIL, AST, and Cr in HBV-ACLF patients, improved 28 day effectiveness and 90 day survival rates in patients with group I liver failure, and was more cost effective. DPMAS+PE is a viable NBAL approach for treatment of HBV-ACLF.
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Effects of 20% albumin infusion therapy during liver transplantation on plasma neutrophil gelatinase-associated lipocalin level: a randomized controlled trial
Kim D, Jeayoun Kim, Han S, Hyunjoo Jung, Park HD, Ko JS, Gwak MS, Kim GS
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 2023
Abstract
The risk of acute kidney injury (AKI) after liver transplantation was lower in patients with serum albumin levels≥3.0 mg/dL during surgery. We tested whether intraoperative infusion of 20% albumin affects neutrophil gelatinase-associated lipocalin (NGAL) level, a reliable indicator of AKI. We randomly assigned 134 patients undergoing liver transplantation into albumin group (n=70, 20% albumin 200 mL) and the control group (n=66, crystalloid solution 200 mL). The two study fluids were infused at 100 mL/hour from the start of the anhepatic phase. The primary outcome was plasma NGAL level at 1 hour after graft reperfusion. Albumin level at the start of graft reperfusion was significantly greater in albumin group than in the control group (2.9 [2.4-3.3] g/dL vs. 2.3 [2.0-2.7] g/dL, P<0.001). NGAL level at 1 hour after graft reperfusion was not significantly different between the two groups (100.2 [66.7-138.8] ng/mL vs. 92.9 [70.8-120.6] ng/mL, P=0.46), and AKI risk was not either (63.9% vs. 67.8%, adjusted P=0.73). There were no significant differences between the two groups regarding hospital readmission within 30 days/90 days after transplantation (32.6% vs. 41.5%, adjusted P=0.19 and 55% vs. 55.7%, adjusted P=0.87). Graft survival probability at 30 days/90 days/1 year after transplantation was 90.0%/84.3%/78.6% in albumin group and 97.0%/90.9%/89.4% in the control group (HR=1.6 [0.6-4.0], adjusted P=0.31). In conclusion, intraoperative infusion of 20% albumin 200 mL increased albumin level but failed to maintain serum albumin≥3.0 mg/dL during surgery. The hypertonic albumin therapy did not significantly affect plasma NGAL level and clinical outcomes including AKI.
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Effect of blood transfusion post kidney transplantation on de novo human leukocytes antigen donor-specific antibody development and clinical outcomes in kidney transplant recipients: A systematic review and meta-analysis
Kang ZY, Ma S, Liu W, Liu C
Transplant immunology. 2023;:101801
Abstract
The relationship between blood transfusion following kidney transplantation (KT) and the development of de novo donor-specific antibodies (dnDSA) is controversial. This was investigated by conducting a meta-analysis of studies on patients who underwent KT with or without blood transfusion, and by evaluating the effect of post-KT blood transfusion on clinical outcomes of kidney transplant recipients. Relevant studies in the PubMed, EMBASE, and Cochrane Library databases were identified from inception to July 1, 2022. Two reviewers independently extracted data from the selected articles and estimated study quality. A fixed effects or random effects model was used to pool data according to the heterogeneity among studies. Data included in the meta-analysis were derived from 11 studies with a total of 19,543 patients including 6191 with and 13,352 without blood transfusion post-KT. We assessed the pooled associations between blood transfusion and occurrence of dnDSA and clinical outcomes of transplant recipients. Blood transfusion was strongly correlated with the development of dnDSA (relative risk [RR] = 1.40, 95% confidence interval [CI]: 1.17-1.67; P < 0.05). Patients with blood transfusion had a higher risk of developing anti-human leukocyte antigen (HLA) class I dnDSA than non-transfused patients (RR = 1.75, 95% CI: 1.14-2.69; P < 0.05) as well as significantly higher rates of antibody-mediated rejection (AMR) (RR = 1.41, 95% CI: 1.21-2.35; P < 0.05) and graft loss (RR = 1.75, 95% CI: 1.30-2.35; P < 0.05). There were no statistically significant differences between the two groups in the development of anti-HLA antibodies, anti-HLA class II dnDSA, and anti-HLA class I and II dnDSA; delayed graft function; T cell-mediated rejection; acute rejection; borderline rejection; or patient death. Our results suggest that blood transfusion was associated with dnDSA development in KT recipients. The findings of this systematic review also suggest that post-KT blood transfusion recipients have a higher risk of AMR, and graft loss compared with non-transfused patients. Evidence from this meta-analysis indicates that the use of blood transfusion post-KT is associated with a significantly higher risk of immunological sensitization. More and higher quality results from large randomized controlled trials are still needed to inform clinical practice.
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5.
Viscoelastic versus conventional coagulation tests to reduce blood product transfusion in patients undergoing liver transplantation: A systematic review and meta-analysis
Aceto P, Punzo G, Di Franco V, Teofili L, Gaspari R, Wolfango Avolio A, Del Tedesco F, Posa D, Lai C, Sollazzi L
European journal of anaesthesiology. 2022
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Editor's Choice
Abstract
BACKGROUND Recent literature suggests viscoelastic test (VET)-guided transfusion management could be associated with reduced blood product administration in patients undergoing liver transplantation. OBJECTIVES To assess the effectiveness of coagulation management guided by VETs compared with conventional coagulation tests (CCTs) in reducing blood product transfusion in patients undergoing liver transplantation. DESIGN Systematic review and meta-analysis of randomised (RCTs) and nonrandomised clinical trials performed according to PRISMA guidelines. The protocol was previously published (PROSPERO CRD42021230213). DATA SOURCES The Cochrane Central Library, PubMed/MEDLINE, Embase and the Transfusion Evidence Library were searched up to 30th January 2022. ELIGIBILITY CRITERIA Setting: operating room. Patients: liver transplantation recipients. Intervention: use of VETs versus CCTs. Main outcome measures: the primary outcome was the mean number of transfused units for each blood product including red blood cells (RBCs), fresh frozen plasma (FFP), platelets (PLTs) and cryoprecipitate. Secondary outcomes included mortality rate, intensive care unit (ICU) and hospital length of stay (LOS). RESULTS Seventeen studies (n = 5345 patients), 15 observational and two RCTs, were included in this review. There was a mean difference reduction in RBCs [mean difference: -1.40, 95% confidence interval (95% CI), -1.87 to -0.92; P < 0.001, I2 = 61%) and FFP units (mean difference: -2.98, 95% CI, -4.61 to -1.35; P = < 0.001; I2 = 98%) transfused in the VETs group compared with the CCTs one. A greater amount of cryoprecipitate was administered in the VETs group (mean difference: 2.71, 95% CI, 0.84 to 4.58; P = 0.005; I2 = 91%). There was no significant difference in the mean number of PLT units, mortality, hospital and ICU-LOS. CONCLUSION Our meta-analysis demonstrated that VETs implementation was associated with reduced RBC and FFP consumption in liver transplantation patients without effects on mortality and hospital and ICU-LOS. The certainty of evidence ranged from moderate to very low. Further well conducted RCTs are needed to improve the certainty of evidence.
PICO Summary
Population
Patients undergoing liver transplantation (17 studies, n= 5,345).
Intervention
Coagulation management guided by viscoelastic tests (VETs group).
Comparison
Conventional coagulation tests (CCTs group).
Outcome
There was a mean difference reduction in red blood cells (mean difference: -1.40, 95% confidence interval (95% CI) -1.87 to -0.92, I2 = 61%) and fresh frozen plasma units (mean difference: -2.98, 95% CI -4.61 to -1.35; I2 = 98%) transfused in the VETs group compared with the CCTs group. A greater amount of cryoprecipitate was administered in the VETs group (mean difference: 2.71, 95% CI, 0.84 to 4.58; I2 = 91%). There was no significant difference in the mean number of platelets units, mortality, hospital and intensive care unit (ICU) and hospital length of stay (LOS).
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The Effect of Platelet-Rich Plasma on Healing Time in Patients Following Pilonidal Sinus Surgery: A Systematic Review
Khan QI, Baig H, Al Failakawi A, Majeed S, Khan M, Lucocq J
Cureus. 2022;14(8):e27777
Abstract
BACKGROUND Pilonidal disease (PD) is a debilitating condition characterised by the infection of subcutaneous tissue in the sacrococcygeal area. It is associated with a high risk of recurrence, pain, infection, and purulent discharge. The two main surgical methods of pilonidal sinus disease include excision with primary closure/flap repair or excision of the sinus with healing by secondary intent. Wounds left open to heal by secondary intent remain extremely common due to their association with reduced risk of recurrence, however, it is associated with prolonged healing times. This study aims to determine whether platelet-rich plasma (PRP) reduces healing time in patients post pilonidal sinus surgery with healing by secondary intent compared to simple wound dressings. METHOD Six databases were searched from their date of origin to May 30, 2022 for randomised control trials using predetermined inclusion and exclusion criteria. Only four papers were selected for review as per the Population, Intervention, Comparison, Outcomes and Study design (PICOS) criteria. Critical appraisal was carried out according to the Scottish Intercollegiate Guidelines Network Methodology Checklist for Randomised Control Trials and was assessed for risk of bias according to the Cochrane Handbook for Systematic Review of Interventions. The pooled effect size was calculated using the fixed-effect model. A homogeneity of pooled effect size for the studies was also found (Cochrane Q test, p-value = 0.97 I-square = 0.0%). RESULT Four studies (n = 336) were included in this review. Three of the four studies reported a statistically significant reduction in time taken in healing the wound. The mean difference between the intervention (PRP group) and the control group was 13.01 days, (95% CI 12.15-13.86 days, p < 0.00001). All of the included studies also reported a statistically significant reduction in time taken to return to work/activities of daily living in the treatment group compared to the control group (MD 9.68 days, 95% CI 9.16-10.21 days, p < 0.00001). CONCLUSION This study shows that PRP is effective in reducing healing time and is associated with a significantly shorter period taken to return to work/activities of daily living in patients post pilonidal sinus surgery, which was the primary and secondary outcome investigated in this systematic review, respectively. PRP should routinely be offered to patients undergoing excisional pilonidal sinus surgery for the aforementioned benefits.
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Scheduled second look endoscopy after endoscopic hemostasis to patients with high risk bleeding peptic ulcers: a Randomized Controlled Trial
Pittayanon R, Suen BY, Kongtub N, Tse YK, Rerknimitr R, Lau JYW
Surgical endoscopy. 2022
Abstract
BACKGROUND The recommendation of second look endoscopy (SLOGD) in selected patients at high risk for rebleeding has been inconclusive. This study aimed to evaluate the benefit of SLOGD in selected patients predicted at high risk of recurrent bleeding. METHODS From a cohort of 939 patients with bleeding peptic ulcers who underwent endoscopic hemostasis, we derived a 9-point risk score (age > 60, Male, ulcer ≥ 2 cm in size, posterior bulbar or lesser curve gastric ulcer, Forrest I bleeding, haemoglobin < 8 g/dl) to predict recurrent bleeding. We then validated the score in another cohort of 1334 patients (AUROC 0.77). To test the hypothesis that SLOGD in high-risk patients would improve outcomes, we did a randomized controlled trial to compare scheduled SLOGD with observation alone in those predicted at high risk of rebleeding (a score of ≥ 5). The primary outcome was clinical bleeding within 30 days of the index bleed. RESULTS Of 314 required, we enrolled 157 (50%) patients (SLOGD n = 78, observation n = 79). Nine (11.8%) in SLOGD group and 14 (18.2%) in observation group reached primary outcome (absolute difference 6.4%, 95% CI - 5.0% to 17.8%). Twenty-one of 69 (30.4%) patients who underwent SLOGD needed further endoscopic treatment. No surgery for bleeding control was needed. There were 6 vs. 3 of 30-day deaths in either group (p = 0.285, log rank). No difference was observed regarding blood transfusion and hospitalization. CONCLUSIONS In this aborted trial that enrolled patients with bleeding peptic ulcers at high-risk of recurrent bleeding, scheduled SLOGD did not significantly improve outcomes. ClinicalTrials.gov:NCT02352155.
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Lack of Efficacy and Safety of Eculizumab for Treatment of Antibody-Mediated Rejection Following Renal Transplantation
Heo S, Park Y, Lee N, Kim Y, Kim YN, Shin HS, Jung Y, Rim H, Rennke HG, Chandraker A
Transplantation proceedings. 2022
Abstract
BACKGROUND We evaluated the efficacy and safety of eculizumab in comparison with plasmapheresis and intravenous immunoglobulin therapy in renal transplant recipients diagnosed with antibody-mediated rejection (AMR). METHODS This was a multicenter, open-label, prospective, randomized analysis. The patients were randomized by therapy type (eg, eculizumab infusions or standard of care [SOC]: plasmapheresis/intravenous immunoglobulin). The patients (ie, eculizumab arm: 7 patients, SOC arm: 4 patients) were evaluated for the continued presence of donor-specific antibodies (DSAs) and C4d (staining on biopsy), as well as histologic evidence, using repeat renal biopsy after treatment. RESULTS The allograft biopsies revealed that eculizumab did not prevent the progression to transplant glomerulopathy. Only 2 patients in the SOC arm experienced rejection reversal, and no graft losses occurred in either group. After AMR treatment, the DSA titers generally decreased compared to titers taken at the time of AMR diagnosis. There were no serious adverse effects in the eculizumab arm. CONCLUSIONS Eculizumab alone cannot treat AMR effectively and does not prevent acute AMR from progressing to chronic AMR or transplant glomerulopathy. However, it should be considered as a potential alternative therapy because it may be associated with decreased DSA levels.
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The role of polyglycolic acid sheets in the management of post-endoscopic submucosal dissection gastrointestinal bleeding and esophageal stricture: A PRISMA compliant systematic review and meta-analysis
Peng S, Huang S, Xia H, Tan S, Zhong C, Peng Y, Lü M, Tang X
Medicine. 2022;101(26):e29770
Abstract
BACKGROUND As a relatively minimally invasive technique, endoscopic submucosal dissection (ESD) is widely used for the treatment of gastrointestinal lesions. However, it is associated with complications, such as postoperative bleeding, stricture, and perforation. A covering method using polyglycolic acid (PGA) sheets for ESD-induced ulcers has been reported to be effective in reducing the risk of post-ESD bleeding and esophageal stricture. Herein, we conducted a systematic review and meta-analysis to evaluate the role of PGA sheets in the prevention of gastrointestinal bleeding and esophageal stricture after ESD. METHODS We searched PubMed, Web of Science, and the Cochrane Library databases on October 15, 2019. All eligible articles were selected based on the predefined inclusion and exclusion criteria. The main outcomes were the rates of post-ESD gastrointestinal bleeding and esophageal stricture. Cochrane's Q statistic and I2 test were used to identify heterogeneity between the studies. When there was no obvious heterogeneity (I2 < 50%, P > .1), a fixed-effect model was used. When there was obvious heterogeneity (I2 > 50%, P < .1), a random effect model was used. Funnel plots and the Egger regression test were used to assess publication bias. RESULTS Fifteen articles were included in the meta-analysis, of which 7 were exclusively about the use of PGA sheets to prevent postoperative gastrointestinal bleeding, and the remaining reported the use of PGA sheets to prevent postoperative esophageal stenosis. Our analysis showed that preventive therapy with PGA sheets decreased the rates of post-ESD gastrointestinal bleeding (risk ratio [RR] = 0.35, 95% confidential interval [CI]: 0.19-0.64, P < .001) and esophageal stricture (RR = 0.46, 95% CI: 0.27-0.79, P = .005), and the gastrointestinal bleeding and esophageal stricture rates after preventive treatment with PGA sheets were 5.7% (95% CI: 3.6%-8.8%) and 20.6% (95% CI: 14.5%-28.4%), respectively. CONCLUSION The utilization of PGA sheets after ESD has an excellent outcome in reducing the risk of postoperative gastrointestinal bleeding and esophageal stricture.
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10.
Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial
Sattari SA, Shahoori A, Shahbazian H, Sabetnia L, Aref A, Sattari AR, Ghorbani A
Iranian journal of kidney diseases. 2022;16(4):238-245
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Free full text
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Editor's Choice
Abstract
INTRODUCTION Bleeding events are the most common complications after kidney biopsy. This study aims to evaluate the effect of desmopressin administration on bleeding complication, in native kidney biopsy candidates with reduced kidney function. METHODS This double-blind randomized clinical trial enrolled 18 to 80 years old patients with 15 < eGFR < 90 mL/min/ 1.73m² from July 2017 to August 2020. Patients were randomly assigned to receive either 3 µg/kg of intranasal desmopressin acetate or 1 mL/kg of intranasal sodium chloride 0.65%, one hour before ultrasound-guided, percutaneous native kidney biopsy. The primary outcome was the post-biopsy bleeding complications, and secondary outcomes were the volume of perirenal hematoma, and changes of post-biopsy hemoglobin and hematocrit level, plasma sodium and blood pressure (Clinical Trial Registration ID: IRCT20090701002112N3). RESULTS A total of 120 patients (58 men and 62 women), 60 patients in each group, were analyzed. The mean age and eGFR of the patients were 45.29 ± 15.95 years and 51.77 ± 18.02 ml/min/ 1.73m², respectively. Desmopressin administration significantly decreased post-biopsy perirenal hematoma compared to placebo (7/60 [11.6%]) vs. 33/60 [40%]; P < .05), and the hematoma volume was significantly smaller in the desmopressin group, in case of hematoma formation (2.31 ± 1.17 vs. 7.72 ± 5.45 mm³, P < .05). CONCLUSION Desmopressin administration before kidney biopsy is a safe and effective strategy to prevent bleeding complications. Considering absolute risk reduction of about 28%, the number needed to treat is about 4 procedures. We recommend considering desmopressin administration before percutaneous native kidney biopsy. DOI: 10.52547/ijkd.6966.
PICO Summary
Population
Adult patients with kidney disease, who were candidates for percutaneous native kidney biopsy (n= 120).
Intervention
Intranasal desmopressin acetate (n= 60).
Comparison
Placebo: intranasal sodium chloride (n= 60).
Outcome
Desmopressin administration significantly decreased post-biopsy perirenal haematoma compared to placebo (7/60 [11.6%]) vs. 33/60 [40%]), and the haematoma volume was significantly smaller in the desmopressin group, in case of haematoma formation (2.31 ± 1.17 vs. 7.72 ± 5.45 mm³).
