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Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial
Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, et al
The American journal of gastroenterology. 2022
Abstract
INTRODUCTION The aim of our study was to compare clear liquid diet with 2 different polyethylene glycol (PEG)-based bowel preparation methods regarding diagnostic yield of small bowel capsule endoscopy (SBCE) in patients with suspected small bowel bleeding (SBB). METHODS In this prospective multicenter randomized controlled trial, consecutive patients undergoing SBCE for suspected SBB between September 2010 and February 2016 were considered. Patients were randomly assigned to standard regimen, that is, clear fluids only (prep 1), standard regimen plus 500 mL PEG after SBCE ingestion (prep 2), or standard regimen plus 2 L PEG plus 500 mL PEG after SBCE ingestion (prep 3). The primary outcome was the detection of at least one clinically significant lesion in the small bowel. The quality of small bowel cleansing was assessed. A questionnaire on the clinical tolerance was filled by the patients. RESULTS We analyzed 834 patients. No significant difference was observed for detection of P1 or P2 small bowel lesions between prep1 group (40.5%), prep 2 group (40.2%), and prep 3 group (38.5%). Small bowel cleansing was improved in prep 2 and 3 groups compared with that in prep 1 group. Compliance to the preparation and tolerance was better in prep 2 group than in prep 3 group. DISCUSSION Small bowel purgative before SBCE allowed better quality of cleansing. However, it did not improve diagnostic yield of SBCE for suspected SBB.
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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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A predictive model for blood transfusion during liver resection
Cao B, Hao P, Guo W, Ye X, Li Q, Su X, Li L, Zeng J
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2022
Abstract
BACKGROUND A predictive model that can identify patients who are at increased risk of intraoperative blood transfusion could guide preoperative transfusion risk counseling, optimize health care resources, and reduce medical costs. Although previous studies have identified some predictors for particular populations, there is currently no existing model that uses preoperative variables to accurately predict blood transfusion during surgery, which could help anesthesiologists optimize intraoperative anesthetic management. METHODS We collected data from 582 patients who underwent elective liver resection at a university-affiliated tertiary hospital between January 1, 2018, and December 31, 2020. The data set was then randomly divided into a training set (n = 410) and a validation set (n = 172) at a 7:3 ratio. The least absolute shrinkage and selection operating regression model was used to select the optimal feature, and multivariate logistic regression analysis was applied to construct the transfusion risk model. The concordance index (C-index) and the area under the receiver operating characteristic (ROC) curve (AUC) were used to evaluate the discrimination ability, and the calibration ability was assessed with calibration curves. In addition, we used decision curve analysis (DCA) to estimate the clinical application value. For external validation, the test set data were employed. RESULTS The final model had 8 predictor variables for intraoperative blood transfusion, which included the following: preoperative hemoglobin level, preoperative prothrombin time >14 s, preoperative total bilirubin >21 μmol/L, respiratory diseases, cirrhosis, maximum lesion diameter >5 cm, macrovascular invasion, and previous abdominal surgery. The model showed a C-index of 0.834 (95% confidence interval, 0.789-0.879) for the training set and 0.831 (95% confidence interval, 0.766-0.896) for the validation set. The AUCs were 0.834 and 0.831 for the training and validation sets, respectively. The calibration curve showed that our model had good consistency between the predictions and observations. The DCA demonstrated that the transfusion nomogram was reliable for clinical applications when an intervention was decided at the possible threshold across 1%-99% for the training set. CONCLUSION We developed a predictive model with excellent accuracy and discrimination ability that can help identify those patients at higher odds of intraoperative blood transfusion. This tool may help guide preoperative counseling regarding transfusion risk, optimize health care resources, reduce medical costs, and optimize anesthetic management during surgery.
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Clinical usefulness of Red Dichromatic Imaging in hemostatic treatment during endoscopic submucosal dissection: first report from a multicenter, open-label, randomized controlled trial
Fujimoto A, Saito Y, Abe S, Hoteya S, Nomura K, Yasuda H, Matsuo Y, Uraoka T, Kuribayashi S, Tsuji Y, et al
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2021
Abstract
OBJECTIVES To verify the efficacy and safety of Red Dichromatic Imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD). METHODS This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n=204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n=200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non-inferior perforation rate, in RDI versus WLI. RESULTS The mean hemostasis time in RDI (n=860) was not significantly shorter than that in WLI (n=1049) (62.3±108.1 versus 56.2±74.6 seconds; p=0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 (18.0-71.0) versus 28.0 (14.0-66.0) seconds; p=0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71±0.935 versus 2.03±1.038; p<0.001). There was no significant difference in the ESD treatment time between RDI (n=161) and WLI (n=168) (58.0 (35.0-86.0) versus 60.0 (38.0-88.5) minutes; p=0.855). Four perforations were observed, but none of them took place during the hemostatic treatment. CONCLUSIONS Hemostatic treatment using RDI does not shorten the hemostasis time. RDI, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during ESD. UMIN000025134.
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Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment
Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F
Vox Sanguinis. 2017;112((8):):788-795
Abstract
BACKGROUND Thromboelastometry may reduce red blood cell (RBC) transfusion in liver transplantation (LT). Fibrinogen concentration is a primary determinant of FIBTEM maximum clot firmness (MCF), but several factors could affect the correlation between FIBTEM MCF and fibrinogen values. We aimed to investigate (1) the concordance between fibrinogen level and FIBTEM MCF and (2) the association of fibrinogen level and FIBTEM MCF with RBC transfusion during LT. METHODS A post hoc analysis of data from a randomized, multicentre, double-blind, saline/fibrinogen trial was used (NCT01539057). A total of 86 adult patients were included. RESULTS The Lin concordance coefficient (LCC) between FIBTEM MCF and fibrinogen levels with the model formula 1.3679 + 0.05414* FIBTEM MCF was poor overall (LLC [95% CI]: 0.387 [0.340 to 0.432]) and moderate for the preperfusion period (LLC [95% CI]: 0.789 [0.747 to 0.824]), but very poor for the postreperfusion period (LLC [95% CI] 0.170 [0.105 to 0.233]). The model assessed for RBC transfusion for FIBTEM MCF showed an area under the curve of 0.788 [0.745-0.832]. Patients with FIBTEM MCF values <8 mm had a significantly higher likelihood of receiving RBC than patients with higher values. (OR [95% CI]: 2.08 [1.30-3.33], P = 0.002). FIBTEM MCF values over 10 mm do not appear to reduce the likelihood of RBC transfusion. CONCLUSION FIBTEM MCF is not a good indicator of plasma fibrinogen values after graft reperfusion. FIBTEM MCF >8 mm during the LT procedure is associated with less RBC transfusion. FIBTEM MCF values over 10 mm could lead to unnecessary fibrinogen administration.
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Thrombelastography-guided blood product use before invasive procedures in cirrhosis with severe coagulopathy: a randomized, controlled trial
De Pietri L, Bianchini M, Montalti R, De Maria N, Di Maira T, Begliomini B, Gerunda GE, di Benedetto F, Garcia-Tsao G, Villa E
Hepatology. 2016;63((2)):566-73.
Abstract
UNLABELLED Bleeding is a feared complication of invasive procedures in patients with cirrhosis and significant coagulopathy (as defined by routine coagulation tests) and is used to justify preprocedure use of fresh frozen plasma (FFP) and/or platelets (PLT). Thromboelastography (TEG) provides a more comprehensive global coagulation assessment than routine tests (international normalized ratio [INR] and platelet count), and its use may avoid unnecessary blood product transfusion in patients with cirrhosis and significant coagulopathy (defined in this study as INR >1.8 and/or platelet count <50 x 10(9) /L) who will be undergoing an invasive procedure. Sixty patients were randomly allocated to TEG-guided transfusion strategy or standard of care (SOC; 1:1 TEG:SOC). The TEG group would receive FFP if the reaction time (r) was >40 min and/or PLT if maximum amplitude (MA) was <30 mm. All SOC patients received FFP and/or PLT per hospital guidelines. Endpoints were blood product use and bleeding complications. Baseline characteristics of the two groups were similar. Per protocol, all subjects in the SOC group received blood product transfusions versus 5 in the TEG group (100% vs. 16.7%; P<0.0001). Sixteen SOC (53.3%) received FFP, 10 (33.3%) PLT, and 4 (13.3%) both FFP and PLT. In the TEG group, none received FFP alone (P<0.0001 vs. SOC), 2 received PLT (6.7%; P=0.009 vs. SOC), and 3 both FFP and PLT (not significant). Postprocedure bleeding occurred in only 1 patient (SOC group) after large-volume paracentesis. CONCLUSIONS In patients with cirrhosis and significant coagulopathy before invasive procedures, TEG-guided transfusion strategy leads to a significantly lower use of blood products compared to SOC (transfusion guided by INR and platelet count), without an increase in bleeding complications. Remarkably, even in patients with significant coagulopathy, postprocedure bleeding was rare, indicating that TEG thresholds should be reevaluated. (Hepatology 2016;63:566-573).Copyright © 2015 by the American Association for the Study of Liver Diseases.
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Selecting patients for acute normovolemic hemodilution during hepatic resection: A prospective randomized evaluation of nomogram-based allocation
Frankel TL, Fischer M, Grant F, Krone J, D'Angelica MI, Dematteo RP, Jarnagin WR, Gonen M
Journal of the American College of Surgeons. 2013;217((2):):210-20.
Abstract
BACKGROUND Acute normovolemic hemodilution (ANH) decreases transfusion rates but adds to the complexity of anesthetic management during hepatectomy. A randomized controlled trial was conducted to determine if selecting patients for ANH using a transfusion nomogram improves management and resource use compared with selection using extent of resection. STUDY DESIGN One hundred fourteen patients undergoing partial hepatectomy were randomized to a clinical arm (ANH used for resection of >=3 liver segments) or a nomogram arm (ANH used for predicted probability of transfusion >=50% based on a previously validated nomogram). The primary end point was appropriate management, defined as avoidance of ANH in patients at low risk or use of ANH in patients at high risk for allogeneic red blood cell transfusions. RESULTS Between September 2009 and May 2011, 58 patients were randomized to the clinical arm and 56 to the nomogram arm. Demographics, diagnoses, extent of resection, blood loss, and incidence and grade of complications did not differ between the 2 groups. There were no differences in perioperative transfusions or laboratory values. Nomogram-based allocation did not change appropriate management overall (80% vs 76% in the clinical arm; p=0.65), but did result in comparable perioperative outcomes and a trend toward decreased ANH use (30% vs 47%; p= 0.09), particularly in low blood loss (estimated blood loss <=400mL) cases (12% vs 25%; p= 0.04). CONCLUSIONS Although allocation of intraoperative management using a transfusion nomogram did not improve appropriate management overall, it more effectively identified low blood loss cases and reduced ANH use in patients least likely to benefit. Copyright 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.
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Evaluation of hemostatic factors in patients undergoing major hepatic resection and other major abdominal surgeries
Tapper EB, Tanaka KA, Sarmiento JM
The American Surgeon. 2011;77((9):):1188-93.
Abstract
The aim of this study was to evaluate the role for additional testing of coagulation in perioperative management of patients undergoing major hepatic resection. Major outcome measures were perioperative measurements of hemostatic factors (activated partial prothrombin time [aPTT], prothrombin time/international normalized ratio, fibrinogen, antithrombin-III). We conducted a prospective, single-blind study comparing hemostatic factors in patients undergoing major hepatectomy, Whipple procedures, and other gastrointestinal operations. Ninety-five consecutive patients were enrolled. No values differed significantly at baseline. Immediately postoperative, only international normalized ratio was significantly lower comparing major hepatectomy with Whipple (P < 0.005) and other procedures (P < 0.0032). Twenty-four hours postoperative, antithrombin-III was lower for major hepatectomy than Whipple (P < 0.028) and others (P < 0.0001); fibrinogen was lower compared with Whipple (P < 0.014) and others (P < 0.0009); international normalized ratio was lower to compared with Whipple (P < 0.0001) and others (P < 0.0001). aPTT measurements never differed significantly between groups at any time. Antithrombin-III and fibrinogen only correlated with international normalized ratio and aPTT for the other procedures. Additional hemostatic values beyond the standard evaluations of aPTT and international normalized ratio are needed to better assess patients undergoing major hepatic surgery.
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Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial
Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY
Transplantation Proceedings. 2010;42((7):):2590-3.
Abstract
OBJECTIVE To test in a prospective randomized study the hypothesis that use of thromboelastography (TEG) decreases blood transfusion during major surgery. MATERIAL AND METHODS Twenty-eight patients undergoing orthotopic liver transplantation were recruited over 2 years. Patients were randomized into 2 groups: those monitored during surgery using point-of-care TEG analysis, and those monitored using standard laboratory measures of blood coagulation. Specific trigger points for transfusion were established in each group. RESULTS In patients monitored via TEG, significantly less fresh-frozen plasma was used (mean [SD], 12. 8 [7. 0] units vs 21. 5 [12. 7] units). There was a trend toward less blood loss in the TEG-monitored patients; however, the difference was not significant. There were no differences in total fluid administration and 3-year survival. CONCLUSION Thromboelastography-guided transfusion decreases transfusion of fresh- frozen plasma in patients undergoing orthotopic liver transplantation, but does not affect 3-year survival.