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
The American journal of gastroenterology. 2022
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.
Clinical Outcomes of Negative Balloon-Assisted Enteroscopy for Obscure Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Frontiers in medicine. 2022;9:772954
BACKGROUND For patients with obscure gastrointestinal bleeding (OGIB), finding the bleeding site is challenging. Balloon-assisted enteroscopy (BAE) has become the preferred diagnostic modality for OGIB. The long-term outcome of patients with negative BAE remains undefined. The present study aimed to evaluate the long-term outcomes of patients with negative BAE results for OGIB and to clarify the effect of further investigations at the time of rebleeding with a systematic review and meta-analysis of the available cohort studies. METHODS Studies were searched through the PubMed, EMBASE, and Cochrane library databases. The following indexes were analyzed: rebleeding rate after negative BAE, rebleeding rate after different follow-up periods, the proportion of patients who underwent further evaluation after rebleeding, the percentage of patients with identified rebleeding sources, and the percentage of patients with rebleeding sources in the small intestine. Heterogeneity was assessed using the I(2) test. RESULTS Twelve studies that involved a total of 407 patients were included in the analysis. The pooled rebleeding rate after negative BAE for OGIB was 29.1% (95% CI: 17.2-42.6%). Heterogeneity was significant among the studies (I(2) = 88%; p < 0.0001). The Chi-squared test did not show a difference in rebleeding rates between the short and long follow-up period groups (p = 0.142). The pooled proportion of patients who underwent further evaluation after rebleeding was 86.1%. Among the patients who underwent further evaluation, rebleeding sources were identified in 73.6% of patients, and 68.8% of the identified rebleeding lesions were in the small intestine. CONCLUSION A negative result of BAE in patients with OGIB indicates a subsequently low risk of rebleeding. Further evaluation should be considered after rebleeding.
Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery
Obesity surgery. 2022
PURPOSE Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery. MATERIALS AND METHODS Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia. RESULTS The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed. CONCLUSIONS In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.
A predictive model for blood transfusion during liver resection
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2022
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.
What is the optimal management of thromboprophylaxis after liver transplantation regarding prevention of bleeding, hepatic artery or portal vein thrombosis? A systematic review of the literature and expert panel recommendations
Clinical transplantation. 2022;:e14629
BACKGROUND A key tenet of clinical management of patients post liver transplantation (LT) is the prevention of thrombotic and bleeding complications. This systematic review investigated the optimal management of thromboprophylaxis after LT regarding portal vein thrombosis (PVT) or hepatic artery thrombosis (HAT) and prevention of bleeding. METHODS Systematic review following PRISMA guidelines and recommendations using the GRADE approach derived from an international expert panel. Seven databases were used to conduct extensive literature searches focusing on the use of anticoagulation in LT and its impact on the following outcomes: PVT, HAT, and bleeding. (CRD42021244288) RESULTS Of the 2,478 articles/abstracts screened, 16 studies were included in the final review. All articles were critically appraised by a panel of independent reviewers. There was wide variation regarding the anticoagulation protocols used. Thromboprophylaxis with therapeutic doses of heparin/Vitamin K antagonist combination did not decrease the risk of de novo or the recurrence of PVT but was associated with an increased risk of bleeding in some studies. Only the use of aspirin resulted in a small but significant decrease in the incidence of HAT post-LT, yet it did not increase the risk of bleeding. CONCLUSIONS Based on existing data and expert opinion, thromboprophylaxis at therapeutic or prophylactic dose is not recommended for prevention of de novo PVT following LT in patients not at high risk. Aspirin should be considered as the standard of care following LT to prevent HAT. Thromboprophylaxis should be strongly considered in recipients at risk of HAT and PVT following LT. This article is protected by copyright. All rights reserved.
Scheduled second look endoscopy after endoscopic hemostasis to patients with high risk bleeding peptic ulcers: a Randomized Controlled Trial
Surgical endoscopy. 2022
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.
A systematic review of post-pancreatectomy haemorrhage management stratified according to ISGPS grading
HPB : the official journal of the International Hepato Pancreato Biliary Association. 2021
BACKGROUND Morbidity and mortality from post-pancreatectomy haemorrhage (PPH) remains high. The International Study Group of Pancreatic Surgery (ISGPS) published guidelines to standardise definitions of PPH severity, management and reporting. This study aimed to i) identify the number of studies reporting PPH using ISGPS guidelines (Grade A, B or C) and ii) describe treatment modality success by grade. METHODS A systematic literature review was performed, identifying studies reporting PPH by ISGPS Grade and their subsequent management. RESULTS Of 62 studies reporting on PPH management, 17 (27.4%) stratified by ISGPS guidelines and included 608 incidences of PPH: 48 Grade A, 274 Grade B (62 early, 166 late, 46 unspecified) and 286 Grade C. 96% of Grade A PPH were treated conservatively. Of 62 early Grade B, 54.8% were managed conservatively and 37.1% surgically. Late Grade B were managed non-operatively in 25.3% (42/166), with successful endoscopy in 90.9% (10/11) and angiography in 90.3% (28/31). In Grade C, endoscopic treatment was successful in 64.4% (29/45) and angiography in 90.8% (108/119). Surgical intervention was required in 43.5% early Grade B, 7.8% late Grade B and 33.2% Grade C. CONCLUSION PPH grading is underreported and despite guidelines, inconsistencies remain when using definitions and reporting of outcomes.
Clinical usefulness of Red Dichromatic Imaging in hemostatic treatment during endoscopic submucosal dissection: first report from a multicenter, open-label, randomized controlled trial
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2021
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.
Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: A meta-analysis of randomized controlled trials
Vox sanguinis. 2021
BACKGROUND AND OBJECTIVES Due to rebalanced haemostasis in cirrhosis, viscoelastometric testing (VET) is more accurate than standard coagulation tests (SCTs) in preprocedural haemostatic evaluation, resulting in decreased unnecessary transfusion. We aimed to determine the impact of VET-guided strategy on postprocedural bleeding, periprocedural transfusion rates and quantities, transfusion-related adverse events (TRAEs), lengths of stay (LOS) and mortality from randomized controlled trials (RCTs) of cirrhotic patients. METHODS PubMed and EMBASE were searched for RCTs comparing VET-guided with SCT-guided transfusion in cirrhotic adults undergoing esophagogastroduodenoscopy, liver transplantation or other invasive interventions. Using random-effects models, the pooled risk ratios (RRs) and/or mean differences (MDs) of postprocedural bleeding-free events and the other outcomes were estimated alongside 95% confidence intervals (CIs). RESULTS Of seven included RCTs (n = 421; 72.2% men; mean age 49.1 years), VET-guided transfusion did not change postprocedural bleeding-free statuses (RR 1.05; 95% CI 0.94-1.17). However, VET-based algorithms decreased the rates of fresh frozen plasma (FFP; RR 0.52; 95% CI 0.35-0.77) and platelet transfusions (RR 0.34; 95% CI 0.16-0.73), the quantities of transfused FFP (MD -1.39 units; 95% CI -2.18 to -0.60), platelets (MD -1.06 units; 95% CI -2.01 to -0.12) and cryoprecipitate (MD -7.13 units; 95% CI -14.20 to -0.07) and the risk of TRAEs (RR 0.42; 95% CI 0.27-0.65). The overall mortality rates and LOS were not significantly different between two groups. CONCLUSION Compared with conventional SCT-guided, VET-guided strategy decreases periprocedural plasma and platelet transfusions and TRAEs, without increasing haemorrhagic complications, LOS or mortality in cirrhosis.
Patients with cirrhosis undergoing esophagogastroduodenoscopy, liver transplantation or other invasive interventions (7 studies, n= 421).
Viscoelastometric testing (VET) guided transfusion.
Standard coagulation testing (SCT) guided transfusion.
VET-guided transfusion did not change post-procedural bleeding-free statuses. However, VET-based algorithms decreased the rates of fresh frozen plasma (FFP) and platelet transfusions, the quantities of transfused FFP (MD -1.39 units), platelets (MD -1.06 units) and cryoprecipitate (MD -7.13 units) and the risk of transfusion-related adverse events. The overall mortality rates and lengths of stay were not significantly different between two groups.
Single-dose intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of post-operative anaemia in colorectal cancer patients: a randomised controlled trial
Blood transfusion = Trasfusione del sangue. 2021
BACKGROUND Recent clinical guidelines suggest that treatment of postoperative anaemia in colorectal cancer surgery with intravenous iron reduces transfusion requirements and improves outcomes. The study aimed at comparing two intravenous iron regimens in anaemic patients after colorectal cancer surgery. MATERIALS AND METHODS This was a single-centre, open-label, randomised, controlled trial in patients undergoing elective colorectal cancer surgery. Patients with moderate to severe anaemia (haemoglobin [Hb] <11 g/dL) after surgery were randomly assigned 1:1 to receive ferric carboxymaltose (FC; 1,000 mg, single dose) or iron sucrose (IS; 200 mg every 48 hours until covering the total iron deficit or discharge). Randomisation was stratified by Hb level: <10 g/dL (Group A) or ≥10-10.9 (Group B). The primary endpoint was the change in Hb concentration at postoperative day 30. Secondary endpoints included iron status parameters, transfusion requirements, complications, and length of hospital stay. RESULTS From September 2015 to May 2018, 104 patients were randomised (FC 50, IS 54). The median intravenous iron dose was 1,000 mg and 600 mg in the FC and IS groups, respectively. There were no between-group differences in mean change in Hb from postoperative day 1 to postoperative day 30 (FC: 2.5 g/dL, 95% CI: 2.1-2.9; IS: 2.4 g/dL, 95% CI: 2.0-2.8; p=0.52), in transfusion requirements or length of stay. The infection rate was lower in the FC group compared with the IS group (9.8% vs 37.2%, respectively). DISCUSSION The administration of approximately 500 mg of IS resulted in an increase in Hb at postoperative day 30 similar to that of 1,000 mg of FC, but it was associated with a higher infection rate. Future research will be needed to confirm the results, and to choose the best regime in terms of effectiveness and side effects to treat postoperative anaemia in colorectal cancer patients.