Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial
Gastrointestinal endoscopy. 2021
BACKGROUND AND AIMS Prophylactic application of a hemoclip has been suggested as an alternative to the use of an endoloop for the prevention of postpolypectomy bleeding (PPB) when resecting large, pedunculated colorectal polyps. Therefore, this multicenter, randomized controlled trial investigated the efficacy of prophylactic hemoclip application to reduce PPB during the resection of large pedunculated polyps. METHODS Large pedunculated polyps (≥10 mm in head diameter) were eligible for inclusion. Polyps were randomized into a study arm (where clips were applied before resection) and a control arm (without pretreatment). The primary outcome was the rate of PPB in each group. PPB included immediate PPB (IPPB) and delayed PPB (DPPB). IPPB was defined as blood oozing (≥1 min) or active spurting occurring immediately after polyp resection. DPPB was defined as rectal bleeding, occurring after completion of the colonoscopy. RESULTS In total, 238 polyps from 204 patients were randomized into the clip arm (119 polyps) or the control arm (119 polyps). Overall bleeding adverse events were observed in 20 cases (IPPB, n=16; DPPB, n=4). The rate of overall PPB, IPPB and DPPB was 8.4%, 6.7%, and 1.7%, respectively, for all polyps. The rate of overall PPB (clip 4.2% vs control 12.6%, P=0.033) and IPPB (clip 2.5% vs control 10.9%, P=0.017) was significantly lower in the clip arm than the control arm. CONCLUSIONS Prophylactic clipping before resecting large pedunculated polyps can reduce overall PPB and IPPB compared with no prior treatment. Therefore, prophylactic clipping may be considered before resection of large pedunculated polyps. (ClinicalTrials.gov: NCT02156193).
The Effect of Perioperative Blood Transfusion on Long-Term Survival Outcomes After Surgery for Pancreatic Ductal Adenocarcinoma: A Systematic Review
OBJECTIVE To evaluate survival outcomes associated with perioperative allogeneic red blood cell transfusion (RBCT) in patients with pancreatic ductal adenocarcinoma undergoing surgery. METHODS PubMed, Embase, Cochrane, and Web of Science Core Collection were queried for English-language articles until May 28, 2020. Studies evaluating long-term outcomes of RBCT compared with no transfusion in adults with pancreatic ductal adenocarcinoma undergoing pancreatectomy were included. E-value sensitivity analysis assessed the potential for unmeasured confounders to overcome these findings. RESULTS Of 4379 citations, 5 retrospective cohort studies were included. Three studies reported shorter recurrence-free survival by 1 to 5 months with RBCT. Two studies found shorter disease-specific survival by 5 to 13 months with RBCT. Overall survival was reduced by 5 to 7 months with RBCT in 3 studies. All multivariable findings associated with RBCT could be readily overcome unmeasured confounding on sensitivity analysis. Confounding in baseline characteristics resulted in high risk of bias. CONCLUSIONS Imprecision, unmeasured confounding, small effect sizes, and overall low quality of the available literature result in uncertainty regarding the effect of transfusion on recurrence-free survival, disease-specific survival, and overall survival in patients undergoing surgery for pancreatic cancer. Randomized trials are needed to determine if there is a causal relationship between transfusion and survival after pancreatic resection.
Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;136:111251
BACKGROUND Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding. METHODS This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%. RESULTS 526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005). CONCLUSION The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.
Intravenous iron supplementation after liver surgery: Impact on anemia, iron, and hepcidin levels-a randomized controlled trial
BACKGROUND Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery. METHODS The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery. RESULTS The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups. CONCLUSION Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.
Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2021
Background: There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Methods: Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Results: Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Conclusion: Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).
Rituximab or plasmapheresis for prevention of recurrent focal segmental glomerulosclerosis after kidney transplantation: A systematic review and meta-analysis
World journal of transplantation. 2021;11(7):303-319
BACKGROUND Focal segmental glomerulosclerosis (FSGS) is one of the most common glomerular diseases leading to renal failure. FSGS has a high risk of recurrence after kidney transplantation. Prevention of recurrent FSGS using rituximab and/or plasmapheresis has been evaluated in multiple small studies with conflicting results. AIM: To assess the risk of recurrence of FSGS after transplantation using prophylactic rituximab with or without plasmapheresis, and plasmapheresis alone compared to the standard treatment group without preventive therapy. METHODS This meta-analysis and systematic review were performed by first conducting a literature search of the MEDLINE, EMBASE, and Cochrane databases, from inception through March 2021; search terms included 'FSGS,' 'steroid-resistant nephrotic syndrome', 'rituximab,' and 'plasmapheresis,'. We identified studies that assessed the risk of post-transplant FSGS after use of rituximab with or without plasmapheresis, or plasmapheresis alone. Inclusion criteria were: Original, published, randomized controlled trials or cohort studies (either prospective or retrospective), case-control, or cross-sectional studies; inclusion of odds ratio, relative risk, and standardized incidence ratio with 95% confidence intervals (CI), or sufficient raw data to calculate these ratios; and subjects without interventions (controls) being used as comparators in cohort and cross-sectional studies. Effect estimates from individual studies were extracted and combined using a random effects model. RESULTS Eleven studies, with a total of 399 kidney transplant recipients with FSGS, evaluated the use of rituximab with or without plasmapheresis; thirteen studies, with a total of 571 kidney transplant recipients with FSGS, evaluated plasmapheresis alone. Post-transplant FSGS recurred relatively early. There was no significant difference in recurrence between the group that received rituximab (with or without plasmapheresis) and the standard treatment group, with a pooled risk ratio of 0.82 (95%CI: 0.47-1.45, I (2) = 65%). Similarly, plasmapheresis alone was not associated with any significant difference in FSGS recurrence when compared with no plasmapheresis; the pooled risk ratio was 0.85 (95%CI: 0.60-1.21, I (2) = 23%). Subgroup analyses in the pediatric and adult groups did not yield a significant difference in recurrence risk. We also reviewed and analyzed post-transplant outcomes including timing of recurrence and graft survival. CONCLUSION Overall, the use of rituximab with or without plasmapheresis, or plasmapheresis alone, is not associated with a lower risk of FSGS recurrence after kidney transplantation. Future studies are required to assess the effectiveness of rituximab with or without plasmapheresis among specific patient subgroups with high-risk for FSGS recurrence.
The role of clips in preventing delayed bleeding after colorectal polyp resection: an individual patient data meta-analysis
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2021
BACKGROUND & AIMS Non-pedunculated colorectal polyps are normally endoscopically removed to prevent neoplastic progression. Delayed bleeding is the most common major adverse event. Clipping the resection defect has been suggested to reduce delayed bleedings. Our aim was to determine if prophylactic clipping reduces delayed bleedings and to analyze the contribution of polyp characteristics, extent of defect closure and antithrombotic use. METHODS An Individual Patient Data Meta-Analysis was performed. Studies on prophylactic clipping in non-pedunculated colorectal polyps were selected from PubMed, Embase, Web of Science and Cochrane database (last selection: April 2020). Authors were invited to share original study data. The primary outcome was delayed bleeding ≤30 days. Multivariable mixed models were used to determine the efficacy of prophylactic clipping in various subgroups adjusted for confounders. RESULTS Data of 5,380 patients with 8,948 resected polyps were included from three RCT's, two prospective and eight retrospective studies. Prophylactic clipping reduced delayed bleeding in proximal polyps ≥20 mm (OR 0.62; 95% CI 0.44 - 0.88; Number Needed to Treat [NNT] = 32), especially with antithrombotics (OR 0.59; 95% CI 0.35 - 0.99; NNT = 23; subgroup of anticoagulants/double platelet inhibitors N=226; OR 0.40; 95% CI 0.16 - 1.01; NNT = 12). Prophylactic clipping did not benefit distal polyps ≥20 mm with antithrombotics (OR 1.41; 95% CI 0.79 - 2.52). CONCLUSIONS Prophylactic clipping reduces delayed bleeding after resection of non-pedunculated, proximal colorectal polyps ≥20 mm, especially in patients using antithrombotics. No benefit was found for distal polyps. Based on this study, patients can be identified who may benefit from prophylactic clipping. (PROSPERO registration number CRD42020104317).
Prophylactic transcatheter arterial embolization for high-risk ulcers following endoscopic hemostasis: a meta-analysis
World journal of emergency surgery : WJES. 2021;16(1):29
BACKGROUND To conduct a meta-analysis to assess the safety and efficacy of prophylactic transcatheter arterial embolization (PTAE) for the treatment of high-risk bleeding peptic ulcers after achieving endoscopic hemostasis. METHODS PubMed and Cochrane Library were queried for full-text articles published up to December 2019. The following keywords were used: "prophylactic embolization", "supplement embolization", "gastrointestinal bleeding", and "ulcer bleeding". High-risk ulcers were defined based on endoscopic findings (i.e., large ulcers, Forrest class I-IIb) and/or clinical presentation (i.e., hypotension, decreased hemoglobin during endoscopy). Only comparative studies investigating PTAE versus conservative treatment after achieving endoscopic hemostasis were included. Baseline study characteristics, rebleeding rate, need for surgery, mortality, and PTAE-related complication rates were investigated. Quantitative analyses were performed with Stata 15.1. RESULTS Among the five included original studies, a total of 265 patients received PTAE and 617 were managed conservatively after endoscopy. The rebleeding rate (6.8% vs 14.3%, p = 0.003) and mortality (4.5% vs 8.8%, p = 0.032) of patients from the PTAE group were lower than the control group. PTAE also reduced the cumulative need for future surgical intervention (3.0% vs 14.4%, p = 0.005). The PTAE-related major and minor events were 0.75% and 14.4%, respectively. CONCLUSION PTAE had therapeutic potentials in reducing rebleeding risk, need for surgical intervention, and morality in high-risk peptic ulcers after achieving endoscopic hemostasis. The embolization-associated adverse events were minimal. Future studies should aim to increase the sample size and resources for performing endovascular interventions.
Empiric Transcatheter Embolization for Acute Arterial Upper Gastrointestinal Bleeding: A Meta-Analysis
AJR. American journal of roentgenology. 2021;:1-14
OBJECTIVE. The purpose of this study was to conduct a meta-analysis to assess the safety and efficacy of empiric embolization compared with targeted embolization in the treatment of acute upper gastrointestinal bleeding (UGIB). MATERIALS AND METHODS. We searched the PubMed and Cochrane Library databases for studies performed without language restrictions from January 2000 to November 2019. Only clinical studies with a sample size of five or more were included. Clinical success, rebleeding and complication rates, survival rates, bleeding cause, embolic materials, and vessels embolized were recorded. Empiric embolization and targeted embolization (i.e., embolization performed based on angiographic evidence of ongoing bleeding) were compared when possible. Meta-analysis was performed. RESULTS. Among 13 included studies (12 retrospective and 1 prospective), a total of 357 of 725 patients (49.2%) underwent empiric embolization for UGIB. The clinical success rate of empiric embolization was 74.7% (95% CI, 63.1-86.3%) among the 13 studies, and the survival rate was 80.9% (95% CI, 73.8-88.0%) for 10 studies. On the basis of comparative studies, no statistically significant difference was observed between empiric and targeted embolization in terms of rebleeding rate in 111 studies (36.5% vs 29.6%; odds ratio [OR], 1.13; 95% CI, 0.77-1.65; p = .53), mortality in eight studies (23.3% vs 18.0%; OR, 1.44; 95% CI, 0.89-2.33; p = .14), and need for surgery to control rebleeding in four studies (17.8% vs 13.4%; OR, 1.34; 95% CI, 0.58-3.07; p = .49). The pooled embolization-specific complications were 1.9% (empiric) and 2.4% (targeted). CONCLUSION. According to all available published evidence, empiric embolization assessed with endoscopic or preprocedural imaging findings (or both) appears to be as effective as targeted embolization in preventing rebleeding and mortality in patients with angiographically negative acute UGIB. Because of its favorable safety profile, empiric embolization should be considered for patients in this clinical scenario.
Safety, Efficacy, and Outcomes of N-Butyl Cyanoacrylate Glue Injection through the Endoscopic or Radiologic Route for Variceal Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Journal of clinical medicine. 2021;10(11)
We performed a systematic review and meta-analysis of published studies to assess the efficacy, safety, and outcomes of N-butyl cyanoacrylate (NBCA) injection for the treatment of variceal gastrointestinal bleeding (GIB). The MEDLINE/PubMed, EMBASE, and SCOPUS databases were searched for English-language studies published from January 1980 to December 2019 and including patients who had injection of NBCA for variceal GIB. Two independent reviewers extracted and evaluated the data from eligible studies. Exclusion criteria were sample size < 5, article reporting the use of NBCA with other embolic agents, no extractable data, and duplicate reports. NBCA was injected during endoscopy in 42 studies and through a direct percutaneous approach for stomal varices in 1 study. The study's endpoints were: Technical success, 30-day rebleeding, and 30-day overall and major complications. The estimated overall rates were computed with 95% confidence intervals, based on each study rate, weighted by the number of patients involved in each study. In total, 43 studies with 3484 patients were included. The technical success rate was 94.1% (95% CI: 91.6-96.1%), the 30-day rebleeding rate was 24.2% (18.9-29.9%), and 30-day overall and major complications occurred in 15.9% (11.2-21.3%) and 5.3% (3.3-7.8%) of patients, respectively. For treating variceal GIB, NBCA injection is a safe and effective method that demonstrates high technical success rate and very low major complication rate.