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1.
Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial
Park SW, Song TJ, Park JS, Jun JH, Park TY, Oh DW, Lee SS, Kim MH
Endoscopy. 2022
Abstract
BACKGROUND : Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy. METHODS : Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding. RESULTS : The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1-47.5] vs. 15.0 % [95 %CI 7.1-29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7-31.9] vs. 5.3 % [95 %CI 1.5-17.3]), and all cases were mild. CONCLUSIONS : Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.
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2.
The Role of the Endoscopic Doppler Probe in Non-Variceal Upper Gastrointestinal Bleeding: a systematic review and meta-analysis
Chapelle N, Martel M, Bardou M, Almadi M, Barkun AN
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2022
Abstract
INTRODUCTION The effectiveness of the Doppler Endoscopic Probe (DEP) remains unclear in non-variceal upper gastrointestinal bleeding (NVUGIB). We thus performed a systematic review characterizing the effectiveness of DEP in patients with NVUGIB addressing this question. METHODS A literature search was done until July 2021 using MEDLINE, EMBASE, and ISI Web of Science. A series of meta-analyses were performed assessing outcomes amongst observational and interventional studies for DEP signal positive and negative lesions as well as DEP-assisted versus standard endoscopies. The primary outcome was "overall rebleeding"; secondary outcomes included all-cause mortality, bleeding-related mortality, need for surgery, length of stay, ICU stay and angiography. RESULTS Fourteen studies were included from 1911 citations identified: Observational studies compared bleeding lesions with DEP positive versus DEP negative signals (11 studies n=800 pre-hemostasis, and n=148 with post-hemostasis data from 5 studies). Three interventional studies (n=308) compared DEP-assisted to standard endoscopy management. DEP signal positive versus negative lesions both prior to or following any possible hemostasis were at greater risk of overall rebleeding (OR=6.54 (2.36; 18.11, and OR=25.96; (6.74; 100.0), respectively). The use of DEP during upper endoscopy significantly reduced overall rebleeding rates (OR=0.27 (0.14; 0.54). When removing outcomes analysis for which only one study was available, all evaluable outcomes were improved with DEP characterization of management guidance except for all-cause mortality. DISCUSSION Although low certainty evidence, DEP-related information improves on sole visual prediction of rebleeding in NVUGIB, with DEP-guided management yielding decreased overall rebleeding, bleeding-related mortality and need for surgery.
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Timing of intraoperative crystalloid infusion may decrease total volume of infusate without affecting early graft function in live related renal transplant surgery: A randomized, surgeon-blinded clinical study
Singh A, Ramachandran R, Chandralekha C, Trikha A, Ray BR, Bansal VK, Mahajan S, Asuri K, Rewari V
Indian journal of urology : IJU : journal of the Urological Society of India. 2022;38(1):53-61
Abstract
INTRODUCTION Early graft function is crucial for successful kidney transplantation. Intravascular volume maintenance is paramount in ensuring reperfusion of transplanted kidney. This study was planned to compare whether the timing of fluid infusion can help to decrease amount of fluid given without altering early graft function during renal transplantation. MATERIALS AND METHODS The present study included forty recipients, randomized into standard (Group-S) or targeted fluid therapy (Group-T). Group S received fluid according to conventional fasting deficit while Group T received at 1 ml/kg/h from the start of surgery till start of vascular anastomosis after which fluid infusion rate in both group was increased to maintain a central venous pressure of 13-15 mm of Hg till reperfusion. Primary outcome measured was serum creatinine level on first postoperative day while secondary outcomes were IV fluid given, perioperative hemodynamics, onset of diuresis, graft turgidity, urine output, and renal function during first 6 postoperative days. RESULTS The study showed Group T postoperatively had early fall in serum creatinine (day 3) than S (day 6) although this difference was not statistically significant. Group T had received significantly less fluid per kg of dry weight (T-42.7 ± 9.7 ml/kg, S-61.1 ± 11.1 ml/kg, P < 0.001), had early diuresis, better graft turgidity and urine output than Group S. CONCLUSION Targeted hydration significantly decreases the total amount of fluid infused during the intraoperative period without altering early graft function. Targeted hydration during vascular anastomosis produced stable hemodynamics and early diuresis without any side-effects pertaining to hypo or hyper-volemia.Clinical trial identifier number-CTRI/2016/07/007111.
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4.
Regional vessels wrapping following pancreaticoduodenectomy reduces the risk of post-operative extra-luminal bleeding. A systematic review
Nour HM, Peristeri DV, Ahsan A, Shafique S, Khan PM, Sajid MS
Annals of medicine and surgery (2012). 2022;82:104618
Abstract
BACKGROUND Post-pancreatectomy bleeding is a potentially fatal complication which results from the erosion of the regional visceral arteries, mainly the hepatic artery and stump of the gastro-duodenal artery, caused by a leak or fistula from the pancreatic anastomosis. The objective of this article is to assess whether wrapping of regional vessels with omentum or falciform/teres ligament following pancreaticoduodenectomy reduces the risk of extra-luminal bleeding. MATERIALS AND METHOD Standard medical electronic databases were searched with the help of a local librarian and relevant published randomised controlled trials (RCT) and any type of comparative trial were shortlisted according to the inclusion criteria. The summated outcome of post-operative extra-luminal bleeding in patients undergoing pancreaticoduodenectomy was evaluated using the principles of meta-analysis on RevMan 5 statistical software. RESULT Two RCTs and 5 retrospective studies on 4100 patients undergoing pancreaticoduodenectomy were found suitable for this meta-analysis. There were 1404 patients in the wrapping-group (WG) and 2696 patients in the no-wrapping group (NWG). In the random effects model analysis, the incidence of extra-luminal haemorrhage was statistically lower in WG [odds ratio 0.51, 95%, CI (0.31, 0.85), Z = 2.59, P = 0.01]. There was moderate heterogeneity between the studies; however it was not statistically significant. CONCLUSION The wrapping of regional vessels (using omentum, falciform ligament or ligamentum teres) following pancreaticoduodenectomy seems to reduce the risk of post-operative extra-luminal bleeding. However, more RCTs of robust quality recruiting a greater number of patients are required to validate these findings as this study presents the combined data of two RCTs and 5 retrospective studies.
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5.
Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases
Zhou Y, Zeng J, Song L, Wang C
Journal of clinical pharmacy and therapeutics. 2022
Abstract
WHAT IS KNOWN AND OBJECTIVE The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS We searched Chinese and English databases to collect case reports of terlipressin-induced skin necrosis for retrospective analysis. RESULTS AND DISCUSSION A total of 42 patients (31 males and 11 females) from 35 studies were included, with a median age of 54 years (range 0.17-84). The onset of skin ischemia ranged from a few hours to 21 days. The most common clinical manifestations were bulla (15 cases, 35.7%), cyanosis (12 cases, 28.6%), necrosis (11 cases, 26.2%), and purpura (10 cases, 23.8%). The following were often affected: the legs (26 cases), 61.9%), abdomen (13, 31.0%), scrotum (10 cases, 23.8%), feet (10 cases, 23.8%), upper extremities (8 cases, 19.0%), and hands (7 cases, 16.7%). Skin biopsy showed fibrin thrombus (7 cases, 38.9%), nonspecific inflammation (6 cases, 33.3%), and necrosis (10 cases, 55.6%). After discontinuation of terlipressin, skin symptoms improved in most patients. WHAT IS NEW AND CONCLUSION Ischemic skin necrosis is a rare and serious adverse effect of terlipressin. Patients receiving terlipressin therapy should be monitored closely for terlipressin-related ischemic complications. Terlipressin should be discontinued immediately if ischemic complications occur.
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6.
Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial
Ishii K, Yokoyama Y, Yonekawa Y, Hayashi D, Kinoshita F, Kuwatsuka Y, Okuno M, Natsume S, Minami T, Sugawara G, et al
The British journal of surgery. 2022
Abstract
BACKGROUND Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). METHODS A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. RESULTS Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference -42 ml, 95 per cent c.i. -191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference -77 ml, 95 per cent c.i. -226 to 72). The secondary outcomes were comparable between the two groups. CONCLUSION Perioperative TXA use did not reduce blood loss during PD. REGISTRATION NUMBER jRCTs041190062 (https://jrct.niph.go.jp).
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7.
Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)
Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, et al
Gut. 2022
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Editor's Choice
Abstract
OBJECTIVE Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients. DESIGN We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding. RESULTS 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362). CONCLUSION OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis. TRIAL REGISTRATION NUMBER NCT03331224.
PICO Summary
Population
High-risk patients with acute non-variceal upper gastrointestinal bleeding enrolled in the STING-2 trial (n= 100).
Intervention
First-line over-the-scope-clips therapy (OTSC group, n= 48).
Comparison
Standard endoscopic treatment (ST group, n= 52).
Outcome
Clinical success was 91.7% (44 patients) in the OTSC group compared with 73.1% (38 patients) in the ST group. Persistent bleeding occurred in 11.5% (6 patients) in the ST group, vs. zero patients in the OTSC group. Recurrent bleeding was observed in 8.3% (4 patients) in the OTSC group and in 15.4% (8 patients) in the ST group.
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8.
Intravenous Tranexamic Acid in Percutaneous Kidney Biopsy: A Randomized Controlled Trial
Izawa J, Matsuzaki K, Raita Y, Uehara G, Nishioka N, Yano H, Sudo K, Katsuren M, Ohigashi T, Sozu T, et al
Nephron. 2022;:1-8
Abstract
BACKGROUND Tranexamic acid is frequently reported to reduce bleeding-related complications in major surgery and trauma. We aimed to investigate whether tranexamic acid reduced hematoma size after percutaneous kidney biopsy. METHODS We conducted a double-blind, parallel three-group, randomized placebo-controlled trial at a teaching hospital in Japan between January 2016 and July 2018. Adult patients with clinical indication for ultrasound-guided percutaneous biopsy of a native kidney were included. Participants were randomly assigned into three groups: high-dose tranexamic acid (1,000 mg in total), low-dose tranexamic acid (500 mg in total), or placebo (counterpart saline). Intervention drugs were intravenously administered twice, as a bolus just before the biopsy and as a continuous infusion initiated just after the biopsy. Primary outcome was post-biopsy perirenal hematoma size as measured by ultrasound on the morning after the biopsy. RESULTS We assessed 90 adult patients for study eligibility, of whom 56 were randomly allocated into the three groups: 20 for high-dose tranexamic acid, 19 for low-dose tranexamic acid, and 17 for placebo. The median size of perirenal hematoma was 200 mm2 (interquartile range, 21-650) in the high-dose tranexamic acid group, 52 mm2 (0-139) in the low-dose tranexamic acid group, and 0 mm2 (0-339) in the placebo group (p = 0.048 for high-dose tranexamic acid vs. placebo). CONCLUSION In this trial, the median size of post-kidney biopsy hematoma was unexpectedly larger in the high-dose tranexamic acid group than in the placebo group. Although our results do not support the routine use of tranexamic acid in percutaneous kidney biopsy at present, further studies are needed to confirm the results.
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9.
A systematic review and meta-analysis of safety and efficacy of over the scope clips versus standard therapy for high-risk non-variceal upper gastrointestinal bleeding
Bapaye J, Chandan S, Naing LY, Shehadah A, Deliwala S, Bhalla V, Chathuranga D, Okolo PI 3rd
Gastrointestinal endoscopy. 2022
Abstract
BACKGROUND AND AIMS Upper gastro-intestinal bleeding is a common condition associated with significant morbidity and mortality. Endoscopic hemostasis remains the mainstay of therapy and is mainly aimed at effective hemostasis and prevention of rebleeding. Lesions with high-risk stigmata can have rebleeding rates of as high as 26.3%. Rebleeding is associated with increased mortality and reduced success rates of endoscopic retreatment. The over-the-scope-clip (OTSC) is a device with widespread endoscopic indications including hemostasis for non-variceal upper GIB (NVUGIB). The current study presents a systematic review and meta-analysis comparing OTSC versus standard therapy (STD) for NVUGIB. METHODS Multiple databases were searched through April 2022 for studies comparing OTSC and standard therapy for NVUGIBs. The primary outcomes were clinical success rates, rebleeding rates, procedure times and secondary outcomes were mortality rates and length of hospitalization. Meta-analysis was performed to determine pooled odds ratios (ORs) to compare outcomes between the OTSC and standard therapy groups. RESULTS Ten studies, including four randomized controlled trials, with 914 patients were included in the final analysis. 431 patients with NVUGIB's were treated with OTSC and 483 patients were treated with STD. Patients treated with OTSC had an overall lower risk of 7-day (RR 0.41 (95% CI 0.24-0.68, I(2) = 0%)) and 30-day rebleeding (RR 0.46 (95% CI 0.31-0.65, I(2) = 0%)). Clinical success rates were higher with OTSC compared with STD (RR 1.36 (95% CI 1.06 - 1.75. Mean procedure time was shorter in the OTSC group by 6.62 min (95% CI 2.58 - 10.67) vs STD therapy. I(2) = 84%. There was no statistically significant difference in terms of mortality between the OTSC and STD groups, RR 0.55 (95% CI 0.24-1.24, I(2) = 0%). Length of hospitalization was comparable between both groups with the pooled mean difference for OTSC vs STD being 0.87 d (-1.62 d - 3.36 d, I(2) = 71%). CONCLUSIONS While our study is limited to high-risk NVUGIB's, our analysis shows that hemostasis with OTSC is associated with a lower 7-day and 30-day rebleeding rate, higher clinical success rates and shorter procedure time with similar mortality rates and length of hospital stay as compared to standard therapy.
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10.
Tranexamic acid vs placebo and its impact on bleeding, transfusions and stone-free rates in percutaneous nephrolithotomy: a systematic review and meta-analysis
Hinojosa-Gonzalez DE, Flores-Villalba E, Eisner BH, Olvera-Posada D
Central European journal of urology. 2022;75(1):81-89
Abstract
INTRODUCTION Percutaneous nephrolithotomy (PCNL) is the standard of care for the treatment of large renal stones. Bleeding-related complications remain a major concern when performing this procedure. Tranexamic acid (TXA) has recently been studied in both urologic and non-urologic procedures to reduce bleeding, transfusions and complications. MATERIAL AND METHODS In June 2021 a systematic review was conducted following PRISMA guidelines on randomized prospective studies comparing the effects of TXA on bleeding complications during PCNL. Data was analyzed using Review Manager 5.3. RESULTS Eight studies were included with a total 1,201 patients, of which 598 received TXA and 603 received placebo. TXA was associated with less bleeding (decreased change in hemoglobin) -0.79 Hb g/dl [-1.09, -0.65] p <.00001 and decreased transfusion rates (OR 0.31 [0.18, 0.52] p <0.0001). This was also associated with lower complication rates, both minor, major and overall, OR 0.59[0.41, .85] p = 0.005, OR 0.31 [0.17, 0.56] p = 0.0001 and OR 0.40 [0.29, 0.56] p <0.00001 respectively. TXA was also associated with improved stone-free rates as compared with placebo (OR 1.79 [1.23, 2.62] p = 0.003). TXA resulted in shorter operative times (11.51 minutes [-16.25, -6.77] p =.001) and length of stay (-0.74 days [-1.13 -0.34] p = 0.0006). Two pulmonary embolisms were registered in a single study in the TXA group. CONCLUSIONS In this meta-analysis, the use of TXA during PCNL was associated with a statistically significant reduction in the following parameters when compared with placebo: change in hemoglobin, transfusion rates, complication rates, operative time, and length of stay. It was also associated with improvement in stone-free rates. These data should be considered by surgeons performing PCNL.