Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial
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.
The Role of the Endoscopic Doppler Probe in Non-Variceal Upper Gastrointestinal Bleeding: a systematic review and meta-analysis
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2022
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.
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.
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
Indian journal of urology : IJU : journal of the Urological Society of India. 2022;38(1):53-61
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.
Regional vessels wrapping following pancreaticoduodenectomy reduces the risk of post-operative extra-luminal bleeding. A systematic review
Annals of medicine and surgery (2012). 2022;82:104618
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.
Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases
Journal of clinical pharmacy and therapeutics. 2022
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.
Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial
The British journal of surgery. 2022
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).
Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)
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.
High-risk patients with acute non-variceal upper gastrointestinal bleeding enrolled in the STING-2 trial (n= 100).
First-line over-the-scope-clips therapy (OTSC group, n= 48).
Standard endoscopic treatment (ST group, n= 52).
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.
Intravenous Tranexamic Acid in Percutaneous Kidney Biopsy: A Randomized Controlled Trial
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.
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.