Randomized Prospective Trial of Early Versus Delayed Feeding After Percutaneous Endoscopic Gastrostomy Placement

Objective : By convention, most clinicians delay feeding through the gastrostomy tube until 24 h after placement. However, evidence is lacking to support the rationale for such a delay in PEG use. This randomized, prospective study was designed to assess the safety of early feeding after PEG placement. Methods : One hundred-twelve patients referred for PEG were randomized to begin tube feedings at 4 h (group A) or at 24 h (group B) after placement. All patients received prophylactic antibiotics. Full-strength Isocal was administered with the following schedule: day 1,100 ml every 4 h for six feedings; day 2, 200 ml every 4 h for six feedings. Immediately before each scheduled feeding, gastric residual volume was recorded and the next feeding was withheld if the residual volume was > 50 percent (gastric retention). Patients were evaluated on day 1, day 2, day 7, and day 30 for major and minor complications. Results : The two groups were similar with regard to age, gender, baseline nutritional status, and indications for PEG placement. On the first day of feeding, 14 of 57 patients (25%) in group A, but only five of 55 patients (9%) in group B, had evidence of gastric retention,   p × 0.029  . The proportion of patients with high gastric residual volumes was not significantly different on day two. In group B, one death occurred because of aspiration of gastric contents on day 2. All other complications were minor and did not differ significantly between the two groups. Conclusions : Early initiation of PEG feedings is safe, well tolerated, and reduces cost by decreasing hospital stay.     

卡维地洛前瞻性累计生存试验(COPERNICUS)

标　　题　卡维地洛治疗临床重度心衰患者的生存率研究作　　者　ＰａｃｋｅｒＭ ,2 0 0 0年 8月第 2 2届欧洲心脏病大会　　研究疾病　成人有症状的重度心衰目　　的　评价卡维地洛对严重的慢性心衰患者的总死亡率的影响。设　　计　随机、双盲、多中心、安慰剂对照。病人资料　 2 2 89例男、女性 ,年龄 >18岁 ,缺血和非缺血性严重心衰(ＮＹＨＡⅣ级 ,ＬＶＥＦ <0 2 5 )。随机分成卡维地洛组和安慰剂组。随　　访　 1 2 5～ 3 75年。治疗方案　卡维地洛起始剂量为3 12 5ｍｇ,Ｂｉｄ ,每两周剂量加倍至12 5ｍｇ ,Ｂｉｄ ,或若能耐受至靶剂…     

The Need for Second-Look Endoscopy to Prevent Delayed Bleeding after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Trial

Background/Aims

Many authors recommend performing a second-look endoscopy (SLE) to reduce the frequency of delayed bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms, but these recommendations have been made despite a lack of reliable evidence supporting the effectiveness of SLE.

Methods

From January 2012 to May 2013, we investigated 441 gastric neoplasms treated by ESD to assess the risk factors for delayed bleeding. Delayed bleeding occurred in four of these lesions within 1 postoperation day. Therefore, we enrolled the patients with the remaining 437 lesions to determine the utility of SLE performed on the morning of postoperative day 2. All lesions were randomly assigned to SLE (220 lesions) groups or non-SLE (217 lesions) groups.

Results

Delayed bleeding occurred in 18 lesions (4.1%). A large tumor size (>20 mm) was the only independent risk factor for delayed bleeding (p=0.007). The chance of delayed bleeding was not significantly different between the patients receiving a SLE (eight cases) and those patients not receiving a SLE (six cases, p=0.787). Furthermore, SLE for lesions with a large tumor size did not significantly decrease delayed bleeding (p=0.670).

Conclusions

SLE had little or no influence on the prevention of delayed bleeding, irrespective of the risk factors.     

Evaluating the Angina Plan in Patients Admitted to Hospital with Angina: A Randomized Controlled Trial

The aim of this trial was to evaluate the Angina Plan (AP), a cognitive‐behavioral nurse‐facilitated self‐help intervention against standard care (SC). A randomized controlled trial of 218 patients hospitalized with angina assessed participants predischarge and 6 months later. Data were collected during a structured interview using validated questionnaires, self‐report, and physiological measurement to assess between group changes in mood, knowledge and misconceptions, cardiovascular risk, symptoms, quality of life, and health service utilization. The intention‐to‐treat (ITT) analysis found no reliable effects on anxiety and depression at 6 months. AP participants reported increased knowledge, less misconceptions, reduced body mass index (BMI), an increase in self‐reported exercise, less functional limitation, and improvements in general health perceptions and social and leisure activities compared to those receiving SC. Sensitivity analysis excluding participants with high baseline depression revealed a statistical significant reduction in depression levels in AP compared to the SC participants. Analysis excluding participants receiving cardiac surgery or angioplasty removed the ITT effects on physical limitation, self‐reported exercise and general health perceptions and the improvements seen in social and leisure activities, while adaptive effects on knowledge, misconceptions and BMI remained and between‐group changes in depression approached significance. Initiating the AP in a secondary care setting for patients with new and existing angina produces similar benefits to those reported in newly diagnosed primary care patients. Further evaluation is required to examine the extent of observed effects in the longer term.     

Bispectral Index Monitoring for Nurse-Administered Propofol Sedation During Upper Endoscopic Ultrasound: A Prospective,Randomized Controlled Trial

Bispectral index monitoring (BIS) is a quantitative assessment of brain cortical activity. The aim of this study was to determine if BIS-guided nurse-administered propofol sedation would decrease by >/=20% both recovery time and propofol dose compared to standard propofol sedation for endoscopic ultrasound (EUS). Prospectively, eligible outpatients were randomized to BIS-guided or standard propofol sedation during EUS. Propofol was given by nurses in intermittent boluses with sedation targeted at a BIS score of <65-75. For the control group, the nurse was blinded to BIS scores and sedation was titrated to a modified observer's assessment of alertness/sedation scale (MOAA/S) score 相似文献   

Acute Ulcer Bleeding (A Prospective Randomized Trial to Compare Doppler and Forrest Classifications in Endoscopic Diagnosis and Therapy)

The aim of our prospective randomized studyinvolving 100 patients was to investigate whetherDoppler ultrasound can be used to select patients atrisk for ulcer rebleeding. Ulcers in the Forrest group classified as having a visible vessel or a clotwere treated prophylactically by injection withepinephrine solution. In the Doppler group, in contrast,only ulcers with a positive Doppler signal were treated endoscopically. In the Doppler group, rebleedsoccurred significantly less frequently (2%, P < 0.03)than in the Forrest group (14%). Emergency surgery wasonly necessary in the Forrest group (0% vs 5%; P =0.02). Bleeding-related mortality was 0% and 4% (P =0.15) and the overall mortality 0% and 10% (P = 0.02),in the Doppler and Forrest groups, respectively. Theseresults appear to show that Doppler-based injection treatment is superior to endoscopictreatment based exclusively on the Forrestclassification. In our study, Doppler-based localendoscopic treatment reduced the danger of a rebleed andthus the number of emergency operations and the overallmortality.     

Prospective Randomized Trial of External Versus Internal Transcatheter Cardioversion in Patients with Chronic Atrial Fibrillation

To evaluate the safety and long-term efficacy of internal transcatheter cardioversion, forty patients with chronic, lone atrial fibrillation were studied. The patients were randomised to internal transcatheter cardioversion or to conventional external cardioversion. In cases where the procedure was unsuccessful, cross-over to the alternate method was performed. Oral anticoagulation therapy was started three weeks prior to the procedure and was maintained for another three weeks following successful cardioversion.Sinus rhythm was restored in 16/18 patients (88%) in the internal cardioversion group, versus 9/22 patients (40%) in the external cardioversion group (p < 0.01). In addition, 8/13 (61%) patients who were crossed-over to internal cardioversion were successfully cardioverted to sinus rhythm. In contrast, both patients who were crossed-over to external cardioversion remained in atrial fibrillation.During a mean follow-up period of 23 months, 13 (39.3%) patients maintained sinus rhythm. Using the intention to treat principle, the recurrence rate was not statistically different between the two methods.It is concluded that internal cardioversion is more effective in acutely restoring sinus rhythm compared to external cardioversion. However, both methods have similar long-term recurrence rates.     

A Prospective Multicenter Randomized Feasibility Trial of Double-guidewire Techniques for Difficult Biliary Cannulation Comparing a New Double-guidewire-supported Sphincterotome (MagicTome) to a Conventional Device

Objective To evaluate the effectiveness and safety of the double-guidewire technique (DGT) using a new double-guidewire-supported sphincterotome (MagicTome) for patients who required endoscopic retrograde cholangiopancreatography (ERCP) for biliary cannulation. Methods This prospective multicenter randomized feasibility trial involved patients with difficult biliary cannulation at any of the three study sites from June 2017 to October 2018. Patients were assigned to the DGT with MagicTome (MDGT) initially performed group and the conventional DGT (CDGT) initially performed group. The success rates of biliary cannulation by MDGT and CDGT and the ERCP-related complications were evaluated. Results Twenty-eight patients were included in this study. No significant difference was observed in the success rates of first attempts and crossover attempts between the groups (p=0.69 and p=1.00). Furthermore, no significant difference was observed in the success rate of biliary cannulation between MDGT and CDGT (62.5% and 75.0%, respectively; p=0.48). CDGT was successful in two of four patients with malignant biliary obstruction. MDGT was successful in all four patients with malignant biliary obstruction, including the two for whom CDGT was unsuccessful. Post-ERCP pancreatitis occurred in only one MDGT case. Conclusion MDGT is safe for biliary cannulation and can be used in cases where biliary cannulation by CDGT is difficult.     

Prospective Trial Evaluating Early Initiation of Feeding in Patients with Newly Placed One-Step Button Gastrostomy Devices

The purpose of this study was to prospectively assess the feasibility and safety of early feeding in patients with newly placed one-step button (OSB) gastrostomy devices. Twenty-five patients who underwent percutaneous endoscopic button gastrostomy placement were prospectively enrolled. The patients underwent radiographic assessment (Gastrografin gastrograms) 3 hr after gastrostomy placement. Contrast extravasation was not documented in any patient. Aside from one patient who aspirated the contrast solution after the radiologic study, all others (96%) were successfully fed on the day the gastrostomy buttons were placed. In this prospective study of patients with newly placed OSB gastrostomy devices, early initiation of feeding was feasible and safe. In a fashion similar to their tube-style counterparts, button gastrostomy devices provide adequate apposition between the stomach and abdominal wall immediately after their initial placement.