Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial.

BACKGROUND: Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients. METHODS: This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton's criteria. RESULTS: One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87% (4/82) in the study group and 20.23% (17/84) in the placebo group; this difference was significant (P = 0.01). According to Cotton's criteria, 17 patients (80.9%) developed mild pancreatitis and 4 (19.1%) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P = 0.60). Based on these results, an absolute risk reduction of 0.15 (15%), a relative risk reduction of 0.75 (75%) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality. CONCLUSIONS: Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication. TRIAL REGISTRATION: National Clinical Trials NCT02110810. Date April 7, 2014.

Long-term outcome after percutaneous endoscopic gastrostomy in geriatric Mexican patients.

AIM: To evaluate long-term survival and prognostic factors in elderly Mexican patients who have undergone percutaneous endoscopic gastrostomy (PEG). METHODS: The present study was a retrospective cohort analysis of 110 patients aged older than 70 years without head and neck malignancy who underwent PEG between January 2005 and December 2012. Odds ratios (OR) and 95% confidence intervals (CI) were calculated for demographic and clinical variables, and survival was determined by the Kaplan-Meier method. RESULTS: Medium age and follow up were 82.45 ± 6.6 years and 688.3 ± 394.6 days, respectively. The patients who died in the early postoperative period (n = 6) were older than those who survived. The Karnofsky performance status and lymphocyte count were non-significantly lower in non-survivors. The body mass index and serum albumin level were lower in non-survivors (P = 0.03 and 0.01, respectively) and Charlson's Comorbidity Index (CCI) was higher. A total of 32 (29%) patients died later in the postoperative period with a mean follow up of 436.2 ± 267.4 days. Risk factors for mortality included Karnofsky Performance Status (odds ratio [OR] 9.76, 95% CI: 3.26-29.3), CCI (OR 7.04, 95% CI: 2.31-21.41) and postoperative hypoalbuminemia (OR 3.45, 95% CI: 1.71-6.67). Postgastrostomy pneumonia occurred in 36.8% of the patients who died during follow-up (OR 0.28, 95% CI: 0.6-1.26). CONCLUSIONS: Karnofsky performance status, Charlson's comorbidity index and postoperative hypoalbuminemia, were independent risk factors for mortality. Modifiable factors are related to nutritional support. Early PEG may help prevent malnutrition and infection.

Serum albumin level as a risk factor for mortality in burn patients.

OBJECTIVE: Hypoalbuminemia is a common clinical deficiency in burn patients and is associated with complications related to increased extravascular fluid, including edema, abnormal healing, and susceptibility to sepsis. Some prognostic scales do not include biochemical parameters, whereas others consider them together with comorbidities. The purpose of this study was to determine whether serum albumin can predict mortality in burn patients. METHODS: We studied burn patients ≥16 years of age who had complete clinical documentation, including the Abbreviated Burn Severity Index, serum albumin, globulin, and lipids. Sensitivity and specificity analyses were performed to determine the cut-off level of albumin that predicts mortality. RESULTS: In our analysis of 486 patients, we found that mortality was higher for burns caused by flame (p=0.000), full-thickness burns (p=0.004), inhalation injuries (p=0.000), burns affecting >30% of the body surface area (p=0.001), and burns associated with infection (p=0.008). Protein and lipid levels were lower in the patients who died (p<0.05). Albumin levels showed the highest sensitivity and specificity (84% and 83%, respectively), and the area under the receiver-operating characteristic curve (0.869) had a cut-off of 1.95 g/dL for mortality. CONCLUSION: Patients with albumin levels <2 g/dL had a mortality risk of >80%, with 84% sensitivity and 83% specificity. At admission, the albumin level could be used as a sensitive and specific marker of burn severity and an indicator of mortality.

Serum albumin level as a risk factor for mortality in burn patients

OBJECTIVE: Hypoalbuminemia is a common clinical deficiency in burn patients and is associated with complications related to increased extravascular fluid, including edema, abnormal healing, and susceptibility to sepsis. Some prognostic scales do not include biochemical parameters, whereas others consider them together with comorbidities. The purpose of this study was to determine whether serum albumin can predict mortality in burn patients. METHODS: We studied burn patients ≥16 years of age who had complete clinical documentation, including the Abbreviated Burn Severity Index, serum albumin, globulin, and lipids. Sensitivity and specificity analyses were performed to determine the cut-off level of albumin that predicts mortality. RESULTS: In our analysis of 486 patients, we found that mortality was higher for burns caused by flame (p = 0.000), full-thickness burns (p = 0.004), inhalation injuries (p = 0.000), burns affecting >30% of the body surface area (p = 0.001), and burns associated with infection (p = 0.008). Protein and lipid levels were lower in the patients who died (p<0.05). Albumin levels showed the highest sensitivity and specificity (84% and 83%, respectively), and the area under the receiver-operating characteristic curve (0.869) had a cut-off of 1.95 g/dL for mortality. CONCLUSION: Patients with albumin levels <2 g/dL had a mortality risk of >80%, with 84% sensitivity and 83% specificity. At admission, the albumin level could be used as a sensitive and specific marker of burn severity and an indicator of mortality. .