Primary studies included in this broad synthesis

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Primary study

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Journal The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology
Year 2016
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BACKGROUND/AIMS: In this study, the analgesic effectiveness of tramadol, a synthetic opioid, was compared with paracetamol and dexketoprofen in adult patients with acute pancreatitis in the emergency department. MATERIALS AND METHODS: Study drugs were similar in color and appearance, enabling the patients to be blind to the intervention. Study patients were intravenously administered 1 g paracetamol, 50 mg dexketoprofen trometamol, or 1 mg/kg tramadol with 100 mL normal saline with a 4-5 min infusion. Pain measurements of the patients were conducted at baseline and 30 min after the treatment intervention. Changes in pain scores were calculated by subtracting the median scores at baseline and 30 min as pairs. RESULTS: In this study, 90 patients were enrolled and included in the final analysis. The study subjects had a mean age of 53.5±13.3 years and 58.9% (n=53) of them were male. Gallstones and biliary etiology for pancreatitis was documented in 73.3% (n=66) of patients. Mean VAS scores at baseline and 30 min were similar in the three groups. Similarly, the change of scores from the baseline to the 30th minute did not differ among the groups. Comparison of pain improvements failed to reveal any differences among groups. CONCLUSION: Intravenous paracetamol, dexketoprofen, and tramadol are not superior to each other in the management of pain caused by nontraumatic acute pancreatitis.

Primary study

Unclassified

Journal Journal of gastroenterology and hepatology
Year 2016
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Introduction: Early management of severe acute pancreatitis (SAP) includes intravenous fluid resuscitation. Aim: To confirm feasibility of naso-jejunal (NJ) fluid resuscitation using oral hydration solution (ORS) and compare its efficacy with intravenous (IV) fluid resuscitation using Ringer Lactate (RL) in predicted SAP. Patients and Methods: All patients of predicted SAP (presence of SIRS or BISAP>2) without significant co morbidities were randomized to NJ group (ORS: 20ml/kg bolus and then 3mL/kg/h) or IV group (RL infusion at same rate). The groups were compared vis-à-vis persistent organ failure (POF), pancreatic necrosis, and mortality. Results: Seventy-seven patients were assessed and after exclusion, 49 patients were randomized to either NJ (24 patients) or IV group (25). The demographic and baseline clinical profile of both groups including BISAP score (2.25±0.73 and 2.32±0.56), hematocrit (40.2±6.8 and 38.3±6.6), blood urea nitrogen (16.88±6.69 and 21.44±17.56mg/dL), and intra-abdominal pressure (14.55±4.8 and 14.76±5.5cm of water) were similar. NJ resuscitation had to be stopped in two patients because of abdominal discomfort and distension. The change in intra abdominal pressure after 48h of hydration was comparable in both groups. The occurrence of POF (66.67% and 68%), pancreatic necrosis (69.5% and 76%), intervention (5 each), surgery (1 each), and mortality (16.5% and 8%) were comparable (P>0.05). Conclusion: In select group of patients with SAP, NJ fluid resuscitation with ORS is feasible and is equally efficacious as IV fluid resuscitation with RL. © 2016 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

Primary study

Unclassified

Journal Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition
Year 2016
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BACKGROUND: Evidence from animal studies suggests that gastrointestinal motility is impaired in acute pancreatitis. Enteral nutrition, and more specifically nasogastric tube feeding, has emerged as a key treatment modality in patients with acute pancreatitis, but its effect on motility has not been investigated in this setting. The aim was to validate the Gastroparesis Cardinal Symptom Index (GCSI) in patients with acute pancreatitis and determine the effect of nasogastric tube feeding on GCSI. METHODS: The study design was a randomized controlled trial. Patients were allocated to nasogastric tube feeding or nil per os within 24 hours of hospital admission. GCSI data from before randomization to 72 hours after randomization were analyzed. The test-retest reliability analysis was used to calculate Cronbach's α. RESULTS: Seventeen patients were randomized to nasogastric tube feeding and 18 to nil per os. Overall, the total GCSI score significantly decreased over the study (F = 8.537; P = .001) but was not significantly different between the 2 study groups during hospitalization (F = 1.159; P = .322). However, patients on nasogastric tube feeding did show improved appetite compared with nil per os (F = 3.526; P = .036). The GCSI was found to be a reliable tool in the setting of acute pancreatitis (Cronbach's α = 0.852). CONCLUSIONS: Nasogastric tube feeding does not appear to affect dysmotility symptoms in acute pancreatitis as measured by the GCSI, although appetite improved. Use of the simple, noninvasive, and inexpensive GCSI tool to evaluate motility is recommended in future clinical trials in pancreatology.

Primary study

Unclassified

Journal World journal of gastroenterology
Year 2015
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AIM: To study the safety of epidural anesthesia (EA), its effect on pancreatic perfusion and the outcome of patients with acute pancreatitis (AP). METHODS: From 2005 to August 2010, patients with predicted severe AP [Ranson score ≥ 2, C-reactive protein > 100 or necrosis on computed tomography (CT)] were prospectively randomized to either a group receiving EA or a control group treated by patient controlled intravenous analgesia. Pain management was evaluated in the two groups every eight hours using the visual analog pain scale (VAS). Parameters for clinical severity such as length of hospital stay, use of antibiotics, admission to the intensive care unit, radiological/clinical complications and the need for surgical necrosectomy including biochemical data were recorded. A CT scan using a perfusion protocol was performed on admission and at 72 h to evaluate pancreatic blood flow. A significant variation in blood flow was defined as a 20% difference in pancreatic perfusion between admission and 72 h and was measured in the head, body and tail of the pancreas. RESULTS: We enrolled 35 patients. Thirteen were randomized to the EA group and 22 to the control group. There were no differences in demographic characteristics between the two groups. The Balthazar radiological severity score on admission was higher in the EA group than in the control group (mean score 4.15 ± 2.54 vs 3.38 ± 1.75, respectively, P = 0.347) and the median Ranson scores were 3.4 and 2.7 respectively (P = NS). The median duration of EA was 5.7 d, and no complications of the epidural procedure were reported. An improvement in perfusion of the pancreas was observed in 13/30 (43%) of measurements in the EA group vs 2/27 (7%) in the control group (P = 0.0025). Necrosectomy was performed in 1/13 patients in the EA group vs 4/22 patients in the control group (P = 0.63). The VAS improved during the first ten days in the EA group compared to the control group (0.2 vs 2.33, P = 0.034 at 10 d). Length of stay and mortality were not statistically different between the 2 groups (26 d vs 30 d, P = 0.65, and 0% for both respectively). CONCLUSION: Our study demonstrates that EA increases arterial perfusion of the pancreas and improves the clinical outcome of patients with AP.

Primary study

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BACKGROUND: Early enteral feeding through a nasoenteric feeding tube is often used in patients with severe acute pancreatitis to prevent gut-derived infections, but evidence to support this strategy is limited. We conducted a multicenter, randomized trial comparing early nasoenteric tube feeding with an oral diet at 72 hours after presentation to the emergency department in patients with acute pancreatitis. METHODS: We enrolled patients with acute pancreatitis who were at high risk for complications on the basis of an Acute Physiology and Chronic Health Evaluation II score of 8 or higher (on a scale of 0 to 71, with higher scores indicating more severe disease), an Imrie or modified Glasgow score of 3 or higher (on a scale of 0 to 8, with higher scores indicating more severe disease), or a serum C-reactive protein level of more than 150 mg per liter. Patients were randomly assigned to nasoenteric tube feeding within 24 hours after randomization (early group) or to an oral diet initiated 72 hours after presentation (on-demand group), with tube feeding provided if the oral diet was not tolerated. The primary end point was a composite of major infection (infected pancreatic necrosis, bacteremia, or pneumonia) or death during 6 months of follow-up. RESULTS: A total of 208 patients were enrolled at 19 Dutch hospitals. The primary end point occurred in 30 of 101 patients (30%) in the early group and in 28 of 104 (27%) in the on-demand group (risk ratio, 1.07; 95% confidence interval, 0.79 to 1.44; P=0.76). There were no significant differences between the early group and the on-demand group in the rate of major infection (25% and 26%, respectively; P=0.87) or death (11% and 7%, respectively; P=0.33). In the on-demand group, 72 patients (69%) tolerated an oral diet and did not require tube feeding. CONCLUSIONS: This trial did not show the superiority of early nasoenteric tube feeding, as compared with an oral diet after 72 hours, in reducing the rate of infection or death in patients with acute pancreatitis at high risk for complications. (Funded by the Netherlands Organization for Health Research and Development and others; PYTHON Current Controlled Trials number, ISRCTN18170985.).

Primary study

Unclassified

Authors Wan B , Fu H , Yin J , Xu F
Journal Scandinavian journal of gastroenterology
Year 2014
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OBJECTIVE: To investigate the effect of rhubarb combined with early enteral nutrition (EEN) on the gastrointestinal function, disease severity and systemic inflammation in patients with severe acute pancreatitis (SAP). METHODS: A total of 126 patients with SAP were randomly assigned into three groups: parenteral nutrition group, treated with standard solution first and EN 14 days later; EEN group, treated with EN suspension; or EEN combined with rhubarb group, treated with rhubarb and then EN 2 h later. The gastrointestinal function, APACHE II scores, the levels of plasma IL-6, IL-11, C-reactive proteins (CRP) and the liver and kidney functional measures were longitudinally analyzed. RESULTS: Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays. The combination of EEN and rhubarb significantly reduced the values of APACHE II scores. Combination therapies significantly reduced abnormally higher white blood cell (WBC) counts and levels of plasma CRP and IL-6, but increased the levels of plasma IL-11. Finally, combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase, aspartate aminotransferase, and creatinine (Cr). CONCLUSION: Combination of EEN and rhubarb significantly improved the gastrointestinal function, inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients.

Primary study

Unclassified

Journal Clinical nutrition (Edinburgh, Scotland)
Year 2013
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Summary: Background & aims: Nasojejunal tube feeding is a standard of care in patients with predicted severe acute pancreatitis (AP) and several recent trials suggested that nasogastric tube feeding (NGT) is as safe and efficient as nasojejunal tube feeding in these patients. The aim was to investigate whether NGT presents any benefit to patients with mild to moderate AP. METHODS: The study design was a randomized controlled trial. The patients in the intervention group received NGT within 24 h of hospital admission. The patients in the control group were on nil per os (NPO). The severity of acute pancreatitis was determined according to the new international multidisciplinary classification. RESULTS: There were 17 patients randomly allocated to the NGT group and 18 to the NPO group. The visual analogue pain score decreased to a significantly greater extent in the NGT group (from median 9 (range 7–9) at baseline to 1 (0–3) at 72 h after randomization) compared with the NPO group (from 7 (5–9) to 3 (1–4) (p = 0.036). The number of patients not requiring opiates at 48 h after randomization was significantly different (p = 0.024) between NGT (9/17) and NPO (3/18). Oral food intolerance was observed in 1/17 patient in the NGT group and 9/18 patients in the NPO group (p = 0.004). The overall hospital stay in the NGT group was 9 (5–12) days as compared with 8.5 (6–13) days in the NPO group (p = 0.91). CONCLUSIONS: NGT commenced within 24 h of hospital admission is well tolerated in patients with mild to moderate acute pancreatitis. Further, when compared with NPO, it significantly reduces the intensity and duration of abdominal pain, need for opiates, and risk of oral food intolerance, but not overall hospital stay (ClinicalTrials.gov number, NCT01128478).

Primary study

Unclassified

Authors Sun JK , Mu XW , Li WQ , Tong ZH , Li J , Zheng SY
Journal World journal of gastroenterology
Year 2013
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AIM: To investigate the effects of early enteral nutrition (EEN) on the immune function and clinical outcome of patients with severe acute pancreatitis (SAP). METHODS: Patients were randomly allocated to receive EEN or delayed enteral nutrition (DEN). Enteral nutrition was started within 48 h after admission in EEN group, whereas from the 8(th) day in DEN group. All the immunologic parameters and C-reactive protein (CRP) levels were collected on days 1, 3, 7 and 14 after admission. The clinical outcome variables were also recorded. RESULTS: Sixty SAP patients were enrolled to this study. The CD4+ T-lymphocyte percentage, CD4+/CD8+ ratio, and the CRP levels in EEN group became significantly lower than in DEN group from the 7(th) day after admission. In contrast, the immunoglobulin G (IgG) levels and human leukocyte antigen-DR expression in EEN group became significantly higher than in DEN group from the 7(th) day after admission. No difference of CD8+ T-lymphocyte percentage, IgM and IgA levels was found between the two groups. The incidences of multiple organ dysfunction syndrome, systemic inflammatory response syndrome, and pancreatic infection as well as the duration of intensive care unit stay were significantly lower in EEN group than in DEN group. However, there was no difference of hospital mortality between the two groups. CONCLUSION: EEN moderates the excessive immune response during the early stage of SAP without leading to subsequent immunosuppression. EEN can improve the clinical outcome, but not decrease the hospital mortality of SAP patients.

Primary study

Unclassified

Journal Pancreas
Year 2012
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Objective: This study aimed to determine the noninferiority of early enteral feeding through nasogastric (NG) compared to nasojejunal (NJ) route on infectious complications in patients with severe acute pancreatitis (SAP). Methods: Patients with SAP were fed via NG (candidate) or NJ (comparative) route. The primary outcome was the occurrence of any infectious complication in blood, pancreatic tissue, bile, or tracheal aspirate. Secondary end points were pain in refeeding, duration of hospital stay, intestinal permeability assessed by lactulose/mannitol excretion, and endotoxemia assessed by endotoxin core antibody types immunoglobulin G and M. Results: Seventy-eight patients were randomized to feeding by either the NG or the NJ route. During the hospital stay, the presence of any infectious complication in the NG and NJ groups was 23.1% and 35.9% (significantly different), respectively. The effect size of the difference of infectious complications was -12.8 (95% confidence interval, -29.6 to 4.0). The upper limit of the 95% confidence interval was 4.0 and was within the 5% limit set for noninferiority. The value of 8.0 for the number needed to treat implies that 8 patients should be treated with NG compared with the NJ group to prevent 1 patient from any of the infectious complications. Conclusions: Early enteral feeding through NG was not inferior to NJ in patients with SAP. Infectious complications were within the noninferiority limit. Pain in refeeding, intestinal permeability, and endotoxemia were comparable in both groups. Copyright © 2012 by Lippincott Williams & Wilkins.

Primary study

Unclassified

Journal Pancreas
Year 2011
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OBJECTIVES: Intravenous local anesthetics may ameliorate pain and clinical course in patients with major abdominal surgery. AIM: To investigate their effects in acute pancreatitis. METHODS: Forty-six consecutive patients with acute pancreatitis randomly received intravenous procaine (2 g/24 h) or placebo for 72 hours in a double-blind fashion. Pain severity (visual analog scale, 0-100), on-demand pain medication (metamizole and/or buprenorphine), and the clinical course were monitored every 24 hours. RESULTS: Data of 44 patients were subjected to intention-to-treat analysis. Although there were no differences between groups before treatment, procaine treatment was associated with a stronger decrease in pain compared with placebo (median visual analog scale decrement, -62 vs -39, P = 0.025). Moreover, there was a greater proportion of patients with adequate (≥ 67%) pain reduction (75% vs 43%, P = 0.018), less use of additional analgesics (P = 0.042), and overall analgesic superiority (P = 0.015). Compared with placebo, the proportion of patients hospitalized after 2 weeks was reduced by 80% after procaine treatment (P = 0.012). CONCLUSIONS: These findings support the hypothesis that systemic administration of local anesthetics might improve pain and accelerate clinical recovery in acute pancreatitis.