John Blomberg

Complications after percutaneous endoscopic gastrostomy in a prospective study

Abstract Background. Insertion of a percutaneous endoscopic gastrostomy (PEG) is an increasingly common procedure in patients with nutritional needs and dysphagia. Better knowledge of rates and patterns of complications after PEG might influence decision-making. Material and methods. The objective was to prospectively evaluate the rate of six pre-defined complications (leakage, diarrhea, constipation, abdominal pain, fever and peristomal infection) and mortality occurring within 2 months after PEG in an unselected sample of patients. All patients (n = 484) who had a PEG inserted at the hospital during the study period were included. Kaplan–Meier curves were used to estimate mortality over the first 60 days following PEG and Fishers exact test was used to test equality of proportions. Results. Of the 484 patients included, 85 (18%) died within 2 months after PEG insertion. The risk of early mortality was higher in the group with neurological disease than in the group with a tumor as indication (p < 0.001). After excluding mortality, the overall complication rates at 2 weeks and 2 months were 39% and 27%, respectively. The most common complications within 2 weeks were abdominal pain (13%), peristomal infection (11%), diarrhea (11%) and leakage (10%). At 2 months the most frequent complications were diarrhea (10%), leakage (8%) and peristomal infection (6%). Conclusions. In the short-term perspective, there is a substantial risk of complications, including mortality, after PEG insertion. This should be considered during clinical decision-making and when informing the patients and caregivers.

Albumin and C-reactive protein levels predict short-term mortality after percutaneous endoscopic gastrostomy in a prospective cohort study

BACKGROUND Percutaneous endoscopic gastrostomy (PEG) is a procedure with many complications that sometimes can be devastating. To give better advice to patients referred for PEG regarding risk of complications, important risk factors should be known. OBJECTIVE To evaluate whether age, body mass index, albumin levels, C-reactive protein (CRP) levels, indication for PEG, and comorbidity influence the risk of mortality or peristomal infection after PEG insertion. DESIGN Prospective cohort study from 2005 to 2009. Follow-up 14 days after PEG. SETTING University hospital. PATIENTS This study involved 484 patients referred for PEG. INTERVENTION PEG. MAIN OUTCOME MEASUREMENTS Mortality within 30 days and peristomal infection within 14 days after PEG insertion. All risk estimates were calculated with 95% CIs and adjusted for confounding. RESULTS Among 484 patients, 58 (12%) died within 30 days after PEG insertion. Albumin <30 g/L (hazard ratio [HR], 3.46; 95% CI, 1.75-6.88), CRP ≥10 (HR, 3.47; 95% CI, 1.68-7.18), age ≥65 years (HR, 2.26; 95% CI, 1.20-4.25) and possibly body mass index <18.5 (HR, 2.04; 95% CI, 0.97-4.31) were associated with increased mortality. Patients with a combination of low albumin and high CRP levels had a mortality rate of 20.5% compared with 2.6% among patients with normal values, rendering an over 7-fold increased adjusted risk of mortality (HR, 7.45; 95% CI, 2.62-21.19). LIMITATIONS Missing data in some study variables. Although the sample size was large, weaker associations could not be established. CONCLUSION The combination of low albumin and high CRP levels indicates a substantially increased short-term mortality risk after PEG, which should be considered in decision making.

Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial

Objective To evaluate a new and simpler strategy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG). Design Single centre, two arm, randomised, controlled, double blind clinical trial. Setting Endoscopy unit in Karolinska University Hospital, Stockholm, Sweden, between 3 June 2005 and 31 October 2009. Participants 234 patients with an indication for PEG who gave informed consent to participate. Intervention A single 20 ml dose of the oral solution of sulfamethoxazole and trimethoprim (also known as co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd, Basel, Switzerland) deposited in the PEG catheter immediately after insertion. The control group received standard prophylaxis consisting of a single intravenous dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline, London) administered before insertion of the PEG tube. Main outcome measure Primary outcome was the occurrence of clinically evident wound infection within 14 days after insertion of the PEG catheter. Secondary outcomes were positive bacterial culture and blood tests (highly sensitive C reactive protein and white blood cell count). All randomised patients were included in an intention to treat analysis. Results Of the 234 patients included in this study, 116 were randomly assigned to co-trimoxazole and 118 to cefuroxime. At follow-up 7-14 days after insertion of the PEG catheter, wound infection was found in 10 (8.6%) patients in the co-trimoxazole group and 14 (11.9%) in the cefuroxime group, which corresponds to a percentage point difference of −3.3% (95% confidence interval −10.9% to 4.5%). The per protocol analysis, which comprised 100 patients in each group, gave similar results—10% and 13% infection in the co-trimoxazole and cefuroxime groups, respectively (percentage point difference −3.0%, 95% CI −11.8% to 5.8%). Both these analyses indicate non-inferiority of co-trimoxazole compared with cefuroxime because the upper bounds of the confidence intervals are lower than the pre-determined non-inferiority margin of 15%. Analyses of the secondary outcomes supported this finding. Conclusion 20 ml of co-trimoxazole solution deposited in a newly inserted PEG catheter is at least as effective as cefuroxime prophylaxis given intravenously before PEG at preventing wound infections in patients undergoing PEG. Trial registration Current Controlled Trials ISRCTN18677736.

Antireflux stent versus conventional stent in the palliation of distal esophageal cancer. A randomized, multicenter clinical trial

Abstract Objective. Patients with incurable distal esophageal or cardia cancer often need palliative stenting to relieve their dysphagia but stents passing through the cardia can cause reflux and aspiration, leading to a reduced health-related quality of life (HRQL). This study addressed the hypothesis that antireflux stenting improves HRQL compared to conventional stenting. Material and methods. In a single-blind, multicenter, randomized trial in patients with inoperable esophageal or cardia cancer requiring palliative stenting passing through the cardia, 65 patients were stented. Patients received either an antireflux stent (Esophageal Z-Stent with Dua antireflux valve; n = 28) or a conventional stent (Esophageal Z-stent, Ultraflex or Wallstent; n = 37). Validated questionnaires (European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OES18) were used to collect information on HRQL at baseline and 1 and 3 months after stenting. Main outcome measurements were differences in HRQL scores between baseline and 1 and 3 months after stenting. Results. Scores for most aspects of HRQL were similar in the two groups, and no statistically significant differences were found. Some general symptoms however showed clinically relevant improvement in the antireflux stent group, while esophageal-specific symptoms such as dysphagia seemed clinically better, and symptoms of reflux were clinically reduced in the conventional stent group but not in the antireflux stent group. Conclusion. This study, although limited in size, provided no obvious support for using the antireflux stent in preference to the conventional stent in the palliation of distal esophageal or cardia cancer from an HRQL perspective.

Impact of delay between imaging and treatment in patients with potentially curable pancreatic cancer

Locoregional pancreatic ductal adenocarcinoma (PDAC) may progress rapidly and/or disseminate despite having an early stage at diagnostic imaging. A prolonged interval from imaging to resection might represent a risk factor for encountering tumour progression at laparotomy. The aim of this study was to determine the therapeutic window for timely surgical intervention.

Impact of body mass index for patients undergoing pancreaticoduodenectomy

AIM To evaluate the impact of body mass index (BMI) on short and long term results after pancreaticoduodenectomies (PD). METHODS A consecutive series of PDs performed at the Karolinska University Hospital from 2004 till 2010 were retrieved from our prospective database. The patients were divided by BMI into overweight/obese (O; BMI ≥ 25 kg/m(2)) and controls (C; BMI < 25 kg/m(2)). Demographics, peri-operative data, morbidity, mortality, pancreatic fistula (PF) rate, length of stay (LOS), hospital costs, histology, and survival were analyzed. An additional sub analysis of survival was performed in patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and divided in underweight, normal-weight, overweight and obese. RESULTS A total of 367 PDs were included (O = 141/C = 226). No differences were found between O and C regarding demographics, peri-operative data, costs, morbidity or mortality. O was associated with higher intra-operative blood loss (1392 ± 115 mL vs 1121 ± 83 mL; P = 0.01), rate of PF (20% vs 9.5%; P = 0.006) and marginally longer LOS (18 ± 0.9 d vs 15 ± 1.1 d; P = 0.05). An increasing risk for PF was observed with increasing BMI. The 1, 3 and 5 years survival rate was similar in O and C in PDAC (68.7%, 26.4% and 8.8% vs 66.1%, 30.9% and 17.9% respectively; P = 0.9). When the survival was analyzed using 4 different categories of BMI (underweight, normal, overweight and obese), a trend was seen toward a difference in survival, with a worse prognosis for the underweight and obese patients compared to normal weight and overweight patients. CONCLUSION Overweight increases the risk for intra-operative bleeding and PF, but do not otherwise alter short or long term outcome after PD for pancreatic cancer.

Patients’ perspectives of living with a percutaneous endoscopic gastrostomy (PEG)

BackgroundSince enteral nutrition therapy is the preferred nutritional support for dysphagic patients with a range of diagnoses, PEG has become part of traditional care. However, enteral nutrition with PEG transfers treatment responsibility and activity to the patients and their carers, so the advantages should be discussed. The aim of this study was therefore to investigate patients’ experience of living with a percutaneous endoscopic gastrostomy (PEG) in order to increase the understanding of patients’ need for support.MethodIn a prospective study at Karolinska University Hospital in Sweden, data were collected consecutively at the time of PEG and two months later using a study-specific questionnaire about each patient’s experience of living with a PEG. Fishers exact test was used to test for statistically significant difference at five per cent level.ResultsThere were 104 responders (response rate of 70%). Women felt more limited in daily activity compared to men (p = 0.004). Older patients experienced a more limited ability to influence the number of feeding times compared to younger (p = 0.026). Highly educated patients found feeding more time-consuming (p = 0.004). Patients with a cancer diagnosis reported that the PEG feeding interfered with their oral feeding more than patients with a neurological disease (p = 0.009). Patients mostly contacted the PEG outpatient clinic with problems regarding their PEG, and were mainly assisted by their spouse rather than district nurses.ConclusionsPEG feeding is time-consuming and interferes with daily life. Although 73% was satisfied, patients’ experiences of living with a PEG may be dependent on age, sex, education and diagnosis. Spouses are the main carers for PEG patients at home, and patients prefer to go to the PEG outpatient clinic for help if problems occur.

Losartan to prevent hyperenzymemia after endoscopic retrograde cholangiopan-creatography: A randomized clinical trial

AIM To study if the angiotensin II receptor blockers (ARB) losartan counteracts pancreatic hyperenzymemia as measured 24 h after endoscopic retrograde cholangiopancreatography (ERCP). METHODS A triple-blind and placebo-controlled randomized clinical trial was performed at two Swedish hospitals in 2006-2008. Patients over 18 years of age undergoing ERCP, excluding those with current pancreatitis, current use of ARB, and severe disease, such as sepsis, liver and renal failure. One oral dose of 50 mg losartan or placebo was given one hour before ERCP. The relative risk of hyperenzymemia 24 h after ERCP was estimated using multivariable logistic regression, and expressed as odds ratio with 95% confidence intervals (CIs), including adjustment for potential remaining confounding. RESULTS Among 76 participating patients, 38 were randomized to the losartan and the placebo group, respectively. The incidence rates of hyperenzymemia and acute pancreatitis among all 76 participating patients were 21% and 12%, respectively. Hyperenzymemia was detected in 9 and 7 patients in the losartan and placebo group, respectively. There were no major differences between the comparison groups regarding cannulation difficulty, findings, or proportion of patients requiring drainage of the bile ducts. There were, however, more pancreatic duct injections, a greater extent of pancreatography, and more biliary sphincterotomies in the losartan group than in the placebo group. Losartan was not associated with risk of hyperenzymemia compared to the placebo group after multi-varible logistic regression analysis (odds ratio 1.6, 95%CI 0.3-7.8). CONCLUSION In this randomized trial 50 mg losartan given orally had no prophylactic effect on development of hyperenzymemia after ERCP.

Phase angle as a prognostic marker after percutaneous endoscopic gastrostomy (PEG) in a prospective cohort study

ABSTRACT Objective: The phase angle identifies changes in tissue’s electrical properties assessed by bioelectrical impedance measurement and it can predict prognosis in some conditions. Percutaneous endoscopic gastrostomy (PEG) is commonly used in patients with severe nutritional problems, but there is a need to improve the clinical decision-making for using PEG. We examined if a decreased phase angle predicts complications, short-term mortality (within 60 days of PEG insertion), or inflammatory markers (high C-reactive protein [CRP] levels or low albumin levels) following PEG insertion. Material and methods: The phase angle was assessed from body resistance and reactance as measured by bioelectrical impedance in 131 patients admitted for PEG. Anthropometrics and clinical biochemical measures were collected at the time of PEG insertion, while complications and mortality were assessed at clinical follow-ups. Multivariable logistic regression analysis provided odds ratios (ORs) with 95% confidence intervals (CIs) adjusted for sex, age, body mass index, and comorbidity. Results: A decreased phase angle did not statistically significantly increase the probability of acute complications or short-term mortality, but predicted increased inflammatory markers (CRP ≥10 mg/L [OR 1.63, 95% CI 1.02–2.60], albumin <30 g/L [OR 2.10, 95% CI 1.24–3.57] and a combination of CRP ≥10 mg/L and albumin <30 g/L [OR 3.06, 95% CI 1.51–6.19]). Conclusions: A decreased phase angle did not predict acute complications or short-term mortality after PEG insertion, but predicted increased levels of inflammatory markers.

The Use of LigaSure™ Does not Affect Histologic Margin Assessment in Pancreatoduodenectomy (PD) Specimens

CONTEXT LigaSure™ is considered safe in performing pancreaticoduodenectomy (PD). However, no data are available regarding the possible damage of tissues at the resection margins and the impact thereof on histologic margin assessment. OBJECTIVE This study compares the degree of histologic damage to the resection margins when using LigaSure™ (Group 1) or traditional ligature (Group 2). METHODS Both groups included 8 consecutive patients who underwent PD at Karolinska Institute in December 2013 (Group 1) or earlier (Group 2) by the same surgeon (M.D.C.). The quality of tissues at the circumferential margins was compared between both groups by scoring for three different kinds of damage: tissue fragmentation, hemorrhage, and cell damage. RESULTS The mean score for fragmentation was 1.3 (Group 1) versus 1.7 (Group 2; P=0.1). For hemorrhage the mean score was 0.8 (Group 1) versus 1.5 (Group 2; P=0.04). The mean score for cell damage was 1.4 (Group 1) compared to 1.2 (Group 2; P=0.1). CONCLUSIONS LigaSure™ does not cause tissue damage that could affect histologic margin assessment in PD specimens.