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OBJECTIVE: To compare the long-term outcomes of immediate drainage versus the postponed-drainage approach in patients with infected necrotizing pancreatitis. BACKGROUND: In the randomized POINTER trial, patients assigned to the postponed-drainage approach using antibiotic treatment required fewer interventions, as compared with immediate drainage, and over a third were treated without any intervention. METHODS: Clinical data of those patients alive after the initial 6-month follow-up were re-evaluated. The primary outcome was a composite of death and major complications. RESULTS: Out of 104 patients, 88 were re-evaluated with a median follow-up of 51 months. After the initial 6-month follow-up, the primary outcome occurred in 7 of 47 patients (15%) in the immediate-drainage group and 7 of 41 patients (17%) in the postponed-drainage group (RR 0.87, 95% CI 0.33-2.28; P =0.78). Additional drainage procedures were performed in 7 patients (15%) versus 3 patients (7%) (RR 2.03; 95% CI 0.56-7.37; P =0.34). The median number of additional interventions was 0 (IQR 0-0) in both groups ( P =0.028). In the total follow-up, the median number of interventions was higher in the immediate-drainage group than in the postponed-drainage group (4 vs. 1, P =0.001). Eventually, 14 of 15 patients (93%) in the postponed-drainage group who were successfully treated in the initial 6-month follow-up with antibiotics and without any intervention remained without intervention. At the end of follow-up, pancreatic function and quality of life were similar. CONCLUSIONS: Also, during long-term follow-up, a postponed-drainage approach using antibiotics in patients with infected necrotizing pancreatitis results in fewer interventions as compared with immediate drainage and should therefore be the preferred approach. TRIAL REGISTRATION: ISRCTN33682933.
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Pancreatite Necrosante Aguda , Qualidade de Vida , Humanos , Resultado do Tratamento , Pancreatite Necrosante Aguda/complicações , Pancreatite Necrosante Aguda/cirurgia , Antibacterianos/uso terapêutico , Drenagem/métodosRESUMO
OBJECTIVE: To determine the nationwide use and outcome of tailored surgical treatment for symptomatic chronic pancreatitis (CP) as advised by recent guidelines. SUMMARY BACKGROUND DATA: Randomized trials have shown that surgery is superior to endoscopy in patients with symptomatic CP, although endoscopy remains popular Recent guidelines advice to "tailor surgery" based on pancreatic morphology meaning that the least extensive procedure should be selected based on pancreatic morphology. However, nationwide, and multicenter studies On tailored surgery for symptomatic CP are lacking. METHODS: Nationwide multicenter retrospective analysis of consecutive patients undergoing surgical treatment for symptomatic CP in all seven Dutch university medical centers (2010-2020). Outcomes included volume trend, major complications, 90-day mortality, postoperative opioid use and clinically relevant pain relief. Surgical treatment was tailored based on the size of the main pancreatic duct and pancreatic head (e.g. surgical drainage for a dilated pancreatic duct, and normal size pancreatic head). RESULTS: Overall, 381 patients underwent surgery for CP: 127 surgical drainage procedures ( 33%; mostly extended lateral pancreaticojejunostomy), 129 duodenum-preserving pancreatic head resections (DPPHR, 34%, mostly Frey), and 125 formal pancreatic resections (33%, mostly distal pancreatectomy). The annual surgical volume increased slightly (Pearson r=0.744). Mortality (90-day) occurred in 6 patients (2%), and was non-significantly lower after surgical drainage (0%, 3%, 2%; P =0.139). Major complications (12%, 24%, 26%; P =0.012), postoperative pancreatic fistula grade B/C (0%, 3%, 22%; P =0.038), surgical reintervention (4%, 16%, 12%; P =0.006), and endocrine insufficiency ( 14%, 21%, 43%; P <0.001) occurred less often after surgical drainage. After a median follow-up of 11 months [IQR 3-23] good rates of clinically relevant pain relief ( 83%, 69%, 80%; P =0.082) were observed and 81% of opioid users had stopped using (83%, 78%, 84%, P =0.496). CONCLUSION: The use of surgery for symptomatic CP increased over the study period. Drainage procedures were associated with the best safety profile and excellent functional outcome, highlighting the importance of tailoring surgery based on pancreatic morphology.
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INTRODUCTION: Chronic pancreatitis (CP) has a negative impact on quality of life (QoL). Because CP is a chronic condition, multiple assessments of QoL are required to obtain a thorough understanding of its impact on patients. Such studies are currently lacking. This study aims to gain insight into the course and predictors of QoL in patients with CP using prospective longitudinal data from a large cohort of patients. METHODS: Post hoc analysis of consecutive patients with definite CP registered in a prospective database between 2011 and 2019 in the Netherlands. Patient and disease characteristics, nutritional status, pain severity, medication usage, pancreatic function, and pancreatic interventions were assessed from medical records and through standard follow-up questionnaires. The physical and mental component summary scales of the Short-Form 36 were used to assess physical and mental QoL at baseline and during follow-up. The course of both physical and mental QoL and their associated factors were longitudinally assessed by using generalized linear mixed models. RESULTS: Overall, 1,165 patients with definite CP were included for this analysis. During 10-year follow-up, generalized linear mixed model analyses revealed improvements in both physical (41.6-45.2, P < 0.001) and mental (45.9-46.6, P = 0.047) QoL. Younger age, current alcohol consumption, employment, no need for dietetic consultation, no steatorrhea, lower Izbicki pain score, and pain coping mechanism were positively associated with physical QoL ( P < 0.05). For mental QoL, a positive correlation was found between employment, nonalcoholic CP, no need for dietetic consultation, no steatorrhea, lower Izbicki pain score, pain coping mechanism, and surgical treatment. No association was observed between disease duration and longitudinal QoL per patient. DISCUSSION: This nationwide study provides insight into the dynamics of physical and mental QoL in patients with CP over time. Important and potentially influenceable factors to improve QoL are nutritional status, exocrine pancreatic function, employment status, and patients' coping strategy.
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Pancreatite Crônica , Qualidade de Vida , Humanos , Estudos Longitudinais , Pancreatite Crônica/complicações , Dor/etiologia , Estudos de CoortesRESUMO
INTRODUCTION: Despite evidence-based guidelines, exocrine pancreatic insufficiency is frequently underdiagnosed and undertreated in patients with chronic pancreatitis. Therefore, the aim of this study is to provide insight into the current opinion and clinical decision-making of international pancreatologists regarding the management of exocrine pancreatic insufficiency. METHODS: An online survey and case vignette study was sent to experts in chronic pancreatitis and members of various pancreatic associations: EPC, E-AHPBA and DPSG. Experts were selected based on publication record from the past 5 years. RESULTS: Overall, 252 pancreatologists participated of whom 44% had ≥ 15 years of experience and 35% treated ≥ 50 patients with chronic pancreatitis per year. Screening for exocrine pancreatic insufficiency as part of the diagnostic work-up for chronic pancreatitis is performed by 69% and repeated annually by 21%. About 74% considers nutritional assessment to be part of the standard work-up. Patients are most frequently screened for deficiencies of calcium (47%), iron (42%), vitamin D (61%) and albumin (59%). In case of clinically steatorrhea, 71% prescribes enzyme supplementation. Of all pancreatologists, 40% refers more than half of their patients to a dietician. Despite existing guidelines, 97% supports the need for more specific and tailored instructions regarding the management of exocrine pancreatic insufficiency. CONCLUSION: This survey identified a lack of consensus and substantial practice variation among international pancreatologists regarding guidelines pertaining the management of exocrine pancreatic insufficiency. These results highlight the need for further adaptation of these guidelines according to current expert opinion and the level of available scientific evidence.
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Insuficiência Pancreática Exócrina , Pancreatite Crônica , Esteatorreia , Tomada de Decisão Clínica , Insuficiência Pancreática Exócrina/diagnóstico , Insuficiência Pancreática Exócrina/etiologia , Insuficiência Pancreática Exócrina/terapia , Humanos , Pâncreas , Pancreatite Crônica/complicações , Pancreatite Crônica/diagnóstico , Pancreatite Crônica/terapia , Esteatorreia/diagnóstico , Esteatorreia/etiologia , Esteatorreia/terapiaRESUMO
Pain is the most common symptom in chronic pancreatitis (CP) with a major impact on quality of life. Few validated questionnaires to assess pain in CP exist, and the lack of consensus negatively impacts clinical management, research and meta-analysis. This guideline aims to review generic pain questionnaires for their usability in CP, to outline how pain assessment can be modified by confounding factors and pain types, to assess the value of additional measures such as quality of life, mental health and quantitative sensory testing, and finally to review pain assessment questionnaires used specifically in CP. A systematic review was done to answer 27 questions that followed the PICO (Population; Intervention; Comparator; Outcome) template. Quality of evidence of the statements was judged by Grades of Recommendation, Assessment, Development and Evaluation (GRADE) criteria. The manuscript was sent for review to 36 experts from various disciplines and continents in a multi-stage Delphi process, and finally reviewed by patient representatives. Main findings were that generic pain instruments are valid in most settings, but aspects of pain are specific for CP (including in children), and instruments have to account for the wide phenotypic variability and development of sensitization of the central nervous system. Side effects to treatment and placebo effects shall also be considered. Some multidimensional questionnaires are validated for CP and are recommended together with assessment of quality of life and psychiatric co-morbidities. This guideline will result in more homogeneous and comprehensive pain assessment to potentially improve management of painful CP.
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Dor Abdominal , Dor Crônica , Medição da Dor , Pancreatite Crônica , Dor Abdominal/diagnóstico , Dor Abdominal/etiologia , Dor Abdominal/psicologia , Dor Crônica/diagnóstico , Dor Crônica/etiologia , Dor Crônica/psicologia , Consenso , Humanos , Medição da Dor/métodos , Pancreatite Crônica/complicações , Pancreatite Crônica/psicologia , Qualidade de Vida , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND OBJECTIVES: This study aims to investigate the specific complication rates, reconstructive differences, and delineate the pertinent independent risk factors in patients with different mastectomy weights. METHODS: A retrospective chart review of consecutive patients undergoing mastectomy between 2010 and 2015 was performed. Patient demographics, comorbidities, and intraoperative and postoperative outcomes were collected. Patients were divided into three groups: those with mastectomy weight <500, 500-1000, and >1000 g. RESULTS: During the study period, a total of 704 consecutive patients and 1041 total mastectomy surgeries had complete mastectomy specimen weight data. Of these, 437 breasts were in the <500 g specimen group, 425 were included in the 500-1000 g group and 179 in the >1000g group. The rate of overall complications between the three mastectomy weight groups (<500, 500-1000, and >1000 g) was statistically significant (14.0%, 17.6%, and 25.7%; P = 0.002, respectively) and were higher with increased mastectomy weights. Notably, in patients with breast mastectomy weight >1000 g, autologous reconstruction had significantly reduced rates of overall complications (AOR = 0.512, P = 0.048). CONCLUSION: Complication rates were lower in women with larger breast weights undergoing autologous reconstruction, warranting potential use of autologous free flap breast reconstruction in women with large mastectomy specimen weights when possible.
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Mama/anatomia & histologia , Mastectomia/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Mama/cirurgia , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mastectomia/efeitos adversos , Mastectomia/métodos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: Although approximately 57% of breast cancer (BC) diagnoses are in older patients (>60 years), only 4.1-14% receives breast reconstruction (BR). This has been attributed to physician concerns about operative complications. This paper aims to: 1) analyze the 30-day complication rates in the older patient population undergoing immediate breast reconstruction (IBR); and 2) analyze links between complication type and category of reconstruction. METHODS: Using the ACS-NSQIP database (2005-2014), all women older than 60 years of age diagnosed with BC and DCIS were identified. IBR and complication rates were plotted for all ages. Patients were divided into those with and those without complications. Patient demographics and co-morbidities were compared. Complications within each type of reconstruction were analyzed. RESULTS: Of the 4450 BC and 1104 DCIS patients, 22.3% (BC) and 20.9% (DCIS) had complications. IBR decreased significantly with increased age (P < 0.00 in both cohorts), while complication rates remained stable across all ages (P = 0.32 in BC, P = 0.69 in DCIS patients). Patients were well matched in terms of demographics. CONCLUSIONS: The rates of breast reconstruction decrease with increasing age. Despite increasing age, associated complication rates in IBR patients remained stable.
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Neoplasias da Mama/cirurgia , Mamoplastia , Complicações Pós-Operatórias/epidemiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Implantes de Mama , Carcinoma Ductal de Mama/cirurgia , Carcinoma Intraductal não Infiltrante/cirurgia , Bases de Dados Factuais , Feminino , Humanos , Mamoplastia/efeitos adversos , Pessoa de Meia-Idade , Estudos Retrospectivos , Transplante Autólogo , Estados Unidos/epidemiologiaRESUMO
INTRODUCTION: Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. METHODS: Multicentre prospective non-randomized pilot study including patients with moderate or severe pain (NRS ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5mg/kg, was followed by continuous infusion at 1.5 mg/kg/hour. The dose was raised every 15 minutes until treatment response (up to a maximum 2mg/kg/hour) and consecutively administered for two hours. Primary outcome was the mean difference in pain severity, pre-infusion and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥ 1.3 points was considered clinically relevant. RESULTS: Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day one was 1.1 (SD±1.3) points for patients with PDAC and 0.5 (SD±1.7) for CP patients. A clinically relevant decrease in BPI on day one was reported in 9/29 patients (31%), this response lasted up to one month. No serious complications were reported, and only three minor complications (vertigo, nausea, tingling of mouth). Treatment with lidocaine did not impact quality of life. CONCLUSION: Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group, and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.
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BACKGROUND: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP. METHODS: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial. DISCUSSION: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice. TRIAL REGISTRATION: ISRCTN, ISRCTN13042622. Registered on 5 September 2020.
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Pancreatite Crônica , Qualidade de Vida , Humanos , Pancreatite Crônica/diagnóstico , Pancreatite Crônica/terapia , Pâncreas , Dor , Estado Nutricional , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Heart failure is associated with decreased tissue perfusion and increased venous congestion that may result in organ dysfunction. This dysfunction has been investigated extensively for many organs, but data regarding pancreatic (exocrine) dysfunction are scarce. In the present review we will discuss the available data on the mechanisms of pancreatic damage, how heart failure can lead to exocrine dysfunction, and its clinical consequences. We will show that heart failure causes significant impairment of pancreatic exocrine function, particularly in the elderly, which may exacerbate the clinical syndrome of heart failure. In addition, pancreatic exocrine insufficiency may lead to further deterioration of cardiovascular disease and heart failure, thus constituting a true vicious circle. We aim to provide insight into the pathophysiological mechanisms that constitute this reciprocal relation. Finally, novel treatment options for pancreatic dysfunction in heart failure are discussed.
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Importance: Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and ß-cells, leading to impaired quality of life. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking. Objective: To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy. Design, Setting, and Participants: This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P < .05. Main Outcomes and Measures: The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring. Results: In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P = .03). In addition, the time spent in hypoglycemia (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P = .004). No serious adverse events occurred. Conclusions and Relevance: Patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings. Trial Registration: trialregister.nl Identifier: NL8871.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Pâncreas Artificial , Adulto , Glicemia , Automonitorização da Glicemia , Estudos Cross-Over , Feminino , Glucagon/efeitos adversos , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/tratamento farmacológico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial/efeitos adversos , Pancreatectomia , Penicilina G/uso terapêutico , Qualidade de VidaRESUMO
BACKGROUND: Umbilical reconstruction is an important component of deep inferior epigastric perforator (DIEP) flap breast reconstruction. This study evaluated the aesthetics of three different umbilical reconstruction techniques during DIEP flap breast reconstruction. METHODS: From January to April of 2013, a total of 29 consecutive patients undergoing DIEP flap breast reconstruction were randomized intraoperatively to receive one of three umbilicoplasty types: a diamond, an oval, or an inverted V incision. Independent plastic surgeons and members of the general public, identified using an online "crowdsourcing" platform, evaluated aesthetic outcomes in a blinded fashion. Reviewers were shown postoperative photographs of the umbilicus of all patients and a four-point Likert scale was used to rate the new umbilicus on the size, scar formation, shape, localization, and overall appearance. RESULTS: Results for the focus group of independent plastic surgeons and 377 members of the public were retrieved (n = 391). A total of 10 patients (34.5 percent) were randomized into having the diamond incision, 10 (34.5 percent) had the oval incision, and nine (31.0 percent) had the inverted V incision. Patients were well matched in terms of overall characteristics. The general public demonstrated a significant preference for the oval incision in all five parameters. There was no preference identified among surgeons. CONCLUSION: This study provides evidence that a sample of the U.S. general public prefers the aesthetics of the oval umbilicoplasty incision, which contrasted with the lack of preference identified within this focus group of plastic surgeons. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.