Development and external validation of a prediction model for tube feeding dependency for at least four weeks during chemoradiotherapy for head and neck cancer.

BACKGROUND & AIMS: Patients who receive chemoradiotherapy or bioradiotherapy (CRT/BRT) for locally advanced head and neck squamous cell carcinoma (LAHNSCC) often experience high toxicity rates interfering with oral intake, causing tube feeding (TF) dependency. International guidelines recommend gastrostomy insertion when the expected use of TF exceeds 4 weeks. We aimed to develop and externally validate a prediction model to identify patients who need TF ≥ 4 weeks and would benefit from prophylactic gastrostomy insertion. METHODS: A retrospective multicenter cohort study was performed in four tertiary head and neck cancer centers in the Netherlands. The prediction model was developed using data from University Medical Center Utrecht and the Netherlands Cancer Institute and externally validated using data from Maastricht University Medical Center and Radboud University Medical Center. The primary endpoint was TF dependency ≥4 weeks initiated during CRT/BRT or within 30 days after CRT/BRT completion. Potential predictors were extracted from electronic health records and radiotherapy dose-volume parameters were calculated. RESULTS: The developmental and validation cohort included 409 and 334 patients respectively. Multivariable analysis showed predictive value for pretreatment weight change, texture modified diet at baseline, ECOG performance status, tumor site, N classification, mean radiation dose to the contralateral parotid gland and oral cavity. The area under the receiver operating characteristics curve for this model was 0.73 and after external validation 0.62. Positive and negative predictive value for a risk of 90% or higher for TF dependency ≥4 weeks were 81.8% and 42.3% respectively. CONCLUSIONS: We developed and externally validated a prediction model to estimate TF-dependency ≥4 weeks in LAHNSCC patients treated with CRT/BRT. This model can be used to guide personalized decision-making on prophylactic gastrostomy insertion in clinical practice.

Esophageal Atresia and Associated Duodenal Atresia: A Cohort Study and Review of the Literature.

INTRODUCTION: Esophageal atresia (EA) is associated with duodenal atresia (DA) in 3 to 6% of cases. The management of this association is controversial and literature is scarce on the topic. MATERIALS AND METHODS: We aimed to (1) review the patients with EA + DA treated at our institution and (2) systematically review the English literature, including case series of three or more patients. RESULTS: Cohort study: Five of seventy-four patients with EA had an associated DA (6.8%). Four of five cases (80%) underwent primary repair of both atresia, one of them with gastrostomy placement (25%). One of five cases (20%) had a delayed diagnosis of DA. No mortality has occurred. Systematic Review: Six of six-hundred forty-five abstract screened were included (78 patients). Twenty-four of sixty-eight (35.3%) underwent primary correction of EA + DA, and 36/68 (52.9%) underwent staged correction. Nine of thirty-six (25%) had a missed diagnosis of DA. Thirty-six of sixty-eight underwent gastrostomy placement. Complications were observed in 14/36 patients (38.9 ± 8.2%). Overall mortality reported was 41.0 ± 30.1% (32/78 patients), in particular its incidence was 41.7 ± 27.0% after a primary treatment and 37.0 ± 44.1% following a staged approach. CONCLUSION: The management of associated EA and DA remains controversial. It seems that the staged or primary correction does not affect the mortality. Surgeons should not overlook DA when correcting an EA.

Endoscopic Enteral Access.

Various approaches for enteral access exist, but because there is no single best approach it should be tailored to the needs of the patient. This article discusses the various enteral access techniques for nasoenteric tubes, gastrostomy, gastrojejunostomy, and direct jejunostomy as well as their indications, contraindications, and pitfalls. Also discussed is enteral access in altered anatomy. In addition, complications associated with these endoscopic techniques and how to either prevent or properly manage them are reviewed.

Percutaneous endoscopic gastrostomy - Too often? Too late? Who are the right patients for gastrostomy?

Percutaneous endoscopic gastrostomy is an established method to provide nutrition to patients with restricted oral uptake of fluids and calories. Here, we review the methods, indications and complications of this procedure. While gastrostomy can be safely and easily performed during gastroscopy, the right patients and timing for this intervention are not always chosen. Especially in patients with dementia, the indication for and timing of gastrostomies are often improper. In this patient group, clear data for enteral nutrition are lacking; however, some evidence suggests that patients with advanced dementia do not benefit, whereas patients with mild to moderate dementia might benefit from early enteral nutrition. Additionally, other patient groups with temporary or permanent restriction of oral uptake might be a useful target population for early enteral nutrition to maintain mobilization and muscle strength. We plead for a coordinated study program for these patient groups to identify suitable patients and the best timing for tube implantation.

Report on the impact of a service improvement programme in a well-established radiologically inserted gastrostomy service.

BACKGROUND: The present study aimed to evaluate whether the implementation of a service improvement programme improved the occurrence of radiologically inserted gastrostomy (RIG) tube displacements, post-insertion. METHODS: A retrospective observational study of cancer patients was conducted over a 2-year period divided into two time points. Eighty-two RIG insertions were audited retrospectively; 42 in Time 1 and 40 in Time 2. RESULTS: Some 70% (n = 57) of patients had head and neck (H&N) malignancy, 24% (n = 20) had gastrointestinal cancer and 6% (n = 5) had a variety of other malignancies. Following the implementation of the service improvement programme, the number of RIG tube displacements almost halved from nine (21%) to five (12%). CONCLUSIONS: The present study offers persuasive evidence indicating that the implemented service improvement programme improved patient care; however, further research incorporating a more robust evaluation is necessary. People with advanced disease are living longer and so there is a need to maintain good nutritional support. This innovation offers the potential to enhance patients' quality of care and minimise complications.

Safety, Efficacy, and Cost-Analysis of Percutaneous Endoscopic Gastrostomy and Ventriculoperitoneal Shunt Placement in a Simultaneous Surgery.

BACKGROUND: Limited historical data suggest that concomitant placement of both a ventriculoperitoneal (VP) shunt and percutaneous endoscopic gastrostomy (PEG) tube is associated with an increased risk of complications, including VP shunt infections. Here we compare the outcomes and cost difference between 2 groups of patients, one in which a VP shunt and PEG tube were placed in the same operation and the other in which separate operations were performed. METHODS: A total of 10 patients underwent simultaneous placement of a VP shunt and PEG tube. This group was compared with a group of 18 patients that underwent separate placements. Hospital billing charges were used to compare the total cost of the procedures in the 2 groups. RESULTS: Eight of the 10 patients presented with aneurysmal subarachnoid hemorrhage. The average length of stay was 25 ± 2 days for the simultaneous procedure group and 43 ± 7 days for the separate procedures group. The average duration of follow-up was 12 ± 3 months after simultaneous placement. No patient in the simultaneous surgery group had signs of infection or shunt malfunction at last follow-up. The overall complication rate was significantly lower in the simultaneous surgery group. A cost analysis demonstrated significant cost savings by completing both procedures in the same surgical procedure. CONCLUSIONS: Simultaneous placement of a PEG tube and VP shunt is safe, efficacious, and cost-effective. Thus, in patients requiring both a VP shunt and PEG tube, placement of both devices in a single surgical procedure should be considered.

A Pilot Study to Evaluate Compliance with Guidelines for Preprocedural Reconsideration of Code Status Limitations.

BACKGROUND: Periprocedural providers are encountering more patients with code status limitations (CSLs) regarding their preferences for resuscitation and life-sustaining treatment who choose to undergo palliative procedures. Surgical and anesthesia guidelines for preprocedural reconsideration of CSLs have been available for several years, but it is not known whether they are being followed in practice. OBJECTIVE: We assessed compliance with existing guidelines for patients undergoing venting gastrostomy tube (VGT) for malignant bowel obstruction (MBO), serving as an example of a palliative procedure received by patients near the end of life. DESIGN: Code status was determined at admission and throughout the hospitalization by chart review. Documentation of code status discussions (CSDs) was identified from provider notes and compared with existing guidelines. SETTING/SUBJECTS: An institutional database retrospectively identified patients who underwent VGT placement for MBO at two academic hospitals (2014-2015). MEASUREMENTS: We identified 53 patients who underwent VGT placement for MBO. Interventional radiologists performed 88% of these procedures. Other periprocedural providers involved in these cases included surgeons, gastroenterologists, anesthesiologists, and sedation nurses. RESULTS: CSLs were documented before the procedure in only 43% of cases, and a documented CSD with a periprocedural provider was identified in only 22% of CSL cases. Of all VGT placements performed in patients with CSLs before the procedure, only 13% were compliant with the guidelines of preprocedural reconsideration of CSLs. CONCLUSIONS: Increased compliance with guidelines published by the American Society of Anesthesiologists, the American College of Surgeons, and the Association of Perioperative Registered Nurses is necessary to ensure goal-concordant care of patients with CSLs who undergo a procedure. Efforts should be made to incorporate these guidelines into the training of all periprocedural providers.

Comparison of Nutritional and Clinical Outcomes in Patients with Head and Neck Cancer Undergoing Chemoradiotherapy Utilizing Prophylactic versus Reactive Nutrition Support Approaches.

BACKGROUND: The optimal method of tube feeding for patients with head and neck cancer remains unclear. A validated protocol is available that identifies high-nutritional-risk patients who would benefit from prophylactic gastrostomy tube placement. Adherence to this protocol is ultimately determined by clinical team discretion or patient decision. OBJECTIVE: The study aim was to compare outcomes after adherence and nonadherence to this validated protocol, thus comparing a prophylactic and reactive approach to nutrition support in this patient population. DESIGN: We conducted a prospective comparative cohort study. Patients were observed during routine clinical practice over 2 years. PARTICIPANTS/SETTING: Patients with head and neck cancer having curative-intent treatment between August 2012 and July 2014 at a tertiary hospital in Queensland, Australia, were included if assessed as high nutrition risk according to the validated protocol (n=130). Patients were grouped according to protocol adherence as to whether they received prophylactic gastrostomy (PEG) per protocol recommendation (prophylactic PEG group, n=69) or not (no PEG group, n=61). MAIN OUTCOME MEASURES: Primary outcome was percentage weight change during treatment. Secondary outcomes were feeding tube use and hospital admissions. STATISTICAL ANALYSIS PERFORMED: Fisher's exact, χ2, and two sample t tests were performed to determine differences between the groups. Linear and logistic regression were used to examine weight loss and unplanned admissions, respectively. RESULTS: Patients were 88% male, median age was 59 years, with predominantly stage IV oropharyngeal cancer receiving definitive chemoradiotherapy. Statistically significantly less weight loss in the prophylactic PEG group (7.0% vs 9.0%; P=0.048) and more unplanned admissions in the no PEG group (82% vs 75%; P=0.029). In the no PEG group, 26 patients (43%) required a feeding tube or had ≥10% weight loss. CONCLUSIONS: Prophylactic gastrostomy improved nutrition outcomes and reduced unplanned hospital admissions. Additional investigation of characteristics of patients with minimal weight loss or feeding tube use could help refine and improve the protocol.

[Comparison of safety insertion techniques of percutaneous endoscopic gastrostomy in nurses and physicians - a non-randomized interventional pilot study on a simulation model]. / Vergleich der Sicherheit der perkutan gastralen Punktion im Rahmen der PEG-Anlage zwischen Ärzten und spezialisierten Pflegenden ­ eine nicht randomisierte, interventionelle Pilotstudie an Simulatoren.

Percutaneous endoscopic gastrostomy (PEG) insertion represents a standardized procedure for enteral nutrition in patients with long-term eating difficulties for various reasons. In a clinical setting, delegation of stomach puncture and placement of a PEG tube, within the context of percutaneous endoscopic gastrostomy amongst nurses, occurs. In Germany, there are no studies yet showing the differences between physicians and nurses regarding the safety of percutaneous stomach puncture.In a non-randomized quasi-experimental interventional study on a simulation model, the safety of stomach puncture within the context of percutaneous endoscopic gastrostomy between physicians and nurses with special training was compared. Technical skills were recorded with video cameras and provided the basis for the following analysis. The study contained: (1) a theoretical preparation phase, (2) training on simulation model and a repeated practice of the skills, and (3) stomach puncture on the simulation model. The actions were recorded with a multichannel video technique. As part of the concept, nurses and physicians were trained together in theory and practice. The analysis was conducted with the newly designed Assessment Instrument Percutaneous Endoscopic Gastrostomy (AS-PEG). Seven physicians and 17 nurses took part in the pilot study. On average, the physicians reached a score of 36.4 ±â€Š2.2 (33 - 39) and nurses 37.4 ±â€Š2 (32 - 40), while the maximum score was 42. The evaluation of technical skills on the recorded videos by means of Assessment Instrument Percutaneous Endoscopic Gastrostomy (AS-PEG) showed no tendency to significant differences between physicians and nurses after theoretical and practical training. The study contributes a first objective evaluation of technical skills on stomach puncture within the context of percutaneous endoscopic gastrostomy with the newly designed AS-PEG.

Review of the Effectiveness of Enteral Feeding in Pediatric Oncology Patients [Formula: see text].

Enteral supplementation for nutritional support in pediatric oncology patients remains nonstandardized across institutions and between providers. Pediatric oncology patients frequently fail to meet their growth curve percentiles, lose weight, and/or are malnourished due to both the oncologic process as well as side effects from chemotherapy and radiation treatments. Methods of increasing weight include enteral feeding (nasogastric, nasoduodenal/jejunal, or gastrostomy), parenteral intravenous feeding, and oral supplementation. Indications for feeding and feeding protocols are highly variable, in part due to parental and familial choices, and in part due to the lack of guidelines available for providers. This article provides a comprehensive literature review of 8 published studies regarding the effectiveness and safety of enteral feeding in maintaining or increasing weight in pediatric oncology patients to help inform practice. The review concludes that enteral feeding in pediatric oncology patients is an effective and safe method to affect weight positively. However, further research is needed for developing treatment guidelines, including establishing a timeline for initiation of feeding, and determining which patients are most likely to benefit from enteral feeding.

Case Volume and Revisits in Children Undergoing Gastrostomy Tube Placement.

OBJECTIVES: Emergency department (ED) visits and hospital readmissions are common after gastrostomy tube (GT) placement in children. We sought to characterize interhospital variation in revisit rates and explore the association between this outcome and hospital-specific GT case volume. PATIENTS AND METHODS: We conducted a retrospective cohort study from 38 hospitals using the Pediatric Health Information System database. Patients younger than 18 years who had a GT placed in 2010 to 2012 were assessed for a GT-related (mechanical or infectious) ED visit or inpatient readmission at 30 and 90 days after discharge from GT placement. Risk-adjusted rates were calculated using generalized linear mixed-effects models accounting for hospital clustering and relevant demographic and clinical attributes, then compared across hospitals. RESULTS: A total of 15,642 patients were included. A median of 468 GTs were placed in all the 38 hospitals during 3 years (range: 83-891), with a median of 11.4 GT placed per 1000 discharges (range: 2.4-16.7). Median ED visit for each hospital at 30 days after discharge was 8.2% (range: 3.7%-17.2%) and 14.8% at 90 days (range: 6.3%-26.1%). Median inpatient readmissions for each hospital at 30 days after discharge was 3.5% (range: 0.5%-10.5%) and 5.9% at 90 days (range: 1.0%-18.5%). Hospital-specific GT placement per 1000 discharges (rate of GT placement) was inversely correlated with ED visit rates at 30 (P = 0.007) and 90 days (P = 0.020). The adjusted 30- and 90-day readmission rate and the adjusted 30- and 90-day ED return rates decreased with increasing GT insertion rate (P < 0.001). CONCLUSION: Higher hospital GT insertion rates are associated with lower ED revisit rates but not inpatient readmissions.

Practice Patterns of Percutaneous Endoscopic Gastrostomy Tube Placement in Acute Stroke: Are the Guidelines Achievable?

OBJECTIVES: Our objectives were to evaluate trends in percutaneous endoscopic gastrostomy (PEG) tube placement rate and timing in acute stroke patients. We hypothesized that noncompliance with clinical practice guidelines for timing of tube placement and an increase in placement occurred because of a decrease in length of hospital stay. METHODS: We conducted a retrospective observational study of archival hospital billing data from the Florida state inpatient healthcare cost and utilization project database from 2001 to 2012 for patients with a primary diagnosis of stroke. Outcome measures were timing of PEG tube placements by year (2006-2012), rate of placements by year (2001-2012), and length of hospital stay. Univariate analyses and simple and multivariable logistic regression analyses were conducted. RESULTS: The timing of gastrostomy tube placement remained stable with a median of 7 days post admission from 2006 through 2012. The proportion of tubes that were placed at or after 14 days and thereby met the guideline recommendations varied from 14.09% in 2006 to 13.41% in 2012. The rate of tube placement in stroke patients during the acute hospital stay decreased significantly by 25% from 6.94% in 2001 to 5.22% in 2012 (P < .0001). The length of hospital stay for all stroke patients decreased over the study period (P < .0001). CONCLUSIONS: The vast majority of PEG tube placements happen earlier than clinical practice guidelines recommend. Over the study period, the rate of tubes placed in stroke patients decreased during the acute hospital stay despite an overall reduced length of stay.

Advances in Pediatric Gastrostomy Placement.

Placement of gastrostomy tubes in infants and children has become increasingly commonplace. A historical emphasis on use of open gastrostomy has been replaced by less invasive methods of placement, including percutaneous endoscopic gastrostomy and laparoscopically assisted gastrostomy procedures. Various complications, ranging from minor to the more severe, have been reported with all methods of placement. Many pediatric patients who undergo gastrostomy tube placement will require long-term enteral therapy. Given the prolonged time pediatric patients may remain enterally dependent, further quality improvement and education initiatives are needed to improve long-term care and outcomes of these patients.

Reducing Accidental Dislodgement of the Percutaneous Endoscopic Gastrostomy: A Prospective Trial of the "SafetyBreak" Device.

BACKGROUND: The percutaneous endoscopic gastrostomy (PEG) is a ubiquitous feeding tube with high rates of accidental dislodgement, with significant morbidity and health care costs. We hypothesized use of a decoupling device is a safe and effective mechanism to reduce dislodgements. STUDY DESIGN: We studied a prospective cohort of 100 patients from an academic center. Enrollment included patients requiring PEG tube placement with follow up extending through an individual's lifetime use of their PEG tube. The primary endpoint was accidental dislodgement of the principally placed PEG tube. The secondary endpoint was time to accidental dislodgement of the PEG tube. RESULTS: All 100 patients received the SafetyBreak device and had complete follow-up. Half of the patients had at least a single episode of device decoupling, indicating prevention of dislodgement of the PEG. Eight patients ultimately had dislodgement, resulting in a significantly lower dislodgement rate when compared with a historical cohort (P = .036) and significantly longer survival of the PEG (log rank = 0.005). When compared with a concurrent cohort (without the device) there was also significantly lower dislodgement rate (P = .03) and a trend toward longer survival of the PEG (log rank = 0.08). CONCLUSIONS: When compared with both a historical and concurrent cohort of patients, the SafetyBreak device reduces accidental dislodgement of PEG tubes. As an increasing number of PEGs are being placed, an increasing number of patients are at risk for dislodgement. The SafetyBreak device is an innovative, economical solution to the problem of accidental dislodgement of the PEG tube.

Patient-centered care and quality: Activating the system and the patient.

Patient-centered care is an expectation in our current environment, yet it is only one of the six domains that the Institute of Medicine has described as critical in redesigning the architecture of a medical system. Patients requiring long-term feeding tube access represent a particularly complex group of patients who stress the mechanisms placed within a healthcare system to optimize quality and safety. We describe the implementation of a new approach to this patient population that serves as an example of redesigning a system of care to optimize safety using the principles of patient-centered care while delivering safe, effective, timely, efficient, and equitable care.

Endoscopic ultrasonography guided drainage: summary of consortium meeting, May 21, 2012, San Diego, California.

Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred procedure for biliary and pancreatic drainage. While ERCP is successful in about 95% of cases, a small subset of cases are unsuccessful due to altered anatomy, peri-ampullary pathology, or malignant obstruction. Endoscopic ultrasound-guided drainage is a promising technique for biliary, pancreatic and recently gallbladder decompression, which provides multiple advantages over percutaneous or surgical biliary drainage. Multiple retrospective and some prospective studies have shown endoscopic ultrasound-guided drainage to be safe and effective. Based on the currently reported literature, regardless of the approach, the cumulative success rate is 84%-93% with an overall complication rate of 16%-35%. endoscopic ultrasound-guided drainage seems a viable therapeutic modality for failed conventional drainage when performed by highly skilled advanced endoscopists at tertiary centers with expertise in both echo-endoscopy and therapeutic endoscopy.

Experience of gastrostomy using a quality care framework: the example of rett syndrome.

Rett syndrome is one of many severe neurodevelopmental disorders with feeding difficulties. In this study, associations between feeding difficulties, age, MECP2 genotype, and utilization of gastrostomy were investigated. Weight change and family satisfaction following gastrostomy were explored. Data from the longitudinal Australian Rett Syndrome Database whose parents provided data in the 2011 family questionnaire (n=229) were interrogated. We used logistic regression to model relationships between feeding difficulties, age group, and genotype. Content analysis was used to analyze data on satisfaction following gastrostomy. In those who had never had gastrostomy and who fed orally (n=166/229), parents of girls<7 years were more concerned about food intake compared with their adult peers (odds ratio [OR] 4.26; 95% confidence interval [CI] 1.29, 14.10). Those with a p.Arg168 mutation were often perceived as eating poorly with nearly a 6-fold increased odds of choking compared to the p.Arg133Cys mutation (OR 5.88; 95% CI 1.27, 27.24). Coughing, choking, or gagging during meals was associated with increased likelihood of later gastrostomy. Sixty-six females (28.8%) had a gastrostomy, and in those, large MECP2 deletions and p.Arg168 mutations were common. Weight-for-age z-scores increased by 0.86 (95% CI 0.41, 1.31) approximately 2 years after surgery. Families were satisfied with gastrostomy and felt less anxious about the care of their child. Mutation type provided some explanation for feeding difficulties. Gastrostomy assisted the management of feeding difficulties and poor weight gain, and was acceptable to families. Our findings are likely applicable to the broader community of children with severe disability.

Nutrition outcomes following implementation of validated swallowing and nutrition guidelines for patients with head and neck cancer.

PURPOSE: Head and neck cancer patients have a high risk of malnutrition and swallowing dysfunction. This study reports on adherence and nutrition outcomes with the use of local evidence-based guidelines for the nutrition management of patients with head and neck cancer, including placement of proactive gastrostomy tubes for high risk patients. METHODS: This study is a prospective observational audit in patients treated for head and neck cancer at a tertiary hospital from 2007 to 2008 (n = 539). Nutrition outcomes (weight, nutritional status and type of nutrition support) were compared for each nutrition risk category. Primary outcome was 10 % or more weight loss at 3 months post-treatment (n = 219). RESULTS: Overall adherence to the guideline tube feeding recommendations was 81 %. High risk patients had mean weight loss of 6 % on completion of treatment and 9 % at 3 months post-treatment, despite the majority having a proactive gastrostomy tube. Medium and low risk patients also lost weight over this time. Univariate analysis found that non-adherence to the guidelines was associated with weight loss at 3 months (p = 0.013). Multivariate analysis found overweight patients had 1.82 greater odds, and obese patients had 3.49 greater odds of losing weight (p = 0.021). Patients with significant weight loss at diagnosis had decreased odds of losing weight later (p = 0.011). CONCLUSION: Clinically significant weight loss was still prevalent in this population despite proactive interventions. Predictors of weight loss support the evidence-based guidelines' risk categories, and adherence was important to improve outcomes. Further research is required to determine the impact of significant weight loss in patients with high body mass index (BMI).