Helpful Position Paper: Percutaneous Endoscopic Gastrostomy in Children

A recent European Society for Pediatric Gastroenterology Hepatology and Nutrtition (ESPGHAN) position paper provides some useful advice regarding the management of percutaneous endoscopic gastrostomy (PEG) in children and adolescents (JPGN 2015; 60: 131-41).

Table 1 provides a succinct description of the potential benefits of PEG compared with nasogastric tube including less dislodgement, reduces risk of aspiration, better appearance, safer/more reliable enteral access, optimizes development of oral skills, less blockage/clogging, cost-effective, less interference with daily activities, avoids nasal irritation/trauma, reduced anxiety at mealtimes, and shorter meal times.

Table 2 provides a good summary of clinical indications including optimizing nutritional status, maintaining hydration, supporting unpalatable diet, decompressing stomach, improving medication adherence, ensuring safe feedings/prevent aspiration, and improving quality of life.

The position paper reviews relative and absolute contraindications (uncorrectable coagulopathy, interposition of enlarged organs, frank peritonitis); I did not see any mention of high dose steroids as a relative contraindication.  Given high dose steroids’ impact on healing, PEG needs to be avoided if possible in this setting (in my opinion).

The authors provide extensive information on potential complications (table 6 and table 7).

Other key points:

  • “In the United Kingdom, it is accepted by the National Institute of Clinical Effectiveness that expectation of continuous NGT use for a minimum of 4 weeks (www.nice.org.uk/CG032 –this reference provided by authors focuses on NGT in adults), or even 2 to 3 weeks, should prompt consideration of PEG insertion.”
  • “The use of a routine preoperative upper GI contrast study is NOT advised to rule out malrotation.”
  • “Asymptomatic children do not require investigation for GERD before PEG insertion.” However, the authors note that in the presence of significant symptomatic reflux, or reflux in the presence of an unsafe swallow/progressive neurologic disease, or chronic respiratory disease, this should prompt discussion around the need for a surgical antireflux procedure.
  • The authors suggest that PEG change to a button can occur “after a period of 2 months or more.” Our institution generally does not change prior to 3 months.
  • The authors state that formula (rather than clears) can be started within 4 to 6 hours of PEG insertion.
  • One aspect of their recommendations that I disagreed with was their advice on preventing a ‘buried bumper.’  “To prevent a ‘buried bumper,’ the PEG should be carefully pushed into the stomach by 1 to 2 cm and then rotated once a week from day 7 postinsertion.”
  • Perhaps this advice is offered as the guideline also suggests that patients do not need much follow-up: “The child will require follow-up, typically provided by nurse specialists 3 months after placement of the gastrostomy.  Thereafter, annual review of the device is usually adequate…between routine appointments caregivers should have access to appropriately trained professionals.”  In my view, if the tube is appropriately sized (checked early on) and patients are followed (for excessive weight gain), then pushing in the tube should be unnecessary.

Take-home message: Overall, this is a useful reference/summary for PEG tube management, though some recommendations are based on practice patterns rather than high-quality data.

Are there others who would like to relay their experience and advice?

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Not Happy With Functional GI Diseases

A recent study (J Pediatr 2015; 166: 85-90, editorial 11-14) finds that children with functional gastrointestinal diseases (FGID) had more impaired “quality of life” than children with organic gastrointestinal diseases.  For those of us taking care of these children, this finding does not come as a surprise, but there is a lot to learn from this study nonetheless.

Using the Pediatric Quality of Life Inventory 4.0 Generic Core Scales, the authors completed a 9-site study with 689 families for patients with physician-diagnosed GI disorders including functional problems like irritable bowel syndrome and dyspepsia as well as organic diseases like Crohn’s disease and ulcerative colitis.  These patients were compared with a healthy control sample of 1114 families.

In addition to obtaining health-related quality of life (HRQOL) data, the authors reported information on school days missed, days in bed, parent missed workdays, and healthcare utilization.

Key findings:

  • FGID and organic GI diseases demonstrated lower HRQOL than healthy controls across all measures (emotional, physical, social, and school; P<0.001 for all) with larger effect sizes for FGID.
  • FGID and organic GI diseases also had more school days missed, days in bed, parent missed workdays, and healthcare utilization, again with larger effect sizes for FGID.

The associated editorial tries to work through the reasons why the impact of FGID is greater than an organic disease.

The authors hypothesize that two factors play a big role:

1. Issue of control:

  • FGID -the cause is less evident
  • FGID -very few effective treatments
  • These factors may contribute to families feeling helpless and ‘out of control’

2. Issue of response shift:

  • The authors explain that response shift indicates a circumstance in which a “patient is compelled to adjust to this new reality.”
  • Response shift often involves a change in expectations
  • Response shift often involves a change in prioritization
  • Thus, response shift could explain why patients with organic GI disease have higher quality of life scores.

In addition, the authors note that with many FGID, that physicians often “suspect constipation is the cause…when laxative therapy is not helpful, this leads to more frustration.”  They advocate shifting the focus for these families from “finding a cure to managing day-to-day symptoms.”

In my view, there are a lot of other factors at play that may help explain why HRQOL is lower in patients with FGIDs. This can include a high incidence of emotional disturbances (eg. anxiety, depression) and poor coping skills (eg. catastrophizing).  This study also is another example showing that the physical severity of the medical disease does not correlate with the severity of the impact.

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Will I Have This Stomach Pain Forever? (Part 2)

The article reviewed earlier today on this blog (Clinical Gastroenterology and Hepatology 2014; 12: 2026-32) has been reviewed on the AGA blog as well (some of this information is redundant from earlier post):

Here’s a link to a summary of the article: AGA blog on RAP and here’s an excerpt: Sara Horst et al investigated whether pediatric functional abdominal pain leads to functional gastrointestinal disorders (FGIDs) such as irritable bowel syndrome (IBS) in adulthood. They performed a longitudinal analysis of 392 children (8−16 years old) initially seen at a subspecialty clinic for recurrent abdominal pain. Horst et al assessed the contribution of gastrointestinal symptoms, extra-intestinal somatic symptoms, and depressive symptoms to FGIDs 5−15 years later. They found that on average 9 years later, 41% met symptom criteria for FGID—mostly irritable bowel syndrome and functional dyspepsia. Levels of depressive symptoms in childhood correlated a greater likelihood of FGID later in life (see figure).   The probability of FGID in adolescence or young adulthood increases with each increase in Children's Depression Inventory (CDI) score up to a score of 13—the cut-off point used in screening children for depression. At CDI scores higher than 13, the probability of FGID remained fairly constant.

Will I Have This Stomach Pain Forever? (Part 1)

More data (Clin Gastroenterol Hepatol 2014; 12: 2026-32) helps answer the question about the persistence of functional abdominal pain from childhood into young adulthood.

Using a longitudinal study design, consecutive new pediatric patients (8-16 years) with functional abdominal pain from a subspecialty clinic were contacted on average 9.2 years (n=392) after their initial evaluation.

Key findings:

  • 41% continue to meet criteria for a functional GI disorder, most commonly irritable bowel syndrome (110 of 169 patients).
  • Severity of pain was not a predictive factor of persistence
  • Extraintestinal somatic complaints and depressive symptoms increased the risk of having persistent functional abdominal pain.

The associated editorial (pages 2033-36) comments on the strengths of the study and the potential opportunity of intervening to prevent persistence of abdominal pain.  It notes that anxiety and hypervigilance can lower the brain’s perception threshold and lead to increased pain.  “From this perspective, centrally targeted treatments such as psychological treatment or psychopharmacological treatments will likely have therapeutic value.”

Take-home message: 59% of patients resolve their symptoms with time.

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What’s Wrong with “I Want My Kid Tested For Food Allergies”

Most parents, and many physicians, do not understand the limitations of food allergy testing.  As I am sure is common among physicians, I frequently receive requests for food allergy testing; parents do not realize that the strategy for food allergy testing is not straight-forward and has not advanced significantly for decades.  This information is detailed in a recent study and associated editorial (J Pediatr 2015; 166: 97-100, editorial 8-10: “Pitfalls in Food Allergy”).

The study was a retrospective review of all new patients seen at a pediatric food allergy center (2011-2012).  This involved a review of 797 new patients.

Key findings:

  • Of 284 patients who had received a food allergy panel, only 90 (32.8%) had a history warranting evaluation for food allergy.
  • Among 126 individuals who had food restrictions imposed based on food allergy panel testing, 112 (88.9%) were able to re-introduce at least 1 food into their diet.
  • The positive predictive value of food allergy testing was 2.2%.

So what can we learn from this study and editorial?

Misdiagnosis often relates to a lack of understanding regarding serum IgE-based testing.  First of all, many children with atopic dermatitis (and other atopic conditions) have elevated total IgE which results in more false positives.  In addition, a positive IgE test for a specific food indicates sensitization but not necessarily an allergy.

Strategy for testing (recommended by editorial):

  • “The key to the diagnosis of food allergy cannot be overstated; it begins with a detailed clinical history”
  • Testing should be “limited in general to the food(s) in question.”
  • When there is uncertainty, oral food challenges can be performed by specialists.
  • “If a patient is consuming a food without clinical symptoms of allergy, allergy testing should not be done to that food.”

Bottomline (from authors’ conclusion): “Food allergy panel testing often results in misdiagnosis of food allergy, overly restrictive dietary avoidance, and an unnecessary economic burden on the health system.”

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Infliximab -Low Response in Young Kids (7 years and younger) with IBD

 JPGN 2014; 59: 758-62. The full abstract for this reference follows but the message from this retrospective study of 33 children is clear –a much smaller percentage of the youngest children respond to infliximab compared to older children, adolescents and adults. In the discussion, the authors note that younger children may need higher dosing to maintain good infliximab levels or the disease pathogenesis may be much different (eg. underlying immunodeficiency and different gene mutations).

Here’s the abstract (from JPGN twitter feed):

Background: Infliximab (IFX) is efficacious for induction and maintenance of remission in pediatric patients with moderate-to-severe inflammatory bowel disease (IBD). It has, however, not been studied in patients 7 years old and younger. Our aim was to characterize efficacy and safety of IFX therapy in this cohort.

Methods: This was a retrospective study of patients with IBD ages 7 years and younger, treated with IFX between 1999 and 2011. Medical records were reviewed for age of diagnosis, disease phenotype, therapy, surgery, IFX infusion dates, dose, and intervals. Outcome measures included physician global assessment, corticosteroid requirement, and adverse events.

Results: Thirty-three children (ages 2.4–7 years) were included. Twenty patients had Crohn disease, 4 had ulcerative colitis, and 9 had indeterminate colitis. Maintenance of IFX therapy at 1, 2, and 3 years was 36%, 18%, and 12%, respectively. Patients of age 5 years and younger had the lowest rates of maintenance of therapy at 25% at year 1, and 10% at years 2 and 3 combined. Nine percent of all of the patients demonstrated response measured by the physician global assessment and were steroid free at 1 year. There were 8 infusion reactions. There were no malignancies, serious infections, or deaths.

Conclusions: IFX demonstrated a modest response rate and a low steroid-sparing effect in patients with IBD 7 years old and younger. Although this is a limited study, there appears to be a trend for decreased sustained efficacy with IFX in this age group, particularly in children 5 years old and younger, when compared with the previously published literature in older children.

IBD Update January 2015 (Part 2)

1. A retrospective study (Inflamm Bowel Dis 2014; 20: 2292-98) of 217 patients with inflammatory bowel disease(108 infliximab-treated, 109 adalimumab-treated) provides data which indicates that combination therapy (mainly with thiopurines) resulted in higher trough levels and lower antibodies to infliximab (ATI) than monotherapy in patients treated with infliximab (IFX).  This was not evident in the adalimumab (ADA)-treated patients. Overall, approximately 90% of study population had Crohn’s disease.

Key points from this study:

  • The majority of trough level/antidrug antibody levels were drawn due to loss of response.  This is a major limitation of this study.
  • Among IFX-treated patients, those with combination therapy had trough level of 7.5 mcg/mL compared with 4.6 mcg/mL.  In combination therapy patients, the incidence of ATIs was 5.7% compared with 29.8% in monotherapy patients.
  • According to this study, the dose of the immunomodulator (IM) did not significantly influence the infliximab trough level or antibody formation; that is, more than half of patients were receiving “suboptimal dosed IM” and their infliximab levels/ATIs were similar to those who were optimally-dosed.
  • Among those who were receiving combination therapy, the incidence of antibody formation was lower in IFX-treated patients who started IM concurrently with IFX compared with those in which IM was added subsequently.
  • There were many other limitations in this study, including the finding that 94% of monotherapy patients had received previous immunomodulator therapy.

Bottomline: This study suggests that combination therapy is beneficial for patients receiving infliximab (in agreement with the previous SONIC study) and may not be beneficial for patients receiving adalimumab; however, only a well-designed prospective study

2. Inflamm Bowel Dis 2014; 20: 2266-70.  This study with 749 patients from Sweden showed that a large number of inflammatory bowel disease patients did not receive with iron supplementation: “Only 46% of patients with anemia were treated with iron supplementation or blood transfusion.”  This study showed frequent persistence of anemia one year after diagnosis, especially in children. At time of diagnosis, 55% of children and 27% of adults had anemia and 28% and 16% at one year followup, respectively.

My take: Treatment of the underlying IBD, often helps anemia.  However, in some patients treating the anemia with iron may help improve symptoms as much or more than other aspects of treatment.

3. Inflamm Bowel Dis 2014; 20: 2433-49.  Reviews pain management approaches for patients with IBD. The article emphasizes how pain can be multifactoral and that opiod-induced hyperalgesia may worsen pain.

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Bryce Canyon

Bryce Canyon

 

IBD Update January 2015 (Part 1)

1. From the recent Advances in IBD Conference, Healio Gastroenterology reports on Dr. Baldassano’s update on PLEASE study which examined enteral nutrition in comparison to anti-TNF therapy.  Here’s the link: Enteral Nutrition Outcomes (Thanks to Kipp Ellsworth for this reference)

Here’s an excerpt:

Citing the findings from the Pediatric Longitudinal Study of Semi-Elemental Diet and Stool Microbiome (PLEASE), Baldassano demonstrated that greater mucosal healing was achieved in CD patients on exclusive enteral nutrition compared with partial enteral nutrition therapy. In this prospective cohort study, 38 children received enteral therapy with defined formula diet and 52 controls received anti-TNF-alpha therapy. The enteral nutrition group was further stratified to evaluate mucosal healing on a more restrictive diet; one subgroup received 80% to 90% of total caloric needs from enteral therapy, of which 14% achieved induction of remission at 8 weeks, the other subgroup received 90% to 100% of total caloric needs from enteral therapy, of which 45% achieved remission, and 62% of controls achieved remission.

2. NEJM 2014; 371: 2418-27. This is a case report of a 9-year-old with Crohn’s Disease and pulmonary nodules.  This report serves as a useful review.

3. Standardized use of fecal calprotectin (here’s the link -from KT Park’s Twitter feed):

Fecal calprotectin -use for identifying IBD and for identifying relapse risk

4. Inflamm Bowel Dis 2014; 20: 2247-59. Study examined factors associated with infliximab clearance.  Higher clearance noted with low albumin, high body weight, and the presence of antibodies to infliximab (ATI).  The authors note that higher concentrations with dose escalation are more likely when the dose interval was shortened than by increasing the administered dose.

5. Inflamm Bowel Dis 2014; 20: 2260-65. “Natural History of Perianal Crohn’s Disease After Fecal Diversion.”  Despite greater use of biologics, only 15 of 49 patients reestablished intestinal continuity between 2000-2011.  In this group of 15, only 5 remained reconnected and 3 of these 5 patients had procedures to control sepsis.  The likelihood of sustained intestinal continuity remains low in patients who have required a diverting procedure.

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Sandy Springs, Georgia

Sandy Springs, Georgia

IBD Incidence Increasing: 30 Years of Data from Manitoba

A recent study (JPGN 2014; 59: 763-66) shows a steady trend of increased incidence of IBD in Manitoba. This figure is available online:

 

Increasing IBD Incidence in Children

Increasing IBD Incidence in Children from JPGNonline

Abstract:

Objectives: The aim of this study was to describe the incidence and prevalence of inflammatory bowel disease (IBD) in children <17 years of age in 30 years from 1978 to 2007.

Methods: From January 1, 1978, to December 31, 2007, the sex- and age-adjusted annual incidence and prevalence of pediatric IBD per 100,000 population were calculated based on the pediatric IBD database of the only pediatric tertiary center in the province. The annual health statistics records for the Province of Manitoba were used to calculate population estimates for the participants. To ensure validity of data, the University of Manitoba IBD Epidemiology Database was analyzed for patients <17 years of age from 1989 to 2000.

Results: The sex- and age-adjusted incidence of pediatric Crohn disease has increased from 1.2/100,000 in 1978 to 4.68/100,000 in 2007 (P < 0.001). For ulcerative colitis, the incidence has increased from 0.47/100,000 in 1978 to 1.64/100,000 in 2007 (P < 0.001). During the same time period, the prevalence of Crohn disease has increased from 3.1 to 18.9/100,000 (P < 0.001) and from 0.7 to 12.7/100,000 for ulcerative colitis (P < 0.001). During the last 5 years of the study the average annual incidence of IBD in urban patients was 8.69/100,000 as compared with 4.75/100,000 for rural patients (P < 0.001).

Conclusions: The incidence and prevalence of pediatric IBD are increasing. The majority of patients were residents of urban Manitoba, confirming the important role of environmental factors in the etiopathogenesis of IBD.

Unrelated: As a bonus for those who made it to the bottom of this post : there’s a new Bristol Stool App for iPhones.  Here’s the link: http://www.bristol-stool-scale.com (from John Pohl’s twitter feed)

 

Enthusiasm for Vedolizumab

A recent GI & Hepatology News article quoted several leading IBD researchers stating that they consider Vedolizumab a first-line biologic therapy for ulcerative colitis.  Here’s the link:

Vedolizumab for UC

Here’s an excerpt:

Dr. Feagan presented outcome results after 80 and 104 weeks of vedolizumab treatment of 278 patients with ulcerative colitis who had completed a full year of treatment during the GEMINI 1 trial [Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis] (N. Engl. J. Med. 2013;369:699-710). He reported that the percentage of patients in clinical remission grew from 66% after 52 weeks on treatment (the time of entry into the long-term phase of the study), to 77% after 80 weeks, which then dropped to 73% after 104 weeks. Patients with a clinical response increased from 78% after 52 weeks to 88% after 80 weeks, and then dropped to 83% after 104 weeks.

During weeks 53-104 on treatment the rates of adverse events, serious adverse events, serious infections, adverse events resulting in treatment discontinuation, enteric infections, and malignancies were all low and similar to the event rates seen among the patients randomized to placebo in the GEMINI 1 study.

The results suggest that with vedolizumab treatment of inflammatory bowel disease “once you achieve an effect it is long-lasting,” Dr. Rutgeerts said in an interview. But he cautioned that the long-lasting efficacy was achieved with treatment every 4 weeks. While this approach was safe, it would also be expensive in routine practice, he noted. “The safety looks good, but the cost would be very high.”

“A key concept of vedolizumab is that it builds efficacy over time,” commented Dr. Silvio Danese during a talk at the meeting. “Vedolizumab is not the fastest runner, but [treating inflammatory bowel disease] is a marathon, and the important thing is getting to the finish”

Bottomline: Head-to-head trials would be helpful to determine which biologic agent should be considered first-line.

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