The Committee recognized that endoscopy is a service and not a disease (or a related group of diseases). This dictated that a wide, panoramic “lens” be employed to view all the possible avenues of endoscopic research.
The endoscope is a vital tool for the pediatric gastroenterologist. Endoscopic studies enable visualization of the mucosa of the upper and lower gastrointestinal (GI) tracts. Tissue sampling and fluid collections broaden the diagnostic capability of the pediatric endoscopist. Endoscopy also provides an opportunity to perform therapeutic procedures.
Upper GI tract endoscopy, with appropriate tissue sampling and fluid collections, can establish the diagnoses of esophagitis, Barrett's esophagus, gastroesophageal varices, hiatal hernia, focal and diffuse gastritis (e.g., H pylori-related gastritis), gastric outlet obstruction, duodenal ulcer disease, duodenitis (acid-mediated, infectious or nonspecific) and diffuse enteropathies (e.g., celiac disease). Colonoscopy allows for the diagnoses of infectious and nonspecific inflammatory processes of the distal ileum and colon. Obstructing lesions, vascular malformations and intraluminal masses can be identified at the time of colonoscopy. Endoscopic retrograde cholangiopancreatography (ERCP) provides a means of identifying obstructing and inflammatory processes in the hepatobiliary and pancreatic ducts of infants and children. Diagnostic ERCP also identifies congenital abnormalities and sites of duct disruption or leakage after injury from trauma or surgery.
Therapeutic endoscopy enables dilation of esophageal strictures, ligation of bleeding esophageal varices, percutaneous placement of feeding gastrostomy tubes, direct control of intragastric and duodenal bleeding lesions, insertion of nasojejunal or gastrojejunal feeding tubes, removal of upper and lower GI polypoid masses, ablation of upper and lower GI tract vascular malformations, placement of percutaneous cecostomy buttons (for antegrade colonic enemas) and dilation of colonic strictures. ERCP enables dilation of biliary tract and pancreatic duct strictures, with or without stenting; removal of common bile duct or pancreatic duct stones; sphincterotomy; pseudocyst drainage; and stenting to divert biliary leaks.
AREAS OF EMPHASIS
Develop a North American Pediatric Endoscopic Database System
Many endoscopic practices in pediatric gastroenterology are modeled after adult patterns. This is recognized as being suboptimal. Currently, there are no available data on pediatric endoscopic activities at a national level. There are no outcome data regarding the medical effectiveness or cost-effectiveness of endoscopic intervention in pediatric patients.
Seed money is expected for a pilot study of pediatric endoscopic outcomes data, referred to as PEDS-CORI (P ediatric E ndoscopy D atabase S ystem—C linical O utcomes R esearch I nitiative). This system will provide not only a simple and accurate endoscopy report but also a comprehensive, computerized database for research inquiries. Recently, information from the CORI database, which is virtually identical to the PEDS-CORI template, was published in a review of patterns of adult endoscopic use in the US (1). A pediatric endoscopic database can be an important resource for future ongoing research in endoscopy by documenting current practice patterns and changes over time.
For a data bank to be effective, however, we must establish uniformity in the conduct of procedures, interpretation of endoscopic findings, interpretation of histologic data, and correlation of endoscopic and histologic findings. For example, Hetzel's classification of mucosal findings of esophagitis (2), commonly used in both adult and pediatric management effectiveness studies, does not truly fit the findings in pediatric patients and thereby illustrates the need for relevant pediatric endoscopic data. A system like PEDS-CORI would generate photographic images, included in the report, which allow objective review of the mucosal findings and provide reproducible research results. Establishment of a data bank of this type will also have a positive impact on endoscopy education. The PEDS-CORI project will serve as a template for national collaborative research in pediatric GI diseases.
Projected Timetable and Funding Requirements
The projected time frame is 3 years. Funding requirements are estimated at $150,000 per year. Ongoing funding for the PEDS-CORI project is already in place.
Critically Examine Indications, Findings and Outcomes of Endoscopic Procedures
Studies would critically examine the indications, findings and outcomes of procedures, and then assess a final value for each procedure. The data generated could be employed in health economic modeling to determine whether the cost of endoscopy is positively balanced by the establishment of a precise diagnosis. Such data are also useful in the development of evidence-based management strategies. This study should also enable generation of accurate data on the relevant cost of doing business.
Longitudinal multicenter collaborative studies are appropriate. Multicenter protocols for the endoscopic assessment of common pediatric conditions would encompass endoscopic findings, results of pre-set histologic studies, assessment of professional and patient satisfaction, and total costs.
Multicenter studies are also recommended to compare the use of conscious sedation versus general anesthesia. Protocols would include a) predesigned objectives for each clinical indication and b) clinical outcomes, whether assessed by the study group or by patients. A study comparing total costs would permit identification of clinical scenarios in which conscious sedation is equally effective with general anesthesia and those in which general anesthesia is preferred.
Projected Timetable and Funding Requirements
The projected time frame is 3 years.
Develop Tools for Endoscopy Training and Education
There is a need for efforts in three areas: assessment of Fellows, continuing medical education (CME) and the testing of clinical endoscopic competency. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)-wide instruments are needed to assess trainees after each endoscopic procedure in order to document improvement over time and eventual competency (3–5). Consideration should be given to the concept of “areas of excellence” for advanced training. This “research in education” project should be accomplished in pediatric endoscopic units, although some training may have to be done in adult endoscopic units.
Consideration should also be given to the development of tools for the testing of pediatric clinical endoscopic competency. This might eventually lead to certification (and possibly recertification) of pediatric clinical endoscopic competency.
Through the Children's Digestive Health and Nutrition Foundation (CDHNF), NASPGHAN can create CME-accredited training programs (e.g., videos, CD-ROM and workshops) for pediatric endoscopists (6,7). An effort must be made to bring about uniformity in pediatric endoscopic expertise.
Projected Timetable and Funding Requirements
The projected time frame is 5 years.
Apply Newer Technologies in Pediatric Endoscopy
Increased clinical experience with the following technologies would yield additional information and facilitate medical decision-making:
Endoscopic ultrasonography (EUS) is rarely performed in pediatric patients, yet it would allow further investigation of subepithelial lesions and lesions in areas adjacent to the upper and lower GI tracts. EUS combines the diagnostic imaging capability of ultrasonography with the access afforded by endoscopy. Composite instrumentation permits the placement of a piezoelectric transducer directly adjacent to the target tissue, thereby obviating the need to transmit sound waves through media that attenuate sound, such as air in the lungs, gas in the bowel or bone, as is the case with standard transcutaneous ultrasonography (8) This technology also enables biopsy of these lesions. EUS can delineate the dimensions of pancreatic pseudocysts and afford an opportunity to drain these lesions. EUS is currently underused in pediatrics.
ERCP permits anatomic investigation of the biliary and pancreatic ductal systems. Other capabilities include aspiration of bile and pancreatic fluid for culture, biopsy of the biliary mucosa and cholangioscopy (9,10). Ultrathin ERCP scopes allow investigation of the biliary tree in infants with neonatal cholestasis (11). In patients with postprandial epigastric pain, ERCP with manometric measurements of the pancreatic or biliary sphincter can reveal high sphincter pressures, which can be reduced by sphincterotomy (9).
Endoscopic spectroscopy is a means of evaluating the colonic mucosa for early neoplasia in patients with longstanding inflammatory bowel disease. It can also facilitate identification of flat adenomatous lesions in patients with adenomatous polyposis coli. Further evolution of this tool might one day allow macroscopic identification of different types of inflammatory infiltrates (e.g., eosinophilic versus neutrophilic versus lymphocytic).
The primary indication for enteroscopy in children is the identification of small-intestinal bleeding and obstructing lesions. This is currently accomplished by collaboration with pediatric surgery and combined laparotomy/enteroscopy (12). It is conceivable, however, that newer equipment will have wider application for the evaluation of small-bowel lesions that are distal to the ligament of Treitz and proximal to the distal ileum (13). The new technology of capsule endoscopy should be explored for use in children.
Biodegradable stents for children. Self-expanding metallic stents are now available that can be compressed into a narrow device and placed with minimal or no prior esophageal dilation (14). These stents are used to palliate intrinsic and extrinsic obstructive lesions in the esophagus. In the future, expandable stents may be constructed of biodegradable materials. Biodegradable stents could be used in the management of infants and children with stenotic lesions in the esophagus (e.g., post-tracheoesophageal fistula repair, caustic injuries and peptic strictures) to reduce the number of repeat dilations.
In addition to the technologies described above, there is a need to continue the search for a child-friendly, safe and cost-effective bowel preparation regimen that permits thorough colonoscopy in all pediatric patients (15,16). Possible future technologies include robot-controlled capsule endoscopy and high-magnification endoscopy for better evaluation of mucosal detail.
Projected Timetable and Funding Requirements
The projected time frame is 5 years (but ongoing).
HEALTH AND ECONOMIC OUTCOMES
Currently there are no data to properly assess the economic impact of pediatric endoscopy on direct health care costs. Properly designed studies will clarify the impact of endoscopic procedures on the overall care of infants and children with GI dysfunction.
The studies outlined above will establish an evidence base for the appropriate use of endoscopy in the management of infants and children with GI tract pathology. Moreover, these studies will promote the standardization of endoscopic interventions in children and facilitate multicenter collaborative research programs.
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