This is the current release of the guideline.

Gastrointestinal and mediastinal mass lesions

Diagnosis
Evaluation

Gastroenterology

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

To establish quality indicators to aid in the recognition of high-quality endoscopic ultrasonography (EUS) examinations

Patients undergoing endoscopic ultrasonography

Endoscopic ultrasonography

Safety and efficacy of procedure

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Studies were identified through a computerized search of Medline followed by review of the bibliographies of relevant articles. When such data were absent, indicators were chosen by expert consensus.

Not stated

Expert Consensus (Committee)

Not applicable

Systematic Review

Not stated

Expert Consensus

The American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG), as leaders in promoting the highest quality patient care, formed a task force to identify end points that could be used to document high-quality endoscopic services. In most cases these end points will require validation before they can be generally adopted. The task force consisted of expert endoscopists selected by the board of directors of the ASGE and the ACG.

The task force developed quality indicators for the 4 major endoscopic procedures: colonoscopy, esophagogastroduodenoscopy (EGD), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasonography (EUS). Wherever possible, these indicators were chosen because there were published supporting data. These studies were identified through a computerized search of Medline followed by review of the bibliographies of relevant articles. When such data were absent, indicators were chosen by expert consensus. The goal was to create a comprehensive list of potential quality indicators, recognizing that only a small subset may ultimately be implemented. The resultant quality indicators were graded on the strength of the supporting evidence.

Grades of Recommendation

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

The task force consisted of expert endoscopists selected by the board of directors of the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG). These documents were then reviewed and approved by the governing boards.

Recommendations were graded on the strength of the supporting evidence (Grades 1A - 3). Definitions of the recommendation grades are presented at the end of the "Major Recommendations" field.

Preprocedure Quality Indicators

1. Proper indication. Endoscopic ultrasonography (EUS) should be performed for an acceptable indication as defined by the American Society for Gastrointestinal Endoscopy (ASGE). Acceptable indications have been published previously (ASGE, 2000). (3)

   Discussion. Although there are many instances in which EUS can be performed, the necessity of the procedure in the care of any particular patient depends on its impact on management and the superiority of EUS over other available imaging or surgical procedures. This implies a certain degree of clinical judgment in choosing if and when to perform EUS in relation to other procedures, making rigid indications inadvisable. That being said, expert opinion has identified specific clinical situations for which EUS is deemed an appropriate diagnostic or therapeutic procedure (Table below). It is fully expected that certain indications may change with time. In addition, the appropriate use of EUS also depends in part upon the availability of other imaging methods because not all patients will have reasonable access to alternatives to EUS.

   It is also recognized that there may be unforeseen circumstances in which EUS can provide clinically useful information. For this reason, 100% compliance with predetermined indications is considered restrictive. However, the inclusion of an indication in the procedure documentation for all cases is considered a useful quality measure for 2 reasons. First, it provides a justification for the procedure and serves as a means of tracking compliance with accepted indications. In addition, the indication places the remainder of the procedure report in a specific context wherein certain endosonographic landmarks and finding characteristics should logically follow. For example, detailed descriptions of the pancreas may not be necessary when the indication for EUS is esophageal cancer staging. However, once esophageal cancer staging is provided as the indication, certain components of the examination, such as T and N staging, including celiac axis visualization barring nontraversibility, are expected and their subsequent inclusion would reflect a thorough EUS.

Table: Acceptable Indications for EUS According to the ASGE

2. Proper consent. Consent should be obtained and documented for every procedure. In addition to the risks associated with all endoscopic procedures, the consent should address the relevant and substantial complications pertaining to each specific EUS procedure. (3)

   Discussion. EUS and EUS-fine-needle aspiration (FNA) present some unique complication risks beyond those associated with standard endoscopy. A review of the complications specific to EUS have been published previously. In some instances, EUS requires passage of large echoendoscopes or endoscopes with relatively rigid portions. This has been associated with an increased risk of perforation. Perforation risk may also be higher when staging esophageal cancer, particularly in the setting of pre-EUS dilation of an obstructing malignancy. FNA introduces an increased risk of infection and hemorrhage, as well as pancreatitis when FNA of a pancreatic lesion is performed. Finally, a risk of tumor seeding along the FNA tract has been reported in very rare circumstances. Celiac plexus neurolysis or celiac plexus block (CPN or CPB) carry unique risks of hypotension and diarrhea, in addition to the standard risks.

3. Prophylactic antibiotics. Antibiotics should be administered in the setting of fine-needle aspiration (FNA) of cystic lesions. (2C)

   Discussion. There have been no randomized trials conducted to determine the need for prophylactic antibiotics in the setting of EUS-FNA of cystic lesions. One study examining the efficacy of EUS-FNA found no clinically significant bacteremia resulting from FNA of solid lesions. However, a subgroup analysis of patients with cysts undergoing FNA demonstrated a 14% risk of infectious complications.  There have also been reports of mediastinitis complicating FNA and tru-cut needle biopsy of bronchogenic cysts. This has led to the American Society for Gastrointestinal Endoscopy recommendation that prophylactic antibiotics be administered to all patients undergoing EUS-FNA of pancreatic cystic lesions.

Intraprocedure

4. Visualization of structures of interest. There should be documentation of the appearance of relevant structures, specific to the indication for the EUS. Specific quality indicators identified are as follows: (3)
   1. In the setting of esophageal cancer staging without obstruction, celiac axis visualization should be documented.
   2. In the setting of evaluating for the presence of pancreatic disease, visualization of the entire pancreas should be documented.

   Discussion. To maximize clinical efficacy, EUS should provide all pertinent information relevant to the procedure's indication. The endosonographer must visualize specific structures depending on the disease process being investigated and must subsequently document these findings in writing or with photo documentation.

5. Description of abnormalities. (3)
   1. All gastrointestinal cancers are staged with the American Joint Commission for Cancer (AJCC)/Union Internationale Contre le Cancre (UICC) TNM staging system. (AJCC, 2002; Sobin & Wittekind, 2002)
   2. Pancreatic mass measurements are documented.
   3. The EUS wall layers involved by subepithelial masses are documented.

   Discussion. A diagnosis based on EUS findings, with or without cytologic examination from FNA, requires not only an accurate localization and description of sonographic findings, but also an accurate interpretation of these findings within the individual patient's clinical context. Currently the AJCC/UICC TNM systems are the most widely used methods for staging gastrointestinal malignancies. Therefore, to maximize the utility of EUS in the setting of cancer staging, the elements necessary to assign both T and N stages should be obtained during the procedure and documented in writing and with saved images. This includes measurements of pancreatic masses because T staging may depend on tumor size.

   In the setting of subepithelial lesions, the differential diagnosis is based on wall layer of origin, echo characteristics, and size of lesion. Therefore, these findings should be documented in every report.

6. Appropriate use of biopsy. EUS-guided FNA is performed of celiac axis lymph nodes discovered at EUS staging of thoracic esophageal cancer. (2C)

   Discussion. The additional clinical information obtained from FNA can increase the diagnostic accuracy of EUS significantly by confirming a pathologic diagnosis, obtaining more accurate nodal staging in malignancy, and yielding fluid for various analyses, including chemical analyses, tumor markers, and bacterial/fungal stains or culture. It is also recognized that FNA is not feasible or appropriate in all conditions. For example, it is acknowledged that FNA through a tumor to obtain tissue from an adjacent lymph node may yield a false-positive result. It therefore becomes impossible to suggest a fixed percentage of EUS cases in which FNA should be done. However, when FNA is appropriate, the endosonographer should make every effort to incorporate this step into the EUS.

   In the setting of esophageal cancer in the thoracic esophagus, malignant celiac axis lymph nodes confer M1a status and alter patient management. It has also been shown that echo characteristics alone are not sufficiently accurate in predicting metastatic involvement of lymph nodes. The involvement of an on-site cytopathologist during EUS-FNA may help limit the number of FNA passes taken or increase the overall diagnostic accuracy of the procedure. However, it is recognized that not all endosonographers will have access to this degree of service. Therefore, in situations where a cytopathologist or cytotechnologist is not available, several FNA passes should be made to maximize sensitivity. For lymph nodes, prospective studies have suggested that 3 to 5 passes are adequate to maximize sensitivity.

Postprocedure

7. Complication rates. The incidence of pancreatitis after EUS-FNA of the pancreas is measured. (1C)

   Discussion. Patients undergoing EUS-FNA of the pancreas are at risk for development of pancreatitis, likely as a result of direct tissue injury as the needle traverses pancreatic tissue. The incidence of pancreatitis in this setting, including data from prospective series, has ranged between 0% and 2%.

Definitions:

Grades of Recommendation

*Adapted from Guyatt G, Sinclair J, Cook D, Jaeschke R, Schunemann H, Pauker S. Moving from evidence to action: grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, eds. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.

None provided

The type of supporting evidence is identified for each recommendation.

A high quality endoscopy ensures that the patient receives an indicated procedure, that correct and clinically relevant diagnoses are made (or excluded), that therapy is properly performed, and that all these are accomplished with minimal risk.

Endoscopic ultrasonography (EUS) and EUS-fine-needle aspiration (FNA) present some unique complication risks beyond those associated with standard endoscopy. In some instances, EUS requires passage of large echoendoscopes or endoscopes with relatively rigid portions. This has been associated with an increased risk of perforation. Perforation risk may also be higher when staging esophageal cancer, particularly in the setting of pre-EUS dilation of an obstructing malignancy. FNA introduces an increased risk of infection and hemorrhage, as well as pancreatitis when FNA of a pancreatic lesion is performed. Finally, a risk of tumor seeding along the FNA tract has been reported in very rare circumstances. Celiac plexus neurolysis or celiac plexus block (CPN or CPB) carry unique risks of hypotension and diarrhea, in addition to the standard risks.

• Underlying this discussion of quality indicators is the assumption that adequate training and credentialing has taken place before a practitioner begins the practice of endoscopy. The American Society for Gastrointestinal Endoscopy (ASGE) has guidelines specifically addressing standards for training, assessing competence, and granting privileges to perform endoscopy. It is the task force's recommendation that these guidelines be adopted by facilities where endoscopic procedures are performed.
• The list of potential quality indicators was meant to be a comprehensive listing of measurable endpoints. It is not the intention of the task force that all end points be measured in every practice setting. In most cases, validation may be required before a given end point may be universally adopted.

An implementation strategy was not provided.

Getting Better

Effectiveness
Patient-centeredness
Safety

Not applicable: The guideline was not adapted from another source.

2006 Apr

American College of Gastroenterology - Medical Specialty Society
American Society for Gastrointestinal Endoscopy - Medical Specialty Society

American Society for Gastrointestinal Endoscopy

American Society for Gastrointestinal Endoscopy/American College of Gastroenterology (ASGE/ACG) Taskforce on Quality in Endoscopy

Taskforce Members: Brian C. Jacobson, MD, MPH; Amitabh Chak, MD; Brenda Hoffman, MD; Todd H. Baron, MD; Jonathan Cohen, MD; Stephen E. Deal, MD; Klaus Mergener, MD, PhD; Bret T. Petersen, MD; John L. Petrini, MD; Michael A. Safdi, MD; Douglas O. Faigel, MD (ASGE Co-Chair) Irving M. Pike, MD (ACG Co-Chair)

Not stated

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI on September 15, 2006.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.