Note from the National Guideline Clearinghouse: See the original guideline document for discussions of the evidence and rationale supporting each recommendation statement.
Quality of evidence (High, Moderate, Low, Very low) and strength of recommendation (Strong and Weak) definitions are provided at the end of the "Major Recommendations" field.
Esophageal Stents in Malignant Disease
Malignant Strictures and Fistulas
Self-expanding metal stents (SEMSs) are superior to rigid plastic prostheses in the management of unresectable obstructive esophageal cancers. The quality of evidence for this recommendation is good and the strength of recommendations is strong.
Types of Stents
Self-expanding Metal Stents
Partially Covered versus Uncovered Stents
Partially covered SEMSs are superior to uncovered SEMSs in the palliation of malignant dysphagia because of unresectable obstructive esophageal cancers. The quality of evidence for this recommendation is good and the strength of recommendations is strong.
Comparison between Various SEMSs
Minor differences in efficacy and complication rates exist between the available SEMSs, and on the basis of the published data, the use of one brand of SEMSs over the other cannot be recommended. The quality of evidence for this recommendation is moderate and the strength of recommendation is strong.
Self-expanding Plastic Stents (SEPSs)
The use of SEMSs is associated with significantly fewer complications than SEPSs when inserted for malignant dysphagia. The quality of evidence for this recommendation is moderate and the strength of recommendation is strong.
Location of Malignancy
Given the conflicting results, the routine use of SEMSs with anti-reflux valve in the management of malignant dysphagia due to distal esophageal and gastric cardia malignancy for reducing gastroesophageal reflux cannot be recommended. The quality of evidence is low and the strength of recommendation is weak.
The use of SEMSs in proximal malignancy, in contrast, should be considered contingent upon proximity to the upper esophageal sphincter and tolerance. The quality of the evidence is moderate and the strength of recommendations is strong.
The endoscopic placement of covered SEMSs is the treatment of choice for malignant esophageal fistulas. The quality of the evidence for malignant fistula closure with SEMSs is moderate and the strength of the recommendation is strong (given the paucity of alternatives).
Application of SEMSs with Chemotherapy and/or Irradiation for Palliation of Malignant Dysphagia
On the basis of limited data, SEMSs in conjunction with chemo-irradiation cannot be routinely recommended. The quality of evidence for the use of SEMSs in this scenario is low and the strength of the recommendation is weak.
Comparison of SEMSs with Other Treatment Modalities
The use of brachytherapy as the primary modality for management of malignant dysphagia due to inoperable esophageal cancer cannot be recommended. The quality of evidence for use of brachytherapy for this indication is moderate and the strength of recommendation is weak.
Multiple complications caused by stent placement in esophageal malignancies have been described and range from 30% to 50% in most series. They are contingent upon tumor location, the presence or absence of a fistula or tumor shelf, use of concomitant chemoirradiation, tumor vascularity, and the diameter and design of the prosthesis itself. The quality of the evidence that increased stent diameter was associated with increased complications is moderate and the strength of evidence is high. The quality of evidence and the strength of evidence that other stricture characteristics are associated with higher complications are moderate and recommendation for SEMS placement is, nevertheless, high.
Esophageal Stents in Benign Disease
The ideal stent characteristics for effective management of benign esophageal lesions are as follows: the stent should be easily retrievable or repositioned, technically easy to place, designed to have a small-caliber delivery device with minimal shortening on usage, have low migration rates, and finally, insertion and removal should be associated with minimal complications.
SEMSs in Benign Esophageal Strictures
On the basis of prohibitive rate of complications, partially covered SEMSs in their current form are not recommended or US Food and Drug Administration (FDA) approved for benign esophageal conditions. The quality of evidence for the use of SEMSs for benign esophageal strictures is very low and the strength of recommendation is strong.
Complications of SEPSs in Benign Indications
On the basis of available results and lack of success, SEPSs cannot be routinely recommended in treating refractory benign esophageal strictures until there is significant improvement in the design. The quality of evidence for the use of SEPSs is very low and the strength of recommendation is weak.
Retrievable Self-expandable Metallic and Biodegradable Stents in Benign Esophageal Strictures
Further long-term prospective data obtained from controlled trials are awaited before retrievable self-expandable metallic and biodegradable stents can be recommended for the management of benign esophageal lesions.
Esophageal Stents in the Management of Esophageal Perforations, Leaks, and Fistulas
In selected cases, SEMSs and SEPSs can be considered in the treatment of esophageal perforation. However, the quality of evidence for the use of esophageal stenting in the management of esophageal perforations, leaks and fistulas is very low and the strength of recommendation is weak.
Esophageal stenting using SEMSs is currently the most common means of palliation of malignant dysphagia. SEMSs are clearly superior to rigid plastic prostheses in the management of unresectable obstructive esophageal cancers, and covered SEMSs are preferred to uncovered SEMSs mainly because of lower rates of tumor ingrowth. There are minor differences in the efficacy and complication rates between the various available SEMSs, and hence one brand of SEMSs over the other cannot be recommended. It seems that SEPSs when used for malignant dysphagia are associated with significantly higher complication rate than SEMSs. Future research should focus on the development of stents associated with low migration rates and less tumoral/nontumoral overgrowth that ultimately decrease reintervention rates.
Quality of Evidence — Definitions and Determinants
||Further research is very unlikely to change the confidence in the estimate of effect
Underlying methodology: randomized controlled trials
||Further research is likely to have an important impact on the confidence in the estimate of effect and may change the estimate
Underlying methodology: downgraded randomized controlled trials or upgraded observational studies
||Further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate
Underlying methodology: well-done observational studies with control groups
||Any estimate of effect is very uncertain
Underlying methodology: case reports or case series
Strength of Recommendation Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Classification and Implications for Patients, Clinicians, and Policy Makers
For patients: Most individuals in this situation would want the recommended course of action and only a small proportion would not. Formal decision aids are not likely to be required to help individuals make decisions consistent with their values and preferences.
For clinicians: Most individuals should receive the intervention. Adherence to this recommendation according to the guidelines could be used as a quality criterion or performance indicator.
For policy makers: The recommendation can be adapted as policy in most situations.
For patients: The majority of individuals in this situation would want the suggested course of action, but many would not. Decision aids may be useful in helping individuals make decisions consistent with their values and preferences.
For clinicians: Examine the evidence or a summary of the evidence yourself.
For policy makers: Policy making will require substantial debates and involvement of many stakeholders.