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Guideline Summary
Guideline Title
Role of esophageal stents in benign and malignant diseases.
Bibliographic Source(s)
Sharma P, Kozarek R, Practice Parameters Committee of American College of Gastroenterology. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol. 2010 Feb;105(2):258-73; quiz 274. [116 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Benign and malignant diseases of the esophagus

  • Malignant esophageal obstruction with dysphagia
  • Extrinsic esophageal compression due to primary or secondary tumors
  • Refractory or recurrent esophageal strictures
  • Tracheoesophageal fistula
  • Esophageal perforation or leak
Guideline Category
Assessment of Therapeutic Effectiveness
Management
Technology Assessment
Clinical Specialty
Gastroenterology
Internal Medicine
Oncology
Surgery
Intended Users
Advanced Practice Nurses
Health Care Providers
Hospitals
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To provide an evidence-based approach to the role of esophageal stents in the management of benign and malignant diseases

Target Population

Adults with benign or malignant diseases of the esophagus undergoing stent placement

Interventions and Practices Considered

Esophageal stent placement

  • Self-expanding metal stents (SEMSs)
  • Self-expandable plastic stents (SEPSs)
Major Outcomes Considered
  • Technical success rate of stent placement
  • Survival rate
  • Dysphagia relief
  • Reintervention rate
  • Performance status
  • Complications
  • Cost-effectiveness

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The guidelines are based on a critical review of the available scientific literature on the topic identified in Medline and PubMed (January 1992 to December 2008) using search terms that included stents, self-expandable metal stents, self-expandable plastic stents, esophageal cancer, esophageal adenocarcinoma, esophageal squamous cell carcinoma, esophageal stricture, perforations, anastomotic leaks, tracheoesophageal fistula, and achalasia.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence — Definitions and Determinants

Grade Definition
High Further research is very unlikely to change the confidence in the estimate of effect

Underlying methodology: randomized controlled trials
Moderate 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
Low 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
Very low Any estimate of effect is very uncertain

Underlying methodology: case reports or case series
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

The quality of evidence and strength of recommendations have been assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, which is a system that has been adopted by multiple national and international societies. The GRADE system is based on a sequential assessment of quality of evidence, followed by assessment of the balance between benefits vs. downsides (harms, burden, and costs) and subsequent judgment regarding the strength of recommendation.

Methods Used to Formulate the Recommendations
Not stated
Description of Methods Used to Formulate the Recommendations

Not applicable

Rating Scheme for the Strength of the Recommendations

Strength of Recommendation Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Classification and Implications for Patients, Clinicians, and Policy Makers

Strong Recommendations

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.

Weak Recommendations

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.

Cost Analysis
  • Despite the initial higher costs of self-expanding metal stents (SEMSs) compared with conventional prosthesis, metal stents proved to be cost-effective because of decreased hospitalization stay and the absence of fatal complications.
  • There are no formal cost-effectiveness data, as the differences in cost among the available stent types are relatively small; this is unlikely to determine the type of stent to be used in the palliation of malignant dysphagia.
  • Although a formal cost-effectiveness analysis was not conducted, in one study, the median total charges, total direct costs, and insurance payments in the self-expandable plastic stents (SEPSs) plus dilation group were about twice the cost of dilation alone. If a single dilation was spared, the costs were equivalent, and if more than one dilation was spared, then SEPSs plus dilation was more cost efficient.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

These guidelines have been developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the Board of Trustees.

Recommendations

Major Recommendations

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.

Fistula Closure

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.

Complications

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.

Conclusions

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.

Definitions:

Quality of Evidence — Definitions and Determinants

Grade Definition
High Further research is very unlikely to change the confidence in the estimate of effect

Underlying methodology: randomized controlled trials
Moderate 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
Low 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
Very low 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

Strong Recommendations

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.

Weak Recommendations

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.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Improved knowledge of the role of esophageal stents in the management of benign and malignant diseases

Potential Harms

Complications caused by stent placement in esophageal malignancies include inadequate expansion with increased post-procedural dysphagia, variable throat or chest pain, prosthesis migration with or without subsequent bowel obstruction, esophageal erosions with bleeding or fistulization, and significant reflux when placed across the gastroesophageal junction (GEJ). Other complications include stent-related perforation and tumor ingrowth or overgrowth, as well as benign obstruction by elicitation of granulation tissue. Complications approximate 30% to 35% in most series and increase as the intensity and duration of follow-up increases.

See also Table 6, "Complications of Esophageal Self-expandable Metal Stents," and Table 7, "Clinical Series Evaluating Self-expandable Plastic Stents for benign Esophageal Diseases," in the original guideline document.

Qualifying Statements

Qualifying Statements

As with other practice guidelines, these guidelines are not intended to replace clinical judgment but rather to provide general guidelines applicable to the majority of patients. Clinicians need to integrate recommendations with their own clinical judgment, and with individual patient circumstances, values, and preferences. They are intended to be flexible, in contrast to standards of care, which are inflexible policies designed to be followed in every case.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
End of Life Care
Getting Better
Living with Illness
IOM Domain
Effectiveness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Sharma P, Kozarek R, Practice Parameters Committee of American College of Gastroenterology. Role of esophageal stents in benign and malignant diseases. Am J Gastroenterol. 2010 Feb;105(2):258-73; quiz 274. [116 references] PubMed External Web Site Policy
Adaptation

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

Date Released
2010 Feb
Guideline Developer(s)
American College of Gastroenterology - Medical Specialty Society
Source(s) of Funding

American College of Gastroenterology

Guideline Committee

Practice Parameters Committee

Composition of Group That Authored the Guideline

Authors: Prateek Sharma, MD; Richard Kozarek, MD

Practice Parameters Committee Members: John M. Inadomi, MD, FACG (Committee Chair); Darren S. Baroni, MD; David E. Bernstein, MD, FACG; William R. Brugge, MD, FACG; Lin Chang, MD; John T. Cunningham, MD, FACG; Kleanthis G. Dendrinos, MD; Steven A. Edmundowicz, MD; Philip M. Ginsburg, MD; Kelvin Hornbuckle, MD; Costas H. Kefalas, MD, FACG; Timothy R. Koch, MD, FACG; Jenifer K. Lehrer, MD; Anthony J. Lembo, MD; Tarun Mullick, MD; John J. O'Brien, MD; John P. Papp Sr, MD, MACG; Henry P. Parkman, MD, FACG; Kumaravel S. Perumalsamy, MD; Ganapathy A. Prasad, MD; Waqar A. Qureshi, MD, FACG; Albert C. Roach, PharmD, FACG; Richard E. Sampliner, MD, MACG; Amnon Sonnenberg, MD, MSc, FACG; John J. Vargo, II, MD, MPH, FACG; Santhi S. Vege, MD, FACG; Marcelo F. Vela, MD, FACG; Nizar N. Zein, MD; Marc J. Zuckerman, MD, FACG

Financial Disclosures/Conflicts of Interest

The authors declare no conflict of interest.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the American College of Gastroenterology (ACG) Web site External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on May 30, 2012.

Copyright Statement

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

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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