This is the current release of the guideline.

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

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

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

Esophageal stent placement

• Self-expanding metal stents (SEMSs)
• Self-expandable plastic stents (SEPSs)

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.

Not stated

Quality of Evidence — Definitions and Determinants

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.

Not applicable

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.

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.

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

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.

None provided

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

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

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.

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.

An implementation strategy was not provided.

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

American College of Gastroenterology

Practice Parameters Committee

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

The authors declare no conflict of interest.

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the American College of Gastroenterology (ACG) Web site .

None available

None available

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

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