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Safety and Effectiveness of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Overview

About this study

The purpose of this study is to assess the clinical effectiveness of ESDT for patients with RBES defined as the number of endoscopic interventions  6 months following serial dilation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Therapy:

  • 18 years of age or older;
  • Patient who presents to the esophageal clinic with refractory benign esophageal strictures;
  • Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period;
  • Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week.

Exclusion Criteria:

  • Patient with malignant esophageal stricture;
  • Angulated stricture which prevents safe passage of Maloney dilator in office setting;
  • Known significant esophageal motor disorder (i.e., achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*;
  • The presence of esophageal stent;
  • Inability to learn self-dilation secondary to blindness or cognitive dysfunction;
  • Use of chronic anticoagulants.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Alexander, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Francisco Ramirez, M.D.

Closed for enrollment

More information

Publications

  • Endoscopic dilatation of corrosive esophageal strictures is effective, but some patients are refractory to it and require long-term repeated dilatations. The present study was carried out to analyze whether rigorous schedule of endoscopic bougie dilatation along with intralesional injection of triamcinolone in patients refractory to endoscopic dilatation alone could decrease the number and frequency of endoscopic dilatations. The inclusion criterion for this prospective study was patients with refractory corrosive esophageal stricture of any age group. Refractory benign esophageal stricture is defined as an anatomic fibrotic esophageal restriction with inability to achieve dilatation of ≥14 mm or to maintain dilatation for 4 weeks once ≥14 mm diameter is achieved. The patients were followed up prospectively for 1 year. Patients with refractory strictures were subjected to weekly bougie dilatation (Savary-Gilliard) of the strictures along with injections of intralesional triamcinolone (40 mg/mL, 1 mL diluted in 1 mL of saline, 0.5 mL injected per quadrant of stricture) for consecutive 5 weeks, referred to as rigorous schedule. Further dilatation was done on an 'on-demand' basis. Eleven patients were enrolled for the study. Dysphagia score improved from pre-intervention score of 3.54 ± 0.52 to 0.45 ± 0.52 post-intervention (P < 0.001). The maximum dilatation achieved pre-intervention was 9.90+1.04 mm Savary-Gilliard and post-intervention significantly improved to 14.7 + 0.7 mm Savary-Gilliard (P < 0.001). The periodic dilatation index defined as number of dilatations per month also significantly improved from pre-intervention score of 2.54 ± 1.06 to post-intervention score of 0.19 + 0.13 (P < 0.001). No adverse effects were reported by the patients. Rigorous weekly schedule of bougie dilatation and intralesional triamcinolone in combination is safe and effective in achieving significant dilatation, reducing the frequency dilatations, maintaining dilatation and improving dysphagia till 1 year of follow-up. Read More on PubMed
  • The natural history of refractory benign esophageal strictures (RBES) is unclear, and surgery or percutaneous endoscopic gastrostomy (PEG) may be the only viable long-term options. The aim of the present study was to assess the long-term outcomes of patients with RBES. Read More on PubMed
  • Esophageal anastomotic strictures often require repeat dilation to relieve dysphagia. Little is known about factors that affect their remediation. We investigated long-term success and rates of recurrence or refractoriness after dilation and factors associated with refractory stenosis. Read More on PubMed
  • Esophageal strictures secondary to caustic ingestion, head and neck radiation and at the anastomosis post-esophagectomy tend to be refractory to one or several dilatations. One option for these strictures is home self-dilatation. The aim of this study was to assess the efficacy and safety of home self-dilatation for a refractory esophageal stricture. A retrospective chart review was performed of all patients from 1997 to 2009 that performed home self-dilatation for an esophageal stricture. Patients with proximal strictures without tortuosity or a shelf proximal to the stricture were selected for self-dilatation. The patients were taught self-dilatation by the surgeon and an experienced nurse, and an appropriate sized Maloney dilator was provided to the patient and returned when no longer needed. There were 16 patients (11 male and 5 female) with a median age of 60 years (range 38-78). The stricture was related to the anastomosis after esophagectomy in 12 patients, caustic injury in 3 patients and cervical chemoradiotherapy in 1 patient. Prior to initiation of self-dilatation patients had a median of four endoscopic dilatations. Self-dilatation was done with a Maloney dilator ranging in size from 45 to 60 French. The median duration of self-dilatation was 16 weeks. No patient had a perforation or complication related to self-dilatation. No patient required stenting or repetitive endoscopic dilatations because of failure of self-dilatation. Strictures recurred in two patients after cessation of self-dilatation and both responded to endoscopic dilatation followed by additional self-dilatation. Self-dilatation effectively resolves refractory esophageal strictures. It was well tolerated, and there were no complications in this series. Home self-dilatation should be considered the treatment of choice in appropriate patients with refractory esophageal strictures in the cervical esophagus. Read More on PubMed
  • Simple benign strictures may be relieved with one to three dilation sessions. Resistant benign strictures are anatomically complex and resistant to therapy. We sought to determine the efficacy and safety of esophageal self-dilation with bougie dilators in the largest series to date. Read More on PubMed
  • Esophageal strictures are a common problem in gastroenterological practice. In general, the management of malignant or benign esophageal strictures is different and requires a different treatment approach. In daily clinical practice, stent placement is a commonly used modality for the palliation of incurable malignant strictures causing dysphagia, whereas, if available, intraluminal brachytherapy can be considered in patients with a good performance status. Recurrent dysphagia frequently occurs in malignant cases. In case of tissue in- or overgrowth, a second stent is placed. If stent migration occurs, the stent can be repositioned or a second (preferably partially covered) stent can be placed. Food obstruction of the stent lumen can be resolved by endoscopic cleansing. The cornerstone of the management of benign strictures is still dilation therapy (Savary-Gilliard bougie or balloon). There are a subgroup of strictures that are refractory or recur and an alternative approach is required. In order to prevent stricture recurrence, steroid injections into the stricture followed by dilation can be considered. In case of anastomotic strictures or Schatzki rings, incisional therapy is a safe method in experienced hands. Temporary stent placement is a third option before considering self-bougienage or surgery as a salvage treatment. In this review, the most frequently used endoscopic treatment modalities for malignant and benign stricture management will be discussed based on the available literature, and some practical information for the management in daily clinical practice will be provided. Read More on PubMed
  • Resistant benign esophageal strictures can have a negative impact on patients' quality of life. A portion of these patients require frequent physician performed dilations, leading to numerous interactions with their attendant inconvenience and sense of dependence. This study demonstrates the efficacy, safety and effect on quality of life of this under-utilized technique. Read More on PubMed
  • Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. Read More on PubMed
  • To determine the demographics, indications and long-term outcomes of patients using self-dilators for refractory oesophageal strictures. Read More on PubMed
  • Treatment of refractory or recurrent benign oesophageal strictures is demanding and surgery may be the only available option. The role of self-expanding plastic stents (SEPS) in the treatment of these strictures is still controversial because of the conflicting results of various studies. Read More on PubMed
  • This study was undertaken to evaluate the long-term treatment of esophageal strictures in children with corrosive esophagitis and to determine the effect of self-bougienage on recurrent strictures. Read More on PubMed
  • Internally fully covered self-expandable metal stents (FCSEMSs) have recently become available offering the possibility of removal. However, to our knowledge, the feasibility, techniques for endoscopic removal, and tissue reaction to FCSEMS have not been reported in humans. Our aims are (1) to report reasons for and success of FCSEMS removal in consecutive patients, (2) to describe methods of esophageal stent retrieval, and (3) to describe stent reactions induced by FCSEMS in humans. Read More on PubMed
  • Anastomotic esophageal stenoses after esophageal resection are common and sometimes are refractory to Savary bougie dilation. The efficacy of electrocautery needle-knife treatment in these patients is described. Read More on PubMed
  • The aim of the study was to examine whether endoscopic intralesional corticosteroid injection into recalcitrant peptic esophageal strictures reduces the need for repeat stricture dilation. Read More on PubMed
  • Corrosive esophageal strictures require dilatation at frequent intervals. Read More on PubMed
  • This document presents the official recommendations of the American Gastroenterological Association (AGA) on treatment of patients with dysphagia caused by benign disorders of the distal espophagus. It was approved by the Clinical Practice and Practice Economics Committee on September 27, 1998, and by the AGA Governing Board on November 8, 1998. Read More on PubMed

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