Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Study Details
Study Description
Brief Summary
Among patients with refractory benign esophageal stricture (RBES) who were treated endoscopically, we hypothesized the following:
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Compared to a endoscopy as needed approach, esophageal self -dilation therapy (ESDT) decreases the number of endoscopic dilation, prolong dysphagia free interval
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Esophageal self -dilation therapy is safe and well tolerated therapy
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ESDT significantly lower the health cost in managing refractory esophageal stricture
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous dilations. Although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations.
Patients with RBES are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy, and/ or temporary stent placement. These procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician.
Esophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Endoscopic Dilation Patients randomized to the observation group will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses. A relapse will be considered if a patient developed solid food dysphagia at least once a week. |
Procedure: Upper Endoscopy with Dilation
Patients will undergo repeat endoscopy and dilation as needed if their dysphagia relapse which is the current standard of care.
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Active Comparator: Esophageal Self Dilation Patients will be instructed to start Esophageal self dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months. |
Device: Esophageal self dilation
Esophageal self dilation therapy (ESDT), where the patient learns to pass a polyvinyl dilator orally on a routine basis teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months as directed by the esophageal care team.
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Outcome Measures
Primary Outcome Measures
- The tolerability of esophageal self dilation compared to observation defined as number of endoscopic interventions [6 months]
The number of patients who remained free of endoscopic therapy between the two groups
Secondary Outcome Measures
- Esophagram [6 months]
The esophagram is an x-ray test that assesses the diameter of the esophagus. Patients whose esophagus achieves and remains 10-12mm
- Mayo Dysphagia Questionnaire 30 Day (MDQ-30) [1 year]
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. A total score of 40 or higher indicates positive for dysphagia, and a total score of 15 or lower is considered negative for dysphagia. Scores between 15 and 40 are considered indeterminate for dysphagia.
- Upper endoscopy: Number of endoscopic interventions [6 months]
Participants who experience dysphagia more than once per week will return for an upper endoscopy and dilation
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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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:
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Patient with malignant esophageal stricture
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Angulated stricture which prevents safe passage of Maloney dilator in office setting
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In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
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Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
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The presence of esophageal stent
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Inability to learn self-dilation secondary to blindness or cognitive dysfunction
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Use of chronic anticoagulants
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Jeffrey Alexander, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
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- Dzeletovic I, Fleischer DE, Crowell MD, Kim HJ, Harris LA, Burdick GE, McLaughlin RR, Spratley RV Jr, Sharma VK. Self dilation as a treatment for resistant benign esophageal strictures: outcome, technique, and quality of life assessment. Dig Dis Sci. 2011 Feb;56(2):435-40. doi: 10.1007/s10620-010-1503-z. Epub 2011 Jan 8.
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- Ramage JI Jr, Rumalla A, Baron TH, Pochron NL, Zinsmeister AR, Murray JA, Norton ID, Diehl N, Romero Y. A prospective, randomized, double-blind, placebo-controlled trial of endoscopic steroid injection therapy for recalcitrant esophageal peptic strictures. Am J Gastroenterol. 2005 Nov;100(11):2419-25.
- Repici A, Hassan C, Sharma P, Conio M, Siersema P. Systematic review: the role of self-expanding plastic stents for benign oesophageal strictures. Aliment Pharmacol Ther. 2010 Jun;31(12):1268-75. doi: 10.1111/j.1365-2036.2010.04301.x. Epub 2010 Mar 17. Review.
- Repici A, Small AJ, Mendelson A, Jovani M, Correale L, Hassan C, Ridola L, Anderloni A, Ferrara EC, Kochman ML. Natural history and management of refractory benign esophageal strictures. Gastrointest Endosc. 2016 Aug;84(2):222-8. doi: 10.1016/j.gie.2016.01.053. Epub 2016 Jan 30.
- Repici A, Vleggaar FP, Hassan C, van Boeckel PG, Romeo F, Pagano N, Malesci A, Siersema PD. Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. Gastrointest Endosc. 2010 Nov;72(5):927-34. doi: 10.1016/j.gie.2010.07.031.
- Spechler SJ. American gastroenterological association medical position statement on treatment of patients with dysphagia caused by benign disorders of the distal esophagus. Gastroenterology. 1999 Jul;117(1):229-33.
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