search
Back to results

Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Primary Purpose

Esophageal Dilation, Refractory Benign Esophageal Stricture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal self-dilation therapy
Endoscopic therapy with esophageal dilation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Dilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • 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
  • In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
  • 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Other

Experimental

Arm Label

Standard Clinical Care Endoscopic Dilation Group

Esophageal Self-Dilation Therapy (ESDT) Group

Observational Study Group

Standard Clinical Care Endoscopic Dilation, Then ESDT

Arm Description

Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.

Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform 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.

Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.

Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.

Outcomes

Primary Outcome Measures

Number of Endoscopic Interventions
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care

Secondary Outcome Measures

Length of Days Intervention Free
Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Clinically Significant Adverse Events
Number of clinically significant adverse events including perforation, bleeding and pain

Full Information

First Posted
November 6, 2018
Last Updated
May 22, 2023
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03738566
Brief Title
Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Official Title
Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Dilation, Refractory Benign Esophageal Stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects who agreed to participate in the randomized trial were randomized to standard clinical care consisting of endoscopic dilation as needed versus esophageal self-dilation therapy in a 1:1 ratio using a block randomization approach. Subjects randomized to the standard clinical care group were offered cross-over to the esophageal self-dilation therapy if they failed stand of care. Subjects who agreed to take part in in the observational prospective study either commenced ESDT or continued standard clinical care based on shared decision making with their esophageal provider.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Clinical Care Endoscopic Dilation Group
Arm Type
Active Comparator
Arm Description
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Arm Title
Esophageal Self-Dilation Therapy (ESDT) Group
Arm Type
Active Comparator
Arm Description
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform 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.
Arm Title
Observational Study Group
Arm Type
Other
Arm Description
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Arm Title
Standard Clinical Care Endoscopic Dilation, Then ESDT
Arm Type
Experimental
Arm Description
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Intervention Type
Device
Intervention Name(s)
Esophageal self-dilation therapy
Other Intervention Name(s)
ESDT
Intervention Description
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 therapy twice a day for at least one week.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy with esophageal dilation
Intervention Description
A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
Primary Outcome Measure Information:
Title
Number of Endoscopic Interventions
Description
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
Time Frame
6 months following serial dilation
Secondary Outcome Measure Information:
Title
Length of Days Intervention Free
Description
Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
Time Frame
6 months
Title
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
Description
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Time Frame
Baseline
Title
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
Description
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Time Frame
12 months
Title
Clinically Significant Adverse Events
Description
Number of clinically significant adverse events including perforation, bleeding and pain
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Alexander, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10381932
Citation
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. doi: 10.1016/s0016-5085(99)70572-x.
Results Reference
background
PubMed Identifier
25019695
Citation
Mendelson AH, Small AJ, Agarwalla A, Scott FI, Kochman ML. Esophageal anastomotic strictures: outcomes of endoscopic dilation, risk of recurrence and refractory stenosis, and effect of foreign body removal. Clin Gastroenterol Hepatol. 2015 Feb;13(2):263-271.e1. doi: 10.1016/j.cgh.2014.07.010. Epub 2014 Jul 11.
Results Reference
background
PubMed Identifier
22008891
Citation
de Wijkerslooth LR, Vleggaar FP, Siersema PD. Endoscopic management of difficult or recurrent esophageal strictures. Am J Gastroenterol. 2011 Dec;106(12):2080-91; quiz 2092. doi: 10.1038/ajg.2011.348. Epub 2011 Oct 18.
Results Reference
background
PubMed Identifier
16111985
Citation
Kochman ML, McClave SA, Boyce HW. The refractory and the recurrent esophageal stricture: a definition. Gastrointest Endosc. 2005 Sep;62(3):474-5. doi: 10.1016/j.gie.2005.04.050. No abstract available.
Results Reference
background
PubMed Identifier
16377340
Citation
Hordijk ML, Siersema PD, Tilanus HW, Kuipers EJ. Electrocautery therapy for refractory anastomotic strictures of the esophagus. Gastrointest Endosc. 2006 Jan;63(1):157-63. doi: 10.1016/j.gie.2005.06.016.
Results Reference
background
PubMed Identifier
16279894
Citation
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. doi: 10.1111/j.1572-0241.2005.00331.x.
Results Reference
background
PubMed Identifier
19491851
Citation
Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.
Results Reference
background
PubMed Identifier
20236257
Citation
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.
Results Reference
background
PubMed Identifier
21034894
Citation
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.
Results Reference
background
PubMed Identifier
26542391
Citation
Nijhawan S, Udawat HP, Nagar P. Aggressive bougie dilatation and intralesional steroids is effective in refractory benign esophageal strictures secondary to corrosive ingestion. Dis Esophagus. 2016 Nov;29(8):1027-1031. doi: 10.1111/dote.12438. Epub 2015 Nov 6.
Results Reference
background
PubMed Identifier
26828759
Citation
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.
Results Reference
background
PubMed Identifier
23925823
Citation
Dzeletovic I, Fleischer DE, Crowell MD, Pannala R, Harris LA, Ramirez FC, Burdick GE, Rentz LA, Spratley RV Jr, Helling SD, Alexander JA. Self-dilation as a treatment for resistant, benign esophageal strictures. Dig Dis Sci. 2013 Nov;58(11):3218-23. doi: 10.1007/s10620-013-2822-7. Epub 2013 Aug 8.
Results Reference
background
PubMed Identifier
23387392
Citation
Zehetner J, DeMeester SR, Ayazi S, Demeester TR. Home self-dilatation for esophageal strictures. Dis Esophagus. 2014 Jan;27(1):1-4. doi: 10.1111/dote.12030. Epub 2013 Feb 6.
Results Reference
background
PubMed Identifier
24950654
Citation
Kachaamy T, Lott D, Crujido LR, Rentz L, Fleischer D. Esophageal luminal restoration for a patient with a long lye-induced stricture via tunnel endoscopic therapy during a rendezvous procedure followed by self-dilation (with video). Gastrointest Endosc. 2014 Jul;80(1):192-4. doi: 10.1016/j.gie.2014.02.026. No abstract available.
Results Reference
background
PubMed Identifier
20927061
Citation
Dzeletovic I, Fleischer DE. Self-dilation for resistant, benign esophageal strictures. Am J Gastroenterol. 2010 Oct;105(10):2142-3. doi: 10.1038/ajg.2010.212. No abstract available.
Results Reference
background
PubMed Identifier
21221805
Citation
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.
Results Reference
background
PubMed Identifier
20191010
Citation
Lee HJ, Lee JH, Seo JM, Lee SK, Choe YH. A single center experience of self-bougienage on stricture recurrence after surgery for corrosive esophageal strictures in children. Yonsei Med J. 2010 Mar;51(2):202-5. doi: 10.3349/ymj.2010.51.2.202. Epub 2010 Feb 12.
Results Reference
background
PubMed Identifier
20927157
Citation
Wong KK, Hendel D. Self-dilation for refractory oesophageal strictures: an Auckland City Hospital study. N Z Med J. 2010 Aug 27;123(1321):49-53.
Results Reference
background
PubMed Identifier
11676328
Citation
Bapat RD, Bakhshi GD, Kantharia CV, Shirodkar SS, Iyer AP, Ranka S. Self-bougienage: long-term relief of corrosive esophageal strictures. Indian J Gastroenterol. 2001 Sep-Oct;20(5):180-2.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

We'll reach out to this number within 24 hrs