Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

NCT03738566 | Completed Results FDA Device

• 1 other identifier: 18-000246
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Dilation; Refractory Benign Esophageal Stricture

Outcome Measures

Primary Outcomes (1)

• 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

  6 months following serial dilation

Secondary Outcomes (4)

• Length of Days Intervention Free

  6 months

• Mayo Dysphagia Questionnaire (MDQ-30) at Baseline

  Baseline

• Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months

  12 months

• Clinically Significant Adverse Events

  12 months

Study Arms (4)

Standard Clinical Care Endoscopic Dilation Group

ACTIVE COMPARATOR

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.

Procedure: Endoscopic therapy with esophageal dilation

Esophageal Self-Dilation Therapy (ESDT) Group

ACTIVE COMPARATOR

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.

Device: Esophageal self-dilation therapy

Observational Study Group

OTHER

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

Device: Esophageal self-dilation therapy; Procedure: Endoscopic therapy with esophageal dilation

Standard Clinical Care Endoscopic Dilation, Then ESDT

EXPERIMENTAL

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.

Device: Esophageal self-dilation therapy; Procedure: Endoscopic therapy with esophageal dilation

Interventions

Esophageal self-dilation therapy DEVICE

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.

Also known as: ESDT

Esophageal Self-Dilation Therapy (ESDT) Group; Observational Study Group; Standard Clinical Care Endoscopic Dilation, Then ESDT

Endoscopic therapy with esophageal dilation PROCEDURE

A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.

Observational Study Group; Standard Clinical Care Endoscopic Dilation Group; Standard Clinical Care Endoscopic Dilation, Then ESDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (20)

• 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.

  PMID: 10381932 BACKGROUND

• 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.

  PMID: 25019695 BACKGROUND

• 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.

  PMID: 22008891 BACKGROUND

• 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.

  PMID: 16111985 BACKGROUND

• 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.

  PMID: 16377340 BACKGROUND

• 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.

  PMID: 16279894 BACKGROUND

• 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.

  PMID: 19491851 BACKGROUND

• 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.

  PMID: 20236257 BACKGROUND

• 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.

  PMID: 21034894 BACKGROUND

• 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.

  PMID: 26542391 BACKGROUND

• 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.

  PMID: 26828759 BACKGROUND

• 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.

  PMID: 23925823 BACKGROUND

• 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.

  PMID: 23387392 BACKGROUND

• 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.

  PMID: 24950654 BACKGROUND

• 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.

  PMID: 20927061 BACKGROUND

• 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.

  PMID: 21221805 BACKGROUND

• 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.

  PMID: 20191010 BACKGROUND

• 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.

  PMID: 20927157 BACKGROUND

• 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.

  PMID: 11676328 BACKGROUND

• Halland M, Prichard DO, Kahn A, Lavey CJ, Katzka DA, Alexander JA. Esophageal Self-Dilation in Benign Refractory Esophageal Strictures: Outcomes from a Randomized Controlled Trial and a Prospective Observational Study. Dig Dis Sci. 2024 Aug;69(8):2883-2889. doi: 10.1007/s10620-024-08402-z. Epub 2024 May 29.

  PMID: 38811502 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Jeffrey A. Alexander
• Organization: Mayo Clinic

Alexander.Jeffrey14@mayo.edu

507-538-0474

Study Officials

• Jeffrey Alexander, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: November 21, 2018
• Primary Completion: July 2, 2021
• Study Completion: May 15, 2022
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)