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Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation

Primary Purpose

Dysphagia, Schatzki Ring

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
study withdrawn no details
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring

Exclusion Criteria:

  • Prior esophageal or gastric surgery, severe esophagitis, coagulopathy

Sites / Locations

  • VG Hospital-Capital District Health Authority

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Study withdrawn no details

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2010
Last Updated
November 4, 2022
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01200147
Brief Title
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
Official Title
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Manufacturer stopped producing rings
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysphagia is a common reason for referal to the investigators Gastoenterology service. As many as 14% of patients undergoing radiological studies for dysphagia are found to have schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki rings are based on ancedotal experience and uncontrolled studies. The only randomized study on comparison of techniques the investigators were able to locate was published in 2000 and included only 26 patients. This study demonstrated that the biopsy techinque was as effective as and better tolerated than the standard dilation technique. Considering that the cost and time required for dilatation is greater than the basic biopsy technique, significant cost savings could be achieved using the biopsy technique. As well, patient satisfaction is an important factor considering that Schatzki rings can recur and repeated endoscopy is often required. Therefore, a study that shows a technique to be as or better than the current standard in effectiveness, cost, time, and patient comfort could lead to shift in current practice.
Detailed Description
None available, study was withdrawn

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Schatzki Ring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study withdrawn no details
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
study withdrawn no details

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring Exclusion Criteria: Prior esophageal or gastric surgery, severe esophagitis, coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark McMillan, MD FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
VG Hospital-Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
study withdrawn, no patients enrolled

Learn more about this trial

Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation

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