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

November 4, 2022 updated by: Nova Scotia Health Authority
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.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

None available, study was withdrawn

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • VG Hospital-Capital District Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Study withdrawn no details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark McMillan, MD FRCPC, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schatzki-2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

study withdrawn, no patients enrolled

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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