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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200147
First Posted: September 13, 2010
Last Update Posted: September 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nova Scotia Health Authority
  Purpose
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.

Condition Intervention
Dysphagia Schatzki Ring Procedure: Biopsy Procedure: Dilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • Effectiveness of biopsy vs dilation

Arms Assigned Interventions
Active Comparator: Biopsy Arm Procedure: Biopsy
Active Comparator: Dilation Arm Procedure: Dilation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200147


Contacts
Contact: Michael Curley, MD, FRCPC 9024043511 ma_curley@hotmail.com

Locations
Canada, Nova Scotia
VG Hospital-Capital District Health Authority Not yet recruiting
Halifax, Nova Scotia, Canada, B3H2Y9
Contact: Michael Curley, MD, FRCPC    9024043511    ma_curley@hotmail.com   
Contact: Mark MacMillan, MD, FRCPC    9024732222    mamacmil@dal.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
  More Information

Responsible Party: Dr. Michael Curley, Division of Gastroenterology, Department of Medicine
ClinicalTrials.gov Identifier: NCT01200147     History of Changes
Other Study ID Numbers: Schatzki-2010
First Submitted: September 10, 2010
First Posted: September 13, 2010
Last Update Posted: September 13, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Rupture
Wounds and Injuries