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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 because the information has not been verified recently.
Verified September 2010 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01200147
First received: September 10, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Effectiveness of biopsy vs dilation

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Dr. Michael Curley, Division of Gastroenterology, Department of Medicine
ClinicalTrials.gov Identifier: NCT01200147     History of Changes
Other Study ID Numbers: Schatzki-2010
Study First Received: September 10, 2010
Last Updated: September 10, 2010
Health Authority: Canada: Capital Heath Research Ethics Board

ClinicalTrials.gov processed this record on November 20, 2014