ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01200147
Recruitment Status : Unknown
Verified September 2010 by Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2010
Last Update Posted : September 13, 2010
Sponsor:
Information provided by:
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Dysphagia Schatzki Ring Procedure: Biopsy Procedure: Dilation Not Applicable

Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

MedlinePlus related topics: Biopsy Tears
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Biopsy Arm Procedure: Biopsy
Active Comparator: Dilation Arm Procedure: Dilation



Primary Outcome Measures :
  1. Effectiveness of biopsy vs dilation


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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 Posted: September 13, 2010    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Rupture
Wounds and Injuries