Endoscopic Esophageal Myotomy for the Treatment of Achalasia (TEEM)
Recruitment status was Recruiting
This is a pilot study for the endoscopic treatment of achalasia. Treatment involves undergoing a trans-esophageal endoscopic myotomy. The aims of the study are to assess the safety and efficacy of this novel endoscopic approach to the treatment of achalasia, and to assess the quality of life, pain, and complications associated with the endoscopic approach.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Esophageal Myotomy for the Treatment of Achalasia|
- Pain assessment based on the Visual Analog Scale. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Pain levels will be assessed using the Visual Analog Scale (VAS) at Baseline, 6 months, and 1 year.
- Dysphagia Assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Dysphagia will be assessed using the Dysphagia Assessment at baseline, 6 months, and 1 year.
- Reflux symptoms assessment using the GERD HRQL. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Reflux symptoms will be assessed using the GERD HRQL at baseline, 6 months, and 1 year.
- Quality of life assessment using the SF36. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Quality of Life will be assessed at baseline, 6 months, and 1 year.
- Safety assessment based on the # of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Endoscopic esophageal myotomy
Endoscopic esophageal myotomy
Procedure: Endoscopic esophageal myotomy
endoscopic esophageal myotomy (surgery)
Other Name: TEEM
This is a pilot study for the endoscopic treatment of achalasia. 10 patients will be recruited for this trial with a one-year follow-up.
All patients who come to the UC San Diego Minimally Invasive Surgery clinic with the diagnosis of achalasia will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.
Typical pre-operative diagnostic studies will be performed to evaluate the patient's anatomy and diagnosis of achalasia. This includes a barium swallow study, esophageal manometry, upper endoscopy, chest xray, and preoperative labs (CBC, CHEM 10, INR, PTT, PT). All patients will be evaluated by the anesthesia service. Once the diagnosis of achalasia has been confirmed, the patient will be enrolled in the study once all of the risks and benefits are thoroughly explained.
On the day of the procedure, the patient will be placed under general anesthesia in the operating room.
The patients will be kept NPO until a gastrograffin swallow study is performed on post-op day 1 to ensure there is not an esophageal leak. Once this is determined, the patient will be placed on a liquid diet.
Follow up will begin at one week in surgery clinic. At this appointment we will evaluate the patient's pain level, vital signs, and ability to swallow. At one month postoperative, if a stent was placed, the patient will undergo upper endoscopy and the esophageal stent will be removed. Once the stent is removed, the esophagus and incision will be inspected. If a stent was not placed the follow up at one month will occur over the telephone. At six months the patients will be seen in the surgery clinic, answer questionnaires and undergo a manometry. For the 12 month visit patients will be seen in the surgery clinic and asked to answer questionnaires. Further visits and/or treatments will be provided as necessary.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402518
|Contact: Sarah Lazar, MPHfirstname.lastname@example.org|
|Contact: Cece Echon, RN, MSNemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Principal Investigator: Santiago Horgan, M.D.|
|Principal Investigator:||Santiago Horgan, M.D.||UCSD|