Endoscopic Esophageal Myotomy for the Treatment of Achalasia (TEEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402518
First received: July 21, 2011
Last updated: July 25, 2011
Last verified: July 2011

July 21, 2011
July 25, 2011
November 2009
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01402518 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endoscopic Esophageal Myotomy for the Treatment of Achalasia
Endoscopic Esophageal Myotomy for the Treatment of Achalasia

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Achalasia
Procedure: Endoscopic esophageal myotomy
endoscopic esophageal myotomy (surgery)
Other Name: TEEM
Experimental: Endoscopic esophageal myotomy
Endoscopic esophageal myotomy
Intervention: Procedure: Endoscopic esophageal myotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
October 2013
October 2013   (final data collection date for primary outcome measure)
  • Subjects will be between the ages of 18-65 and have a diagnosis of achalasia (diagnosed by EGD and manometry). Following diagnosis, the investigator will ensure the patient meets study criteria. If the patient satisfies the listed criteria then Dr. Horgan will present study information and offer participation.
  • Patients between the ages of 18-65 who present in the UC San Diego Minimally Invasive Surgery clinic with the diagnosis of achalasia will be offered participation in this study. Patients must meet the following criteria:

Inclusion:

  • Diagnosis of achalasia
  • Age 18-65
  • ASA class 1-2

Exclusion:

  • Pregnant women
  • Any prior surgical treatment for achalasia
  • Patients who are taking immunosuppressive medications or are immunocompromised
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests
  • Patients with severe medical comorbidities will be excluded
Both
18 Years to 65 Years
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 619-471-0447 misresearch@ucsd.edu
United States
 
NCT01402518
091170
Yes
Santiago Horgan, M.D., University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, M.D. UCSD
University of California, San Diego
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP