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
  Purpose

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.


Condition Intervention Phase
Achalasia
Procedure: Endoscopic esophageal myotomy
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: Endoscopic esophageal myotomy
Endoscopic esophageal myotomy
Procedure: Endoscopic esophageal myotomy
endoscopic esophageal myotomy (surgery)
Other Name: TEEM

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  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: NCT01402518

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, M.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, M.D. UCSD
  More Information

No publications provided

Responsible Party: Santiago Horgan, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT01402518     History of Changes
Other Study ID Numbers: 091170
Study First Received: July 21, 2011
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
achalasia
myotomy
endoscopic myotomy
difficulty swallowing

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014