POEM vs. Pneumatic Dilation for Esophageal Achalasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01768091
First received: January 5, 2013
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.


Condition Intervention
Esophageal Achalasia
Procedure: POEM
Procedure: Pneumatic dilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Therapeutic success [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]

    Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less.

    The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of <5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of >10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.)



Secondary Outcome Measures:
  • Procedure related complication [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]
    Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.

  • Time of treatment failure [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]
    Time of treatment failure is defined as when the Eckardt score of patients are more than 3

  • Pressure at the lower esophageal sphincter [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: No ]
    The basal LES pressure and the swallow-induced LES relaxation will be monitored and measured at the end of expiration. After introduction and equilibration, basal pressure is monitored during at least 5 minutes. Swallow-induced relaxation of the sphincter is assessed by 5 ml wet swallows, at least 30 s apart.

  • Quality of life [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]
    Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POEM
POEM for patients with esophageal achalasia
Procedure: POEM
  1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 13 cm proximal to the gastroesophageal junction (GEJ).
  2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
  3. Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm.
  4. Long endoscopic myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact. The expected end point of myotomy is 2 cm distal to the GEJ.
  5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.

(Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271)

Other Name: Peroral endoscopic myotomy
Active Comparator: Pneumatic dilation
Pneumatic dilation for patients with esophageal achalasia
Procedure: Pneumatic dilation

A Rigiflex balloon (30 mm) was positioned at the esophagogastric junction and dilated at a pressure of 5 PSI for 1 minute, followed by 8 PSI for 1 minute.

(N Engl J Med 2011;364:1807-16.)


Detailed Description:

Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.

Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.

Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

However, the long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 75 years of age
  • Patient with esophageal achalasia
  • Eckardt score > 3
  • Signed informed consent

Exclusion Criteria:

  • Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
  • Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus
  • Previous endoscopic Botox injection
  • Previous oesophageal or gastric surgery
  • Pregnancy or lactation women, or ready to pregnant women
  • Not capable of filling out questionnaires
  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: NCT01768091

Contacts
Contact: Wei Gong, M.D. +86 15820290385 gwei203@yahoo.com.cn

Locations
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Xiaobing Cui, M.D.    +86 13631312723    xbing119@gmail.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: Wei Gong, M.D. Department of Gastroenterology, Nanfang Hospital of Southern Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01768091     History of Changes
Other Study ID Numbers: NFEC-201211-K2, 201120
Study First Received: January 5, 2013
Last Updated: January 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
Esophageal achalasia
Peroral endoscopic myotomy
POEM
Pneumatic dilation

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

ClinicalTrials.gov processed this record on October 19, 2014