Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia

May 11, 2017 updated by: Wei Gong, Nanfang Hospital of Southern Medical University

Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial

This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Silin Huang, Master
  • Phone Number: 86-13512756686
  • Email: 13816757@qq.com

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Gong, Doctor
        • Sub-Investigator:
          • Silin Huang, Master
        • Sub-Investigator:
          • Liyun Huang, Master
        • Sub-Investigator:
          • Hui Yue, Doctor
        • Sub-Investigator:
          • Jianuan Wu, Doctor
        • Sub-Investigator:
          • Xiaobing Cui, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between 18 and 75 years of age;
  2. Patient with esophageal achalasia;
  3. Eckardt score > 3;
  4. Signed informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: short-myotomy
Short-POEM for patients with esophageal achalasia
Procedure: short-myotomy
  1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 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 carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
  4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
  5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
ACTIVE_COMPARATOR: long-myotomy
Long-POEM for patients with esophageal achalasia
Procedure: long-myotomy
  1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 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 carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
  4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
  5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
EXPERIMENTAL: full-thickness myotomy
Full-thickness-POEM for patients with esophageal achalasia
Procedure: full-thickness myotomy
  1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 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 carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
  4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
  5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
ACTIVE_COMPARATOR: circular myotomy
Circular-POEM for patients with esophageal achalasia
Procedure: circular myotomy
  1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 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 carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
  4. Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact.
  5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic success
Time Frame: From date of randomization until the follow-up ended, assessed up to 5 years
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.)
From date of randomization until the follow-up ended, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure related complication
Time Frame: From date of randomization until the follow-up ended, assessed up to 5 years
Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc.
From date of randomization until the follow-up ended, assessed up to 5 years
Time of treatment failure
Time Frame: From date of randomization until the follow-up ended, assessed up to 5 years
Time of treatment failure is defined as when the Eckardt score of patients are more than 3.
From date of randomization until the follow-up ended, assessed up to 5 years
Pressure at the lower esophageal sphincter
Time Frame: From date of randomization until the follow-up ended, assessed up to 5 years
From date of randomization until the follow-up ended, assessed up to 5 years
From date of randomization until the follow-up ended, assessed up to 5 years
Quality of life
Time Frame: From date of randomization until the follow-up ended, assessed up to 5 years
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.
From date of randomization until the follow-up ended, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Wei Gong, Doctor, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2016-186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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