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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

POEM vs. Pneumatic Dilation for Esophageal Achalasia

NCT01768091

Esophageal Achalasia

UNKNOWN NA

Assessment of Different Modified POEM for Achalasia

NCT04578769

Esophageal Achalasia

RECRUITING NA

Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

NCT01742494

Esophageal Achalasia

UNKNOWN NA

POEM: Long vs Short Myotomy for Achalasia. RCT

NCT03450928

Achalasia

UNKNOWN NA

Comparative Study of Per-oral Endoscopic Myotomy (POEM) in Treatment - naïve Achalasia Patients Versus Patients With Previous Pneumatic Dilation

NCT07287787

Achalasia, Esophageal

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Achalasia Esophageal Motility Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

short-myotomy

Short-POEM for patients with esophageal achalasia

Group Type EXPERIMENTAL

short-myotomy

Intervention Type PROCEDURE

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.

long-myotomy

Long-POEM for patients with esophageal achalasia

Group Type ACTIVE_COMPARATOR

long-myotomy

Intervention Type PROCEDURE

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.

full-thickness myotomy

Full-thickness-POEM for patients with esophageal achalasia

Group Type EXPERIMENTAL

full-thickness myotomy

Intervention Type PROCEDURE

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.

circular myotomy

Circular-POEM for patients with esophageal achalasia

Group Type ACTIVE_COMPARATOR

circular myotomy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No