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

Summary

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.

Conditions

• Esophageal Achalasia
• Esophageal Motility Disorders

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Wei Gong, Doctor · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• China

Study Locations