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

NCT03012854 | Unknown DMC

• 1 other identifier: NFEC-2016-186
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Esophageal achalasia; Peroral endoscopic myotomy; POEM

Outcome Measures

Primary Outcomes (1)

• Therapeutic success

  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 Outcomes (4)

• Procedure related complication

  From date of randomization until the follow-up ended, assessed up to 5 years

• Time of treatment failure

  From date of randomization until the follow-up ended, assessed up to 5 years

• Pressure at the lower esophageal sphincter

  From date of randomization until the follow-up ended, assessed up to 5 years

• Quality of life

  From date of randomization until the follow-up ended, assessed up to 5 years

Study Arms (4)

short-myotomy

EXPERIMENTAL

Short-POEM for patients with esophageal achalasia

Procedure: short-myotomy

long-myotomy

ACTIVE COMPARATOR

Long-POEM for patients with esophageal achalasia

Procedure: long-myotomy

full-thickness myotomy

EXPERIMENTAL

Full-thickness-POEM for patients with esophageal achalasia

Procedure: full-thickness myotomy

circular myotomy

ACTIVE COMPARATOR

Circular-POEM for patients with esophageal achalasia

Procedure: circular myotomy

Interventions

short-myotomy 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.

short-myotomy

long-myotomy 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.

long-myotomy

full-thickness myotomy 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

circular myotomy 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.

circular myotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guanzhou, Guangdong, 510515, China

RECRUITING

Related Publications (2)

• Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.

  PMID: 20354937 BACKGROUND

• Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.

  PMID: 21561346 BACKGROUND

Related Links

• Homepage of Nanfang Hospital of Southern Medical University
• Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University

MeSH Terms

Conditions

Esophageal Achalasia; Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Wei Gong, Doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Gong, Doctor

CONTACT

86-15820290385; drgwei@foxmail.com

Silin Huang, Master

CONTACT

86-13512756686; 13816757@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine，Associate Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)