Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Esophageal Achalasia Clinical Trial

Official title:

Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742494
• Other study ID #: Hybrid POEM
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2012
• Last updated: December 2, 2012
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Shanghai Zhongshan Hospital
• Contact: Ping-Hong Zhou, M.D, PhD
• Phone: 86-13681971063
• Email: zhou1968[@]yahoo.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Description:

Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• With an Eckardt symptom score = 4

• The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)

• Informed patient consent was obtained

Exclusion Criteria:

• Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk

• Pseudoachalasia

• Megaesophagus (diameter of > 7 cm)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Achalasia

Intervention

Procedure:
• Water-jet POEM
Water-jet assisted POEM procedure was performed
• Conventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.

Locations

Country	Name	City	State
China	Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapeutic success	a reduction in the Eckardt score to =3	Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year	Yes
Primary	Procedure time in both groups		during POEM procedure	Yes
Secondary	clinical efficacy and safety	bleeding complications, pneumothorax or pleural effusion requiring intervention	during hospital stay and up to 1 year	Yes