Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Achalasia
• Intervention / Treatment: Procedure: Water-jet POEM; Procedure: Conventional POEM

Detailed 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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping-Hong Zhou, M.D, PhD; Phone Number: 86-13681971063; Email: zhou1968@yahoo.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Water-jet POEM; POEM were performed by the use of Erbe Hybrid knife (WJ group)	Procedure: Water-jet POEM; Water-jet assisted POEM procedure was performed
Active Comparator: Conventional POEM; POEM were performed by the conventional technique using injection and triangle tip knife (C group).	Procedure: Conventional POEM; POEM were performed by the use of conventional technique using injection and triangle tip knife.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Procedure time in both groups	during POEM procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical efficacy and safety	bleeding complications, pneumothorax or pleural effusion requiring intervention	during hospital stay and up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Ping-Hong Zhou, M.D., PhD, Fudan University

Publications and helpful links

General Publications

• Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 2, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Esophageal Achalasia,; Peroral endoscopic myotomy,; Water-jet assisted
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: Hybrid POEM