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Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Primary Purpose

Esophageal Achalasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Water-jet POEM
Conventional POEM
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Achalasia focused on measuring Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Water-jet POEM

Conventional POEM

Arm Description

POEM were performed by the use of Erbe Hybrid knife (WJ group)

POEM were performed by the conventional technique using injection and triangle tip knife (C group).

Outcomes

Primary Outcome Measures

Procedure time in both groups

Secondary Outcome Measures

clinical efficacy and safety
bleeding complications, pneumothorax or pleural effusion requiring intervention

Full Information

First Posted
November 20, 2012
Last Updated
December 2, 2012
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01742494
Brief Title
Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Official Title
Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
Keywords
Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water-jet POEM
Arm Type
Active Comparator
Arm Description
POEM were performed by the use of Erbe Hybrid knife (WJ group)
Arm Title
Conventional POEM
Arm Type
Active Comparator
Arm Description
POEM were performed by the conventional technique using injection and triangle tip knife (C group).
Intervention Type
Procedure
Intervention Name(s)
Water-jet POEM
Intervention Description
Water-jet assisted POEM procedure was performed
Intervention Type
Procedure
Intervention Name(s)
Conventional POEM
Intervention Description
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Primary Outcome Measure Information:
Title
Procedure time in both groups
Time Frame
during POEM procedure
Secondary Outcome Measure Information:
Title
clinical efficacy and safety
Description
bleeding complications, pneumothorax or pleural effusion requiring intervention
Time Frame
during hospital stay and up to 1 year
Other Pre-specified Outcome Measures:
Title
Therapeutic success
Description
a reduction in the Eckardt score to ≤3
Time Frame
Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Hong Zhou, M.D, PhD
Phone
86-13681971063
Email
zhou1968@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, M.D., PhD
Organizational Affiliation
Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24232052
Citation
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.
Results Reference
derived

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Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

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