Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of E... | NCT01525732

Studies
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders

NCT01525732

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

May 1, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Achalasia
Hypertensive LES

Interventions

Per Oral Endoscopic Myotomy

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Apr 25, 2017Actual

Completion Date

Apr 25, 2017Actual

First Submitted Date

Feb 1, 2012

First Submission Date that Met QC Criteria

Feb 2, 2012

First Posted Date

Feb 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2017

Last Update Posted Date

May 1, 2017Actual

Description Module

Brief Summary

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POEM	Other	Per Oral Endoscopic Myotomy	Procedure: Per Oral Endoscopic Myotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Per Oral Endoscopic Myotomy	Procedure		POEM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dysphagia score before and after P.O.E.M.		From 1st day after POEM to within 2 weeks after POEM

Secondary Outcomes

Measure	Description	Time Frame
Eckardt score before and after P.O.E.M.		Before and 1 month after POEM
Post-operative pain		From Day 1 to until 2 weeks after POEM
Operative time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

Patients will be excluded from this study with the followings -
1. Pregnancy
2. Informed consent not available
3. Previous history of esophagectomy or mediastinal surgery
4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese University of Hong Kong		Hong Kong			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23043852	Derived	Chiu PW, Wu JC, Teoh AY, Chan Y, Wong SK, Liu SY, Yung MY, Lam CC, Sung JJ, Chan FK, Lau JY, Ng EK. Peroral endoscopic myotomy for treatment of achalasia: from bench to bedside (with video). Gastrointest Endosc. 2013 Jan;77(1):29-38. doi: 10.1016/j.gie.2012.08.018. Epub 2012 Oct 6.

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases