NCT01570621

Brief Summary

Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

April 1, 2012

Last Update Submit

April 3, 2012

Conditions

AchalasiaPostoperative Complications

Keywords

achalasiaperoral endoscopic myotomyLES pressurepostoperative complicationsymptom reliefesophageal barium

Outcome Measures

Primary Outcomes (4)

  • symptom relief

    compare patients' symptoms before and after POEM at 1 month, 12 months.

    1-12months

  • Lower esophageal sphincter pressure

    compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.

    1-12months

  • improvement of esophageal barium

    compare esophageal barium before and after POEM at 1 months,12 months

    1-12 months

  • Postoperative complications

    postoperative complications

    0-12months

Interventions

peroral endoscopic myotomyPROCEDURE

A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
  • Age over 18 years old
  • Signed written informed consent

You may not qualify if:

  • Patients with previous surgery of the stomach or esophagus
  • With known coagulopathy
  • Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Hiatal hernia \> 2cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (2)

  • von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.

    PMID: 22068665BACKGROUND

  • 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: 20354937BACKGROUND

MeSH Terms

Conditions

Esophageal AchalasiaPostoperative Complications

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tingsheng Ling

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice-principal

Study Record Dates

First Submitted

April 1, 2012

First Posted

April 4, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

CN(1)