NCT02454335

Brief Summary

Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

May 10, 2015

Last Update Submit

December 28, 2017

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

  • Change in Eckardt Score

    The standardized clinical scoring system for achalasia will be assessed at 2 weeks, 3 months, 6 months, and 1 year post procedure. The score is based on the results of a self- administered questionnaire using 4 items related to digestive symptoms including weight loss, dysphagia, retrosternal pain, and regurgitation. Each item is rated from 0 to 3 (0= none, 1= occasional, 2=daily, 3=with every meal).

    up to 24 months

Secondary Outcomes (11)

  • Rate of GERD by pH-impedance

    up to 24 months

  • Quality of Life by QoL S36 questionnaire

    up to 2 years

  • Dysphagia by the Dysphagia Score

    up to 24 months

  • Postoperative pain by VAS analogue scale

    2 years

  • Analgesic use by Analgesic Quantification Algorithm

    up to 24 months

  • +6 more secondary outcomes

Study Arms (2)

Anterior Approach

ACTIVE COMPARATOR

For the anterior approach, an incision will be made in the 1 to 2 o'clock position of the esophageal wall.

Procedure: Peroral Endoscopic Myotomy

Posterior Approach

ACTIVE COMPARATOR

For the posterior approach, a mucosal incision will be made at the 5 to 6 o'clock position

Procedure: Peroral Endoscopic Myotomy

Interventions

Peroral Endoscopic MyotomyPROCEDURE

The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.

Also known as: POEM
Anterior ApproachPosterior Approach

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient age greater than 18 years old
  • Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)

You may not qualify if:

  • Previous surgery of the esophagus or stomach
  • Active severe esophagitis
  • Large lower esophageal diverticula
  • Large \> 3cm hiatal hernia
  • Sigmoid esophagus
  • Known gastroesophageal malignancy
  • Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
  • Cirrhosis with portal hypertension, varices, and/or ascites
  • Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
  • Acute gastrointestinal bleeding
  • Uncorrectable coagulopathy defined by INR \> 1.5 or platelet \< 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Khashab MA, Sanaei O, Rivory J, Eleftheriadis N, Chiu PWY, Shiwaku H, Ogihara K, Ismail A, Abusamaan MS, El Zein MH, Wong VW, Billioux VG, Kumbhari V, Kalloo AN, Ponchon T, Pioche M. Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial. Gastrointest Endosc. 2020 Feb;91(2):288-297.e7. doi: 10.1016/j.gie.2019.07.034. Epub 2019 Aug 10.

    PMID: 31408652DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 27, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Locations

US(1)