NCT03733756

Brief Summary

Achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. Longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type Ⅱcases. Clinical observations also conclude that type Ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. Thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.

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
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

November 6, 2018

Last Update Submit

November 11, 2018

Conditions

Esophageal Achalasia

Outcome Measures

Primary Outcomes (1)

  • efficacy of POEM treatment

    Eckardt score ≤3; Eckardt scale includes 4 items: dysphagia, weight loss, poststernal pain and esophageal reflux, each item ranging from 0-3. The higher the score reaches, the more severe the disease is. It is considered to be efficient if the Eckardt score is ≤3 after POEM.

    4 weeks after POEM

Secondary Outcomes (1)

  • complications(GERD) of POEM treatment

    4 weeks after POEM

Study Arms (2)

POEM preserving longitudinal muscle

EXPERIMENTAL

participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact

Procedure: POEM preserving longitudinal muscle

POEM involving longitudinal muscle

ACTIVE COMPARATOR

participants are operated POEM involving the whole layer of muscle, both circular and longitudinal muscle

Procedure: POEM involving longitudinal muscle

Interventions

POEM preserving longitudinal musclePROCEDURE

participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact

POEM preserving longitudinal muscle
POEM involving longitudinal musclePROCEDURE

participants are operated POEM involving both circular and longitudinal muscle

POEM involving longitudinal muscle

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed of esophageal achalasia
  • Patients or legal surrogates willing and competent to give informed consent

You may not qualify if:

  • postoperative or post-POEM
  • post-pneumatic dilation or post-stenting
  • fail to go through high frequency intraluminal ultrasound （HFIUS)
  • Patients with American Society of Anesthesiologists （ASA） score ≥3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

  • Hong SJ, Bhargava V, Jiang Y, Denboer D, Mittal RK. A unique esophageal motor pattern that involves longitudinal muscles is responsible for emptying in achalasia esophagus. Gastroenterology. 2010 Jul;139(1):102-11. doi: 10.1053/j.gastro.2010.03.058. Epub 2010 Apr 8.

    PMID: 20381493BACKGROUND

  • Schoeman MN, Holloway RH. Secondary oesophageal peristalsis in patients with non-obstructive dysphagia. Gut. 1994 Nov;35(11):1523-8. doi: 10.1136/gut.35.11.1523.

    PMID: 7828966BACKGROUND

  • Liu ZQ, Li QL, Chen WF, Zhang XC, Wu QN, Cai MY, Qin WZ, Hu JW, Zhang YQ, Xu MD, Yao LQ, Zhou PH. The effect of prior treatment on clinical outcomes in patients with achalasia undergoing peroral endoscopic myotomy. Endoscopy. 2019 Apr;51(4):307-316. doi: 10.1055/a-0658-5783. Epub 2018 Sep 27.

    PMID: 30261536BACKGROUND

  • Mittal RK, Liu J, Puckett JL, Bhalla V, Bhargava V, Tipnis N, Kassab G. Sensory and motor function of the esophagus: lessons from ultrasound imaging. Gastroenterology. 2005 Feb;128(2):487-97. doi: 10.1053/j.gastro.2004.08.004.

    PMID: 15685559BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ping-Hong Zhou, MD,PhD

    Zhongshan Hospital, Fudan University, Shanghai, China

    STUDY CHAIR

Central Study Contacts

Quan-lin Li, MD

CONTACT

+86-021-64041990liquanlin321@126.com

Jia-qi Xu, MD

CONTACT

+86-1522190108515221901085@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

August 31, 2020

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

CN(1)