to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

NCT01742494

Esophageal Achalasia

UNKNOWN NA

Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

NCT01873300

Achalasia

COMPLETED PHASE1/PHASE2

Development of Endoscopic Treatment for Achalasia

NCT04180241

Achalasia

ACTIVE_NOT_RECRUITING NA

Comparative Study of Per-oral Endoscopic Myotomy (POEM) in Treatment - naïve Achalasia Patients Versus Patients With Previous Pneumatic Dilation

NCT07287787

Achalasia, Esophageal

NOT_YET_RECRUITING NA

Quality of Life After POEM for Achalasia

NCT05010889

Esophageal Achalasia

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Achalasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

POEM preserving longitudinal muscle

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

Group Type EXPERIMENTAL

POEM preserving longitudinal muscle

Intervention Type PROCEDURE

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

POEM involving longitudinal muscle

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

Group Type ACTIVE_COMPARATOR

POEM involving longitudinal muscle

Intervention Type PROCEDURE

participants are operated POEM involving both circular and longitudinal muscle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POEM preserving longitudinal muscle

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

Intervention Type PROCEDURE

POEM involving longitudinal muscle

participants are operated POEM involving both circular and longitudinal muscle

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes