Development of Endoscopic Treatment for Achalasia

NCT ID: NCT04180241

Last Updated: 2024-05-08

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2027-12-31

Brief Summary

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

Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.

Detailed Description

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

Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.

Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).

At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.

Conditions

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

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

POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.

Study Groups

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

total division of the muscle layer

POEM- total division of the circular muscle layer into the gastroesophageal junction

Group Type ACTIVE_COMPARATOR

POEM

Intervention Type PROCEDURE

Peroral endoscopic myotomy

partial division of the muscle layer

POEM - partial division of the circular muscle layer into the gastroesophageal junction

Group Type ACTIVE_COMPARATOR

POEM

Intervention Type PROCEDURE

Peroral endoscopic myotomy

Interventions

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

POEM

Peroral endoscopic myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Newly diagnosed achalasia
* the patient should understand the nature and the purpose of the study and give informed consent

Exclusion Criteria

* previous surgical treatment of achalasia
* inability to understand the contents of or follow the protocol
* other pathology as an explanation for the obstruction of the esophageal transition
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anders Thorell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Thorell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, Sweden

Site Status

Karolinska Institutet

Stockholm, Stockholm County Council, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/1630-31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Per-Oral Endoscopic Myotomy
NCT01402518 COMPLETED