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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01793922
Other study ID # S55020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date January 2025

Study information

Verified date February 2023
Source KU Leuven
Contact Koen Bellens, MSc.
Phone 016 34 19 43
Email koen.bellens@kuleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Between 18 and 75 yr of age - Manometric diagnosis of achalasia - Eckardt score > 3 - Informed consent Exclusion Criteria: - Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk previous treatment, except treatment with nitroderivatives, Ca++ channel blockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm diameter or smaller. Pseudo-achalasia Mega-esophagus (> 7 cm) and/or sigmoid-like esophagus Previous esophageal or gastric surgery (except for gastric perforation) Not capable to fill out questionnaires (f.e. due to language barrier) Not available for follow-up Esophageal diverticula in the distal esophagus Malignant or premalignant esophageal lesions Patients with liver cirrhosis and/or esophageal varices Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PD
pneumodilation
POEM
peroral endoscopic myotomy

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary therapeutic succes The time till failure is the primary outcome parameter. The time is measured from date of pneumatic dilation (last session) or POEM to date of relapse of symptoms (date of establishment). Symptoms will be evaluated using the Eckardt scoring system (Table 1.). Therapeutic success is defined as a drop in Eckardt score to = 3 after treatment and symptom control at yearly follow-up which is also defined as an Eckardt score of = 3.
If symptoms recur within patients randomized for pneumatic dilation, retreatment with pneumatic dilation is allowed according to the protocol. If retreatment does not result in reduction of the symptom score below 4, the patient will be considered as a treatment failure.
2 years
Secondary quality of life The quality of life is determined using a general QoL questionnaire, namely the SF36 questionnaire. In addition, a more disease specific questionnaire, i.e. the EORTC QLQ-OES24 questionnaire, is filled out. These questionnaires have scored the QoL at fixed time points during follow-up (1 month, 3 months and yearly). 2 years
Secondary complication rate Complications (perforation, bleeding, etc) occurring during or immediately following the procedure are recorded by the attending phycisian.
In addition, gastroesophageal reflux is measured using 24h pHmetry after 3 months and 1 year. The number of patients with pathological acid exposure (>4.5% of time a pH<4) will be assessed. Endoscopy is performed after 1 year to detect esophagitis. Esophagitis rates and LA grades of esophagitis will be assessed.
2 years
Secondary need for retreetment Retreatment is allowed in the pneumodilation group when symptoms recur, which is defined as an Eckardt score of > 3. Symptom scores are assessed after one month, three months and then yearly. 2 years
See also
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