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Development of Endoscopic Treatment for Achalasia (POEM)

Primary Purpose

Achalasia

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
POEM
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Ersta Hospital
  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

total division of the muscle layer

partial division of the muscle layer

Arm Description

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

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

Outcomes

Primary Outcome Measures

The proportion of patients who develop gastroesophageal reflux disease (GERD)
Measured as esophageal acid exposure (pH <4) > 4% of recorded time

Secondary Outcome Measures

Esophageal emptying function
Measured by Time Barium Swallow X-ray
Eckardt score
The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome.
RAND-36
The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome.
Dysmotility
measured by Manometry
Gastrointestinal Symptom Rating Scale (GSRS)
Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation

Full Information

First Posted
November 7, 2019
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04180241
Brief Title
Development of Endoscopic Treatment for Achalasia
Acronym
POEM
Official Title
Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
total division of the muscle layer
Arm Type
Active Comparator
Arm Description
POEM- total division of the circular muscle layer into the gastroesophageal junction
Arm Title
partial division of the muscle layer
Arm Type
Active Comparator
Arm Description
POEM - partial division of the circular muscle layer into the gastroesophageal junction
Intervention Type
Procedure
Intervention Name(s)
POEM
Intervention Description
Peroral endoscopic myotomy
Primary Outcome Measure Information:
Title
The proportion of patients who develop gastroesophageal reflux disease (GERD)
Description
Measured as esophageal acid exposure (pH <4) > 4% of recorded time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Esophageal emptying function
Description
Measured by Time Barium Swallow X-ray
Time Frame
1 year
Title
Eckardt score
Description
The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome.
Time Frame
1 year
Title
RAND-36
Description
The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome.
Time Frame
1 year
Title
Dysmotility
Description
measured by Manometry
Time Frame
1 year
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Thorell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Ersta Hospital
City
Stockholm
State/Province
Region Stockholm
ZIP/Postal Code
SE-116 91
Country
Sweden
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Stockholm County Council
ZIP/Postal Code
116 91
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Development of Endoscopic Treatment for Achalasia

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