Development of Endoscopic Treatment for Achalasia

NCT04180241 | Active Not Recruiting

• 1 other identifier: 2017/1630-31
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who develop gastroesophageal reflux disease (GERD)

  Measured as esophageal acid exposure (pH \<4) \> 4% of recorded time

  1 year

Secondary Outcomes (5)

• Esophageal emptying function

  1 year

• Eckardt score

  1 year

• RAND-36

  1 year

• Dysmotility

  1 year

• Gastrointestinal Symptom Rating Scale (GSRS)

  1 year

Study Arms (2)

total division of the muscle layer

ACTIVE COMPARATOR

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

Procedure: POEM

partial division of the muscle layer

ACTIVE COMPARATOR

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

Procedure: POEM

Interventions

POEM PROCEDURE

Peroral endoscopic myotomy

partial division of the muscle layer; total division of the muscle layer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska Institutet, Ersta Hospital

Stockholm, Region Stockholm, SE-116 91, Sweden

Location

Karolinska Institutet

Stockholm, Stockholm County Council, 116 91, Sweden

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anders Thorell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 27, 2019
• Study Start: April 15, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

SE (2)