UMIN-CTR Clinical Trial

Basic information
Public title	Examination of effectiveness of POEM for sigmoid-type achalasia and improvement of esophageal deviation / meandering
Acronym	Examination of effectiveness of POEM for sigmoid-type achalasia and improvement of esophageal deviation / meandering
Scientific Title	Examination of effectiveness of POEM for sigmoid-type achalasia and improvement of esophageal deviation / meandering
Scientific Title:Acronym	Examination of effectiveness of POEM for sigmoid-type achalasia and improvement of esophageal deviation / meandering
Region	Japan

Condition
Condition	sigmoid-type achalasia
Classification by specialty	Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the long-term outcome, including efficacy, safety, and morphological changes of POEM for sigmoid esophageal achalasia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of treatment outcomes for linear and sigmoid achalasia
Key secondary outcomes	1) Comparison of the rate of change in Eckardt score between linear achalasia and sigmoid achalasia 2) Comparison of adverse events between linear achalasia and sigmoid achalasia 3) Comparison of the incidence of reflux esophagitis between linear achalasia and sigmoid achalasia 4) Long-term results of Eckardt score in sigmoid type achalasia 5) Evaluation of improvement of esophageal flexion in sigmoid type achalasia (treatment evaluation and long-term course)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have been examined, diagnosed, and treated at Oita University Hospital 2) Cases aged 20 years or older at the time of treatment
Key exclusion criteria	Cases that offered to disagree with this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Ogawa
Organization	Oita University, Faculty of medicine
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1, idaigaoka, Hasama, Yufu, Oita
TEL	097-586-6193
Email	ogawaryo@oita-u.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Mizukami
Organization	Oita University, Faculty of medicine
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1, idaigaoka, Hasama, Yufu, Oita
TEL	097-586-6193
Homepage URL
Email	mizkaz0809@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

Funding Source
Organization	Oita University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Oita University, Faculty of Medicine
Address	1-1, idaigaoka, Hasama, Yufu, Oita
Tel	097-586-6380
Email	rinrikenkyu@oita-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 15 Day
Date of IRB	2021 Year 10 Month 25 Day
Anticipated trial start date	2021 Year 12 Month 05 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a retrospective study that examines the therapeutic effect, safety, and long-term course of patients who underwent POEM at Oita University Hospital. Medical information is obtained from medical records and examination records.

Management information
Registered date	2021 Year 12 Month 05 Day
Last modified on	2021 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052812