UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on the usefulness of muscle layer ressection biopsy for muscle layer biopsy for patients with esophageal achalasia who underwent per-oral endoscopic myotomy
Title of the study (Brief title)	Clinical study on the usefulness of muscule layer ressection biopsy for muscule layer biopsy for patients with esophagus achalasia
Region	Japan

Condition
Condition	esophageal achalasia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of histopathological evaluation of muscle layer resection biopsy (MRB) compared to muscle layer biopsy (MB) for esophageal achalasia patients and achalasia related diseases who underwent peroral endoscopic myotomy (POEM).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Comparison of the number of Auerbach's myentric plexus per muscular specimen of LES part collected by using MB and MRB.
Key secondary outcomes

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) The age at the time of consent acquisition is 20 years old or over. (2) Patients who are diagnosed as esophageal achalasia and achalasia related diseases by using endoscopy, esophagram and high resolution manometry. (3) symptomatic patients with Eckardt symptom score 3 or more. (4) Patients who will undergo POEM. (5) Document consents are obtained from the subjects prior to this research.
Key exclusion criteria	(1) Patients who can not obtain consent from himself / herself. (2) Patients under 20 years old. (3) Patients who take antithrombotic drugs (4) Patients underwent POEM or surgical myotomy before this research. (5) Patients who are considered inappropriate for this research by the research director.
Target sample size	39

Research contact person
Name of lead principal investigator	Hirofumi Abe
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL	078-382-5774
Email	abe627@med.kobe-u.ac.jp

Public contact
Name of contact person	Hirofumi Abe
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL	078-382-5774
Homepage URL
Email	abe627@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 21 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Consecutive series of patients who will undergo POEM in our hospital from Febrary 1, 2019 are enrolled in this study. The collection of full-thickness muscle layer are performed by using both muscle layer biopsy and muscle layer ressection biopsy among same patients and the usefullness for histopathological examination are compared each other.

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040188