UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Robotic surgery for Achalasia
Title of the study (Brief title)	Robotic surgery for Achalasia
Region	Japan

Condition
Condition	Achalasia
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of safety and efficiency of robotic surgery for achalasia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety and efficiency
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Robotic surgery
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Esophageal achalasia 2. Age: 20 and more, 79 or younger. 3.Performance Status (ECOG):0 or1 4.At least 4 weeks has been past since previous treatments 5.Appropriate organ functions are preserved.
Key exclusion criteria	1. Obvious infection 2. Severe hypo alimentation 3. Uncontrorable pleural effusion, ascites, pericardial effusion 4. Severe heart failure 5. Severe complication 6. Psychiatric disorders 7. Active cancers 8. Steroid usage 9. Hepatitis, HIV positive, HTLV-1 Positive 10. Hyper sensitivity for albumin 11. Pregnant woman 12. Autoimmune diseases
Target sample size	5

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Chiba University
Division name	Department of GI-Surgery
Address	1-8-1, Inohana, Chuoku, Chiba
TEL	043-222-7171
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	Yasunori Akutsu
Organization	Chiba University
Division name	Department of Frontier Surgery
Address	1-8-1, Inohana, Chuoku, Chiba
TEL	043-226-2110
Homepage URL
Email	yakutsu@faculty.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	2013 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 25 Day
Anticipated trial start date	2013 Year 05 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

Management information
Registered date	2013 Year 06 Month 30 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012970