UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022890 |
|---|---|
| Receipt number | R000026380 |
| Scientific Title | Esophageal motility before and after endoscopic submucosal dissection for superficial esophageal cancer: A high resolution manometry study |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2016/06/26 13:40:02 |
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Basic information
Public title
Esophageal motility before and after endoscopic submucosal dissection for superficial esophageal cancer: A high resolution manometry study
Acronym
Esophageal motility before and after endoscopic submucosal dissection for superficial esophageal cancer: A high resolution manometry study
Scientific Title
Esophageal motility before and after endoscopic submucosal dissection for superficial esophageal cancer: A high resolution manometry study
Scientific Title:Acronym
Esophageal motility before and after endoscopic submucosal dissection for superficial esophageal cancer: A high resolution manometry study
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to elucidate the esophageal motility before and after ESD and the cause of dysphagia using high resolution manometry (HRM).
Basic objectives2
Others
Basic objectives -Others
To elucidate the effect of ESD for superficial esophageal cancer on esophageal motility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
esophageal motility before and after ESD
Key secondary outcomes
dysphagia before and after ESD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Each patient underwent HRM and filled out a questionnaire on dysphagia before ESD was performed.After scarring of ESD ulcer was confirmed by endoscopy, patients underwent second HRM and filled out the questionnaire again. When postoperative stricture occurred, stricture preventions were performed until post-operative stricture disappeared and then, patients underwent second HRM and filled out the questionnaire.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Twenty patients who were going to undergo ESD for superficial EC between September 2013 and February 2015 at Niigata University Hospital, were enrolled in this study.
Key exclusion criteria
Patients who needed any additional anticancer therapy (surgery, chemotherapy, and/or irradiation) after ESD were excluded. The patients whose HRM results were poor were also excluded from the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
+81-25-223-2207
kazuya911@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
+81-25-223-2207
Homepage URL
kazuya911@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology,Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
新潟大学医歯学総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 26 | Day |
Last modified on
| 2016 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026380
