UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004848 |
|---|---|
| Receipt number | R000005772 |
| Scientific Title | Evaluation of esophagogastric anastomosis after eophagectomy: a prospective randomized controlled study |
| Date of disclosure of the study information | 2011/01/09 |
| Last modified on | 2012/01/11 11:22:32 |
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Basic information
Public title
Evaluation of esophagogastric anastomosis after eophagectomy: a prospective randomized controlled study
Acronym
Evaluation of esophagogastric anastomosis after eophagectomy
Scientific Title
Evaluation of esophagogastric anastomosis after eophagectomy: a prospective randomized controlled study
Scientific Title:Acronym
Evaluation of esophagogastric anastomosis after eophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compare triangle anastomosis by linear stapler with machine anastomosis by circular staplercompare postoperative complications such as postoperative anastomotic stricture or in both anastomosis method by and determine optimal anastomosis method after the esophagectomy rebuilding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of the anastomotic stricture
Key secondary outcomes
Incidence of the anastomotic leakage
Incidence of the aspiration pneumonitis
Incidence of the postoperative complication
Incidence of the reflux esophagitis
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
anastomosis by circular stapler
Interventions/Control_2
anastomosis by triangle method by linear stapler
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)thoracic esohageal cancer without infiltration to cervical esophagus
2)gastric conduit reconstruction through posterior mediatinal route or retrosternalroute
3)cervical approach for anastomosis
4)2 fields or 3 fields lymph node dissection
5)no severe disturbance of liver function and renal function
6)an age of 80 years or younger
7)writen informed consent
Key exclusion criteria
1)Either of the anastomosis using circular stapler or the triangle anastomosis by linear stapler is not able to be performed judged by operative finding
2)severe complication such as interstitial pneumonia, uncontrolled DM, ischemic heart disease, cardiac failure
3)liver cirrhosis, active hapatitis
4)haemodialysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Iwahashi |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Iwahashi |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
TEL
Homepage URL
makoto@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgey
Wakayama Medical Univesity
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgey
Wakayama Medical Univesity
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | 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
| 2011 | Year | 01 | Month | 09 | Day |
Last modified on
| 2012 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
