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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004848
Receipt No. 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

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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
Email

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
Email makoto@wakayama-med.ac.jp

Sponsor
Institute Second Department of Surgey
Wakayama Medical Univesity
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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