UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029561
Receipt No. R000033774
Scientific Title A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Date of disclosure of the study information 2017/10/16
Last modified on 2018/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Acronym Comparision of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Scientific Title A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Scientific Title:Acronym Comparision of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Region
Japan

Condition
Condition Thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine optimal anastomosis after esophagectomy, we compare circular stapler and modified Collard technique
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of anastomotic stricture
Key secondary outcomes Incidence of anastomotic leakage
Incidence of postoperative complication
Time of anastomosis
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
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 anastomosis by circular stapler
Interventions/Control_2 modified Collard technique 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

Not applicable
Gender Male and Female
Key inclusion criteria 1)thoracic esophageal cancer without infiltration to cervical esophagus
2)radical esophagectomy with lympha node dissection
3)gastric conduit reconstruction through posterior mediastinal route or retrosternal route
4)cervical anastmosis
5)ECOG Performance status 0 to 1
6)sufficient function of important organs
7)written informed consent
Key exclusion criteria 1)Salvage surgery
2)Patients performed preoperative chemoradiotherapy
3)severe complications
4)Patients judged inappropriate for the study by the physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Hosoi
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Aichi
TEL 052-762-6111
Email thosoi@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Hosoi
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Aichi
TEL 052-762-6111
Homepage URL
Email thosoi@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Department of Gastroenterological Surgery
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 愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 16 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
2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 10 Month 15 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.