UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of cervical esophagogastric anastomosis after eophagectomy: a prospective randomized controlled study
Acronym	Evaluation of cervical esophagogastric anastomosis after eophagectomy
Scientific Title	Evaluation of cervical esophagogastric anastomosis after eophagectomy: a prospective randomized controlled study
Scientific Title:Acronym	Evaluation of cervical 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	By comparing the triangle anastomosis with linear stapler and modified Collard technique, we evaluate postoperative complications such as anastomotic stricture and anastomotic leakage in both method, and identify optimal anastomosing method.
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
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	anastomosis by triangle method
Interventions/Control_2	anastomosis by modified Collard method
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 triangle anastomosis by linear stapler or the anastomosis by modified Collard method is not able to be performed. 2)severe complication such as interstitial pneumonia, uncontrolled DM, ischemic heart disease, cardiac failure 3)liver cirrhosis, active hapatitis 4)haemodialysis
Target sample size	125

Research contact person
Name of lead principal investigator	1st name Mikihito Middle name Last name Nakamori
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	chamcham@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Nakamori Middle name Last name Nakamori
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	chamcham@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	Wakayama Medical University
Address	811-1 Kimiidera , Wakayama
Tel	073-447-2300
Email	keiji@wakayama-med.ac.jp

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	2017 Year 01 Month 13 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 01 Month 11 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 16 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 01 Month 11 Day
Last modified on	2019 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029490