UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial on the effect of neoveil patch on anastomosis in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer
Acronym	neoveil trial in esophageal cancer
Scientific Title	Randomized controlled trial on the effect of neoveil patch on anastomosis in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer
Scientific Title:Acronym	neoveil trial in esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	To verify whether esophageal-gastric or esophageal-jejunum or colon anastomosis with neovale sheet is effective for preventing suture failure in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of anastomotic leakage (Clavin-Dindo Grade 1 or higher) in the esophagus-stomach/jejunum/ileum/colon anastomosis
Key secondary outcomes	Incidence of anastomotic leakage (Clavin-Dindo Grade 3 or higher) in the esophagus-stomach/jejunum/ileum/colon anastomosis, incidence of anastomotic leakage in all anastomoses (Clavin-Dindo Grade 1 or higher), reoperation rate for suture failure, SSI (Surgical) Site infection) Incidence rate, period until the start of postoperative oral intake, number of postoperative hospital stays

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	After performing the anastomosis at the time of surgery, use a neo-veil sheet to wrap it around the anastomosis and reinforce it.
Interventions/Control_2	Do not use Neovale
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	A case of subtotal esophagectomy + subcutaneous reconstruction for histologically confirmed primary esophageal cancer. It does not consider the reconstruction organ or whether it is one-stage reconstruction or two-stage reconstruction. 1. The age at the time of registration is 20 to 85 years old. 2. Progress cT1b-T4b N does not matter M0 does not matter 3. Cases where written consent was obtained.
Key exclusion criteria	1. Cases other than subtotal esophagectomy (eg, lower esophagectomy, cervical esophagectomy, total pharyngeolaryngeal esophagectomy, etc.) 2. Cases with a history of allergy to Neovale sheet In addition, it is judged that registration for this test is inappropriate.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Miyata
Organization	Osaka International Cancer Institute
Division name	Department of gastroenterological surgery
Zip code	541-8567
Address	Osaka-si , Chuoku, Otemae 3-1-69
TEL	06-6945-1181
Email	sugimura-ke@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Keijiro Middle name Last name Sugimura
Organization	Osaka International Cancer Institute
Division name	Department of gastroenterological surgery
Zip code	541-8567
Address	Osaka-si , Chuoku, Otemae 3-1-69
TEL	06-6945-1181
Homepage URL
Email	sugimura-ke@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

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	Osaka International Cancer Institute
Address	Osaka-si , Chuoku, Otemae 3-1-69
Tel	06-6945-1181
Email	rinri01@opho.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	大阪国際がんセンター

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 22 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 06 Day
Date of IRB	2020 Year 07 Month 06 Day
Anticipated trial start date	2020 Year 07 Month 06 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 22 Day
Last modified on	2020 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047276