UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041516 |
|---|---|
| Receipt number | R000047276 |
| Scientific Title | Randomized controlled trial on the effect of neoveil patch on anastomosis in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer |
| Date of disclosure of the study information | 2020/08/22 |
| Last modified on | 2020/08/22 12:03:35 |
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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
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
sugimura-ke@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047276
