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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047276


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name