UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039413
Receipt number R000044938
Scientific Title Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Date of disclosure of the study information 2020/02/07
Last modified on 2020/02/06 19:35:00

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Basic information

Public title

Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

Acronym

Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

Scientific Title

Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

Scientific Title:Acronym

Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the incidences of anastomotic leakage

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

incidences of anastomotic leakage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

PDSII is used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

Interventions/Control_2

LACLON is used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy

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

patients who received posterior mediastinal gastric conduit reconstruction with layer-to-layer handsewn anastomosis

Key exclusion criteria

patients who received other reconstruction organ and route

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Sato

Organization

Akita University Hospital

Division name

Esophageal surgery

Zip code

010-8543

Address

1-1-1, Hondo, Akita city, Japan

TEL

+81-18-884-6132

Email

yusuke@doc.med.aktia-u.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Sato

Organization

Akita University Hospital

Division name

Esophageal surgery

Zip code

010-8543

Address

1-1-1, Hondo, Akita city, Japan

TEL

+81-18-884-6132

Homepage URL


Email

yusuke@doc.med.aktia-u.ac.jp


Sponsor or person

Institute

Akita University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Akita University Graduate School of Medicine

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

Akita University Graduate School of Medicine

Address

1-1-1, Hondo, Akita city, Japan

Tel

+81-18-884-6132

Email

yusuke@doc.med.aktia-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1

2306

Org. issuing International ID_1

Akita University Graduate School of Medicine

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 07 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

2019 Year 08 Month 27 Day

Date of IRB

2019 Year 10 Month 18 Day

Anticipated trial start date

2019 Year 10 Month 18 Day

Last follow-up date

2021 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 02 Month 06 Day

Last modified on

2020 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044938


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name