UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015384
Receipt number R000017893
Scientific Title A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy
Date of disclosure of the study information 2014/10/16
Last modified on 2016/07/19 22:32:47

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Basic information

Public title

A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy

Acronym

A Prospective, Multi-center Investigation of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy

Scientific Title

A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy

Scientific Title:Acronym

A Prospective, Multi-center Investigation of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy

Region

Japan


Condition

Condition

disease of pancreatic body and tail

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the impact of the Endo GIA Reinforced Reload with Tri-Staple technology during distal pancreatectomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Incidence of pancreatic fistula grade B and grade C defined by International Study Group of Postoperative Pancreatic Fistula(ISGPF)

Key secondary outcomes

1.Incidence of pancreatic fistula defined by ISGPF classification
2.Incidence of pancreatic fistula grade C defined by ISGPF classification
3.Incidence ofintraabdominal bleeding
4.Morbidity
5.Mortality
6.Postoperative hospital stay
7.Hemostasis condition of staple line
8.Malformationof staple line
9.Period of drain insertion
10.Damage of pancreatic stump
11.Frequency of additional suture of pancreatic stump
12.Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

the Endo GIA Reinforced Reload with Tri-Staple technology

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) disease of pancreatic body and tail
2) PS (ECOG Performance Status Scale)0-1
3) Age: 20 years or older
4) distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
5) Patients who can provide written informed consent

Key exclusion criteria

1) Patients with severe ischemic cardiac disease
2) Patients with severe liver cirrhosis or active hepatitis
3) Patients with respiratory illness that requires oxygen administration
4) Patients with chronic renal failure requiring dialysis
5) Patients requiring other organ resection
6) Others, patients who are unfit for the study as determined by the attending physician

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Yamaue

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Email

yamaue-h@wakayaam-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Kawai

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Homepage URL


Email

kawai@wakayaam-med.ac.jp


Sponsor or person

Institute

Second Department of Surgery, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Second Department of Surgery, Wakayama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

1. Department of Gastroenterological Surgery, Osaka University
2. Department of Surgery, Kansai Medical University
3.Department of Surgery, Kansai Rosai Hospital
4.Department of Surgery, Kyoto Prefectural University of Medicine
5.Department of Surgery, Kinki University
6.Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
7.Department of Surgery, Nara Medical University
8.Second Department of Surgery, Nagoya University
9.Department of HPB Surgery, Hyogo College of Medicine
10.Department of Surgery, Hiroshima University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 10 Month 16 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

Completed

Date of protocol fixation

2014 Year 09 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 16 Day

Last follow-up date

2015 Year 08 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2016 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017893


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name