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Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

NCT ID: NCT02322424

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-06-30

Brief Summary

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Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors for grade C PF by Japan and Taiwan cooperative project.

Detailed Description

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Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). The rate of grade C PF has been reported 2.5-6%, however, it is critical complication after PD. A large number of enrolled patients will be needed to clarify the risk factors for grade C PF. Therefore, this study design is prospective large observational study at multi-center in Japan and Taiwan.

Conditions

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Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who undergo pancreaticoduodenectomy

pancreaticoduodenectomy

Intervention Type PROCEDURE

Interventions

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pancreaticoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
2. Age: 20 years or older
3. PS (ECOG performance status scale) 0-1 at the time of enrollment
4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

1. patients with severe respiratory disorder required oxygen inhalation
2. patients with severe liver dysfunction
3. patients with chronic renal failure with dialysis
4. patients who are unfit for this study as determined by the attending physician
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hiroki Yamaue

Second Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroki Yamaue, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Wakayama Medical University

Locations

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Chang Gun Memorial Hospital

Linkou District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hiroki Yamaue, M.D., PhD.

Role: CONTACT

Phone: +81-73-441-0613

Email: [email protected]

Hiroki Yamaue, M.D., PhD.

Role: CONTACT

Phone: +81-73-441-0613

Email: [email protected]

Facility Contacts

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Tsann-Long Hwang, M.D., PhD.

Role: primary

Other Identifiers

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Japan-Taiwan PD Project

Identifier Type: -

Identifier Source: org_study_id