Predictive Risk Factors for Pancreatic Fistula Grade C Af... | NCT02322424

Studies
Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

NCT02322424

Sponsor

Wakayama Medical University

Status

Unknown status

Last Update Posted

Dec 23, 2014Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Interventions

pancreaticoduodenectomy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Dec 17, 2014

First Posted Date

Dec 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2014

Last Update Posted Date

Dec 23, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hiroki Yamaue, Second Department of Surgery, Wakayama Medical UniversityPrincipal Investigator

Lead Sponsor

Wakayama Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

42 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who undergo pancreaticoduodenectomy			Procedure: pancreaticoduodenectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pancreaticoduodenectomy	Procedure		Patients who undergo pancreaticoduodenectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of pancreatic fistula grade C		90 days after pancreaticoduodenectomy

Secondary Outcomes

Measure	Description	Time Frame
Incidence of overall pancreatic fistula (grade A, grade B and grade C)		90 days after pancreaticoduodenectomy
Incidence of clinical relevant pancreatic fistula (grade B and grade C)		90 days after pancreaticoduodenectomy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients with severe respiratory disorder required oxygen inhalation
patients with severe liver dysfunction
patients with chronic renal failure with dialysis
patients who are unfit for this study as determined by the attending physician

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hiroki Yamaue, M.D., PhD.	Contact	+81-73-441-0613		yamaue-h@wakayama-med.ac.jp
Hiroki Yamaue, M.D., PhD.	Contact	+81-73-441-0613		trial-jt@wakayama-med.ac.jp

Overall Officials

Name	Affiliation	Role
Hiroki Yamaue, M.D., PhD.	Wakayama Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gun Memorial Hospital	Recruiting	Linkou District			Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D016577	Pancreaticoduodenectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided