Disease of Pancreatic Head or Periampullary Lesions to Require PancreaticoduodenectomyNCT02322424
Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy
An observational study of Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy, run by Wakayama Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Jun 2017
- How long will I take part?
- 42 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gun Memorial Hospital
Linkou District
Tsann-Long Hwang, M.D., PhD.
About this study
Official title: Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study
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.
Read the 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.
- Being tested
- pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo pancreaticoduodenectomy | Not described Receives: Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula grade C
Measured: 90 days after pancreaticoduodenectomy
Secondary outcomes (8)
Incidence of overall pancreatic fistula (grade A, grade B and grade C)
Measured: 90 days after pancreaticoduodenectomy
Incidence of clinical relevant pancreatic fistula (grade B and grade C)
Measured: 90 days after pancreaticoduodenectomy
Incidence of postpancreatecomy hemorrhage(PPH)
Measured: 90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B
Measured: 90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
Measured: 90 days after pancreaticoduodenectomy
Morbidity
Measured: 90 days after pancreaticoduodenectomy
30-day mortality
Measured: 30 days after pancreaticoduodenectomy
90-day mortality
Measured: 90 days after pancreaticoduodenectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease of Pancreatic Head or Periampullary Lesions to Require PancreaticoduodenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 42 Months
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- Hiroki Yamaue, M.D., PhD., Principal investigator, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322424
- Sponsor's protocol ID
- Japan-Taiwan PD Project
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study
- ClinicalTrials.gov ID
- NCT02322424
- Acronym / sponsor ID
- Japan-Taiwan PD Project
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 42 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo pancreaticoduodenectomy | – | Procedure: pancreaticoduodenectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreaticoduodenectomy | Procedure or surgery | Patients who undergo pancreaticoduodenectomy |
Primary outcome
Incidence of pancreatic fistula grade C
Time frame: 90 days after pancreaticoduodenectomy
8 secondary outcomes
Incidence of overall pancreatic fistula (grade A, grade B and grade C)
Time frame: 90 days after pancreaticoduodenectomy
Incidence of clinical relevant pancreatic fistula (grade B and grade C)
Time frame: 90 days after pancreaticoduodenectomy
Incidence of postpancreatecomy hemorrhage(PPH)
Time frame: 90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B
Time frame: 90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
Time frame: 90 days after pancreaticoduodenectomy
Morbidity
Time frame: 90 days after pancreaticoduodenectomy
30-day mortality
Time frame: 30 days after pancreaticoduodenectomy
90-day mortality
Time frame: 90 days after pancreaticoduodenectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroki Yamaue, M.D., PhD. principal investigator
Wakayama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy, run by Wakayama Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroki Yamaue, M.D., PhD. (+81-73-441-0613, yamaue-h@wakayama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pancreatic fistula grade C (time frame: 90 days after pancreaticoduodenectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.