Pancreatic CancerNCT03129607
A Study in Postoperative Pancreatic Fistula
An observational study of Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with diagnosed POPF
Who may be able to join
- Must have a diagnosis of POPF;
- Aged 18 or older;
- Of either sex.
Who cannot join
- No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: An Observational Retrospective Study in Postoperative Pancreatic Fistula
The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.
Read the detailed description
The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.
- Conditions
- Pancreatic Cancer
- Keywords
- POPF, Classification system
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POPF group | Patients who had POPF will be included into POPF group. | |
| Observation group | Patients without POPF will be included into observation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Secondary outcomes (3)
Hospital stays
Post-operation hospital stay is assessed
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Number of hospitalizations
Number of hospitalizations during the observational period
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Mortality
Postoperative death in 30 days are considered concerned with pancreatic fistula
Measured: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting-Bo Liang, phD, Study chair, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129607
- Sponsor's protocol ID
- SAHZhejiangU06
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Retrospective Study in Postoperative Pancreatic Fistula
- ClinicalTrials.gov ID
- NCT03129607
- Acronym / sponsor ID
- SAHZhejiangU06
- Conditions
- Pancreatic Cancer
- Keywords
- POPF, Classification system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 26 Apr 2017 (actual)
- 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.
The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.
Detailed description
The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POPF group | – | –Patients who had POPF will be included into POPF group. |
| Observation group | – | –Patients without POPF will be included into observation group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with diagnosed POPF
Key inclusion criteria (3 listed)
- Must have a diagnosis of POPF;
- Aged 18 or older;
- Of either sex.
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pancreatic fistula
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria
3 secondary outcomes
Hospital stays
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Number of hospitalizations
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Mortality
Time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Ting-Bo Liang, phD study chair
Second Affiliated Hospital of Zhejiang University School of Medicine
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 Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 1 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 9 Oct 2017. 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 China. 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 Xue-Li Bai, phD (+86 571 87783510, shirleybai57@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic fistula (time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days). 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 9 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.