Postoperative Pancreatic FistulaNCT05667272
A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy
An observational study of Postoperative Pancreatic Fistula, run by Changzhou Second People's Hospital affiliated with Nanjing Medical University at 1 site in China.
Trial summary
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pancreatic Fistula
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: (1) Patients with PD or LPD surgery; (2) Surgery performed by the same surgical team.
Who may be able to join
- Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
- Surgery performed by the same surgical team.
Who cannot join
- PD or LPD combined with another organ resection.
- PD or LPD performed due to trauma.
- PD or LPD for emergency treatment, such as the rupture and bleeding of tumor.
- Palliative resection.
- Patients with severe organ dysfunction before surgery.
- Patients treated with preoperative neoadjuvant chemotherapy or other treatments (Radiotherapy, targeted immunotherapy, etc.).
- Patients with missing data for clinical or radiographic variables.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzhou Second People's Hospital affiliated to Nanjing Medical University
Changzhou, Jiangsu
chunfu zhu, phD, +8613961190702, zcfmlm@njmu.edu.cn
About this study
Official title: A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
Read the detailed description
- To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
- Establishment of risk assessment model for Grade B fistula.
- Conditions
- Postoperative Pancreatic Fistula
- Being tested
- No intervention
- Keywords
- postoperative pancreatic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic fistula group | no intervention(s) Receives: Other: No intervention | |
| non-pancreatic fistula group | no intervention(s) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications for each patient
Measured: up to postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Feb 2023
- Primary completion1 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pancreatic FistulaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou Second People's Hospital affiliated with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chunfu zhu, PhD, Study chair, Changzhou Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667272
- Sponsor's protocol ID
- SYuhang
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT05667272
- Acronym / sponsor ID
- SYuhang
- Conditions
- Postoperative Pancreatic Fistula
- Keywords
- postoperative pancreatic fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Changzhou Second People's Hospital affiliated with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 28 Dec 2022 (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.
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
Detailed description
- To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
- Establishment of risk assessment model for Grade B fistula.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic fistula group | – | Other: No interventionno intervention(s) |
| non-pancreatic fistula group | – | Other: No interventionno intervention(s) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- (1) Patients with PD or LPD surgery; (2) Surgery performed by the same surgical team.
Key inclusion criteria (2 listed)
- Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
- Surgery performed by the same surgical team.
Key exclusion criteria (7 listed)
- PD or LPD combined with another organ resection.
- PD or LPD performed due to trauma.
- PD or LPD for emergency treatment, such as the rupture and bleeding of tumor.
- Palliative resection.
- Patients with severe organ dysfunction before surgery.
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 |
|---|---|---|
| No interventionNo intervention | Other | Pancreatic fistula group, non-pancreatic fistula group |
Primary outcome
Postoperative complications
Time frame: up to postoperative 30 days
Postoperative complications for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Results publication: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- 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.
chunfu zhu, PhD study chair
Changzhou Second People's Hospital
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 Postoperative Pancreatic Fistula, run by Changzhou Second People's Hospital affiliated with Nanjing Medical University 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 2 inclusion and 7 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 31 Mar 2023. 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 chunfu zhu, PhD (+8613961190702, zcfmlm@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: up to postoperative 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667272, which also lists 1 linked publication.
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 31 Mar 2023.