A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy
1 other identifier
observational
216
1 country
1
Brief Summary
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedMarch 31, 2023
March 1, 2023
3 months
December 19, 2022
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications
Postoperative complications for each patient
up to postoperative 30 days
Study Arms (2)
Pancreatic fistula group
no intervention(s)
non-pancreatic fistula group
no intervention(s)
Interventions
Eligibility Criteria
(1) Patients with PD or LPD surgery; (2) Surgery performed by the same surgical team.
You may qualify if:
- Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
- Surgery performed by the same surgical team.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changzhou Second People's Hospital affiliated to Nanjing Medical University
Changzhou, Jiangsu, China
Related Publications (1)
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.
PMID: 28040257RESULT
Study Officials
- STUDY CHAIR
chunfu zhu, PhD
Changzhou Second People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2022
First Posted
December 28, 2022
Study Start
February 1, 2023
Primary Completion
May 1, 2023
Study Completion
May 31, 2023
Last Updated
March 31, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share