NCT05667272RecruitingNot Applicable
A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy
Changzhou Second People's Hospital affiliated with Nanjing Medical University1 site in 1 country216 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Postoperative complications
Study Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
- •Surgery performed by the same surgical team.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Postoperative complications
Time Frame: up to postoperative 30 days
Postoperative complications for each patient
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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