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A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

Sponsor
Changzhou Second People's Hospital affiliated with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05667272
Collaborator
(none)
216
Enrollment
1
Location
3.9
Anticipated Duration (Months)
55.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

  1. To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

  2. Establishment of risk assessment model for Grade B fistula.

Study Design

Study Type:
Observational
Anticipated Enrollment :
216 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Pancreatic fistula group

no intervention(s)

Other: No intervention
No intervention
non-pancreatic fistula group

no intervention(s)

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Postoperative complications [up to postoperative 30 days]

    Postoperative complications for each patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changzhou Second People's Hospital affiliated to Nanjing Medical University Changzhou Jiangsu China

Sponsors and Collaborators

  • Changzhou Second People's Hospital affiliated with Nanjing Medical University

Investigators

  • Study Chair: chunfu zhu, PhD, Changzhou Second People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changzhou Second People's Hospital affiliated with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05667272
Other Study ID Numbers:
  • SYuhang
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changzhou Second People's Hospital affiliated with Nanjing Medical University
postoperative pancreatic fistula
Additional relevant MeSH terms:
Pancreatic Fistula
Fistula

Study Results

No Results Posted as of Dec 28, 2022