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

March 30, 2023 updated by: Changzhou Second People's Hospital affiliated with Nanjing Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • Changzhou Second People's Hospital affiliated to Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

(1) Patients with PD or LPD surgery; (2) Surgery performed by the same surgical team.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: up to postoperative 30 days
Postoperative complications for each patient
up to postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changzhou Second People's Hospital affiliated with Nanjing Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYuhang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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