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

NCT ID: NCT05667272

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pancreatic Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pancreatic fistula group

no intervention(s)

No intervention

Intervention Type OTHER

No intervention

non-pancreatic fistula group

no intervention(s)

No intervention

Intervention Type OTHER

No intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changzhou Second People's Hospital affiliated with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

chunfu zhu, PhD

Role: STUDY_CHAIR

Changzhou Second People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changzhou Second People's Hospital affiliated to Nanjing Medical University

Changzhou, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

chunfu zhu, PhD

Role: CONTACT

+8613961190702

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

chunfu zhu, phD

Role: primary

+8613961190702

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28040257 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SYuhang

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pancreas Cancer Surveillance Using an Abbreviated MRI
NCT04592393 ACTIVE_NOT_RECRUITING NA