CompletedNot Applicable

Pancreatic Fistula After Minimally Invasive Enucleation

China173 participantsStarted 2019-07-01

Plain-language summary

Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after MIEN, investigate and develop a personalized predictive model for accurate prediction of CR-POPF.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 70 years, regardless of gender.
✓. Benign or low-grade malignant tumor of the pancreas.
✓. Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
✓. Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
✓. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Willingness to comply with the follow-up programme of the study and other protocol requirements.
✓. Voluntary participation and signed informed consent.

Exclusion criteria

✕. Concurrent presence of other malignant tumors.
✕. Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
✕. Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
✕. Missing data due to patient loss of followup, etc.

What they're measuring

Incidence of Clinically Relevant Postoperative Pancreatic Fistula

Timeframe: Within 90 days after surgery.

Trial details

NCT IDNCT06557408

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-30

View on ClinicalTrials.gov More Pancreatic Tumor, Benign trials