Status:
COMPLETED
Pancreatic Fistula After Minimally Invasive Enucleation
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Tumor, Benign
Pancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18-70 years
Brief 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 fro...
Detailed Description
Minimally invasive enucleation (MIEN) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT06557408
Start Date
July 1 2019
End Date
July 30 2024
Last Update
November 7 2024
Active Locations (1)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
Shanghai, Shanghai Municipality, China