Pancreatic Fistula After Minimally Invasive Enucleation

Fudan University173 enrolled

Overview

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.

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 compared to standard pancreatectomy. However, the incidence of postoperative pancreatic fistula (POPF) after MIEN is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. POPF is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic MIEN. Although risk factors and predictive models for POPF in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for MEN. With the increasing adoption of MIEN, there is an urgent need for a predictive model to guide the treatment and prognosis of POPF. Therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. The result of this study will provide a valuable reference for the development and application of MIEN.

Study Type

OBSERVATIONAL

Enrollment

173

Conditions

Pancreatic Tumor, Benign Pancreatic Neuroendocrine Tumor Solid Pseudopapillary Tumor of the Pancreas

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 70 years, regardless of gender. 2. Benign or low-grade malignant tumor of the pancreas. 3. Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery. 4. Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation. 5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Willingness to comply with the follow-up programme of the study and other protocol requirements. 7. Voluntary participation and signed informed consent. Exclusion Criteria: 1. Concurrent presence of other malignant tumors. 2. Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead. 3. 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). 4. Missing data due to patient loss of followup, etc.

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Incidence of Clinically Relevant Postoperative Pancreatic Fistula

Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.

Time frame: Within 90 days after surgery.

Secondary Outcomes

Perioperative complication rate according to the Clavien-Dindo classification

Adverse events occurring during or after surgery reported according to the Clavien-Dindo classification.

Time frame: Within 90 days after surgery.

Data from ClinicalTrials.gov

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