Clinical trial NCT06557408: Pancreatic Fistula After Minimally Invasive Enucleation
Official title: Factors Influencing the Occurrence of Pancreatic Fistula After Minimally Invasive Pancreatic Enucleation and Predictive Models: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Tumor, Benign
Pancreatic Neuroendocrine Tumor
Solid Pseudopapillary Tumor of the Pancreas
Keywords: Pancreatic benign or low-grade malignant tumors
Minimally invasive enucleation
Postoperative pancreatic fistula
Prediction model
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of 182 consecutive patients who underwent MIEN at Fudan University Shanghai Cancer Center from July 2019 to November 2022. Nine patients with incomplete clinical data were excluded.

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Clinically Relevant Postoperative Pancreatic Fistula
timeFrame: Within 90 days after surgery.
Secondary outcomes:
measure: Perioperative complication rate according to the Clavien-Dindo classification
timeFrame: Within 90 days after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xianjun Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xiaowu Xu, MD
role: STUDY_DIRECTOR
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