Pancreatic Fistula After Minimally Invasive Enucleation

Fudan University

Status: Completed

Conditions: Pancreatic Tumor, Benign; Solid Pseudopapillary Tumor of the Pancreas; Pancreatic Neuroendocrine Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT06557408

CSPAC-MIEN-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

173 participants in 1 patient group

Minimally invasive enucleation cohort

Description:

Surgical approaches to minimally invasive enucleation include laparoscopic or robotic-assisted procedures. During surgery, intraoperative ultrasonography is used to verify the position of the tumour in relation to the main pancreatic duct to ensure that injury to the main pancreatic duct is avoided and to help identify tumours within the pancreatic parenchyma. If injury to the main pancreatic duct is unavoidable, suture repair or bridging reconstruction techniques are used. If intraoperative freezing reveals the presence of high-grade dysplasia or invasive cancer, the procedure is converted to an oncological resection.