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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study focused specifically on pancreatic fistula after minimally invasive enucleation — if my tumor is the type that might be treated this way, how likely is a fistula, and what would that mean for my recovery?
2Since this trial is already completed, has my care team seen or reviewed its findings, and do those results change how they'd approach my surgery compared to more extensive procedures like a distal pancreatectomy?
3The trial included several types of tumors — benign pancreatic tumors, neuroendocrine tumors, and solid pseudopapillary tumors — so based on my specific diagnosis, does enucleation even make sense for me, or would a different operation be safer?
4Because this was a Phase NA observational-style study measuring complication rates rather than testing a new treatment, what does that mean in terms of how confident my doctor can be about the safety data when applying it to my situation?
5If pancreatic fistula is a known risk after enucleation, what signs should I watch for after surgery, and how does my doctor's team typically manage that complication if it does happen?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
. 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.