NCT06557408Completed
Pancreatic Fistula After Minimally Invasive Enucleation
Factors Influencing the Occurrence of Pancreatic Fistula After Minimally Invasive Pancreatic Enucleation and Predictive Models: a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 7 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 173 (actual)
- First submitted
- 14 Aug 2024
- Start date
- 1 Jul 2019
- Primary completion date
- 30 Nov 2022
- Lead sponsor
- Fudan University
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT06557408
What you commit to
- Study type: Observational
- Participants enrolled: 173
- From 1 Jul 2019 to the primary completion date, 30 Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent presence of other malignant tumors.
Other illness
- Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
Lab values
- 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).
Other
- Missing data due to patient loss of followup, etc.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.