Clinical trial · Observational
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
NCT06557408CI-TRIAL-00082355completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Tumor, Benign | Benign Pancreatic Neoplasm | ALIAS | 0.90 |
| Solid Pseudopapillary Tumor of the Pancreas | Solid Pseudopapillary Neoplasm of the Pancreas | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (1)
- measure
- Incidence of Clinically Relevant Postoperative Pancreatic Fistula
- timeFrame
- Within 90 days after surgery.
- description
- Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
Secondary outcomes (1)
- measure
- Perioperative complication rate according to the Clavien-Dindo classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDCrippa S, Bassi C, Salvia R, Falconi M, Butturini G, Pederzoli P. Enucleation of pancreatic neoplasms. Br J Surg. 2007 Oct;94(10):1254-9. doi: 10.1002/bjs.5833. PMID 17583892
- BACKGROUNDZhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9. PMID 27423534
- BACKGROUNDCauley CE, Pitt HA, Ziegler KM, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Lillemoe KD. Pancreatic enucleation: improved outcomes compared to resection. J Gastrointest Surg. 2012 Jul;16(7):1347-53. doi: 10.1007/s11605-012-1893-7. Epub 2012 Apr 24. PMID 22528577
- BACKGROUNDGiuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14. PMID 33856383
- BACKGROUNDDuconseil P, Marchese U, Ewald J, Giovannini M, Mokart D, Delpero JR, Turrini O. A pancreatic zone at higher risk of fistula after enucleation. World J Surg Oncol. 2018 Aug 29;16(1):177. doi: 10.1186/s12957-018-1476-5. PMID 30157952
- BACKGROUNDHuttner FJ, Koessler-Ebs J, Hackert T, Ulrich A, Buchler MW, Diener MK. Meta-analysis of surgical outcome after enucleation versus standard resection for pancreatic neoplasms. Br J Surg. 2015 Aug;102(9):1026-36. doi: 10.1002/bjs.9819. Epub 2015 Jun 4. PMID 26041666
- BACKGROUNDLi Z, Zhuo Q, Shi Y, Chen H, Liu M, Liu W, Xu W, Chen C, Ji S, Yu X, Xu X. Minimally invasive enucleation of pancreatic tumors: The main pancreatic duct is no longer a restricted area. Heliyon. 2023 Nov 7;9(11):e21917. doi: 10.1016/j.heliyon.2023.e21917. eCollection 2023 Nov.