Catharina Ziekenhuis

Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters/endpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating:
* The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care
* Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care
* Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care
* Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care
* Patients' and doctors' use of and experiences with the ENDORISK-model
* Impact of ENDORISK on regional care costs

This is a phase II study conducted in three hospitals in the Netherlands (Erasmus MC in Rotterdam, Catharina Hospital in Eindhoven, and the Netherlands Cancer Institute in Amsterdam). A total of 49 patients will take part. The aim is to test whether a new combination treatment is feasible for patients with gastric peritoneal metastases (PM). The treatment includes chemotherapy (intraperitoneal irinotecan and standard systemic therapy such as CAPOX or FOLFOX), and may also include nivolumab or trastuzumab, depending on biomarker results.

The PANENCA trial aims to reduce postoperative complications for patients who need a pancreatoduodenectomy (also known as a Whipple procedure), which is a complex operation to remove a tumor from or near the head of the pancreas. One of the most serious and common complications after this surgery is a leak from the pancreas, called a postoperative pancreatic fistula (POPF). Such leaks can cause infection, bleeding, or inflammation in the abdomen, often leading to delayed recovery and postponement of the next phase of treatment. In severe cases, these complications can even result in death.
Patients with a small pancreatic duct (3 millimeters or less) are known to have a higher risk of developing a leak. Previous studies suggest that several existing treatments may help to prevent these complications. These include hydrocortisone, a medicine that reduces inflammation; octreotide, a medicine that decreases the production of pancreatic juices; and a surgical technique called the teres ligament patch, which uses the patient's own tissue to protect nearby blood vessels if a leak occurs.
Because pancreatic fistulas are complex and multifactorial, we believe that a combination therapy targeting different mechanisms may provide a complementary and stronger protective effect. Therefore, the PANENCA trial will investigate whether using these three interventions together can reduce major complications after surgery. Patients who take part in the study will be randomly assigned to receive either the combination treatment or standard care. The medicines are given only during the first few days after surgery, and the patch is placed during the operation. No additional tests, monitoring, or hospital visits are required beyond normal care.
This international, multicenter trial includes high-risk patients undergoing pancreatoduodenectomy. The main goal is to determine whether the combination therapy can lower the rate of major postoperative complications. If proven effective, this approach will be implemented consistently across Europe and incorporated into international treatment guidelines for pancreatic surgery.