ToPanc - Study: Does complete removal of the pancreas in patients with cancer in the head of the pancreas lead to a higher life expectancy than partial removal of the pancreas?

Certain types of cancer in the head of the pancreas are very aggressive. However, healing is possible through complete surgical removal and additional chemotherapy.
To remove a tumor in the head of the pancreas, partial removal of the pancreas with a connection of the remaining pancreas to the small intestine or stomach is the surgical standard. The worst complication of this operation is the development of a leaking connection with the release of aggressive pancreatic juice into the abdominal cavity, known as a fistula. To avoid the development of a fistula, the entire pancreas can also be removed. Subsequently, the functions of the pancreas (production of digestive enzymes as well as production of insulin and other hormones for blood sugar regulation) must be replaced with medications. This used to be complicated, and patients had a poor quality of life. However, the introduction of new insulin delivery systems has significantly changed this in recent years. Many studies have shown that the quality of life and the complication and mortality rates are now as good as after partial removal.
Our research question is: Is performing a complete pancreas removal in patients at high risk for a postoperative fistula better than just partial removal with a connection of the remaining pancreas? For this purpose, we want to assign patients to a standard group (partial removal of the pancreas) and an intervention group (complete removal of the pancreas). After the operation, many data points such as recovery after surgery, time until the start of chemotherapy, overall survival, and many more will be evaluated. A central point will be the quality of life of the patients regarding blood sugar control.

For our study, we want to assign patients with cancer in the head of the pancreas and a high risk of fistula into two groups:
1. Standard group with partial pancreas removal. This is the current surgical standard for a tumor in the head of the pancreas. During removal, the duodenum and the bile duct running through the head must also be removed. Subsequently, three new connections are sewn to ensure digestion: the remaining pancreas body to the small intestine or stomach, the remaining bile duct to the small intestine, and the stomach outlet to the small intestine. This is an approximately six-hour operation, which leads to complications in about 20-30% of cases even in large centers. One of the worst complications is a leak at the pancreas connection with the outflow of pancreatic juice into the immediate surroundings. This is called a fistula. The juice attacks the surrounding tissue due to its chemical properties, which can lead to severe bleeding and infections, even sepsis. Sometimes, another surgery is necessary, and the remaining pancreas must be removed. Many scientific studies show that patients with such a fistula have worse short- and long-term survival. One reason for this is that patients with such severe complications are often too weak to receive subsequent chemotherapy. Therefore, many surgeons already perform complete removal of the pancreas in cases of a risk situation for a fistula (Point 2).

2. Intervention group with complete pancreas removal. The complete removal of the pancreas has the advantage that the risk of fistula formation is eliminated. Only two instead of three new connections need to be created: one connection from the bile duct to the small intestine and one connection from the stomach to the small intestine. Due to the absence of the pancreas, the dangerous pancreatic fistula can no longer develop. What is often not known is that one can live without a pancreas. However, one is dependent for life on the replacement of digestive enzymes through tablets and insulin through injections or a pump (one is therefore an insulin-dependent diabetic). In the past, blood sugar control was difficult, and the quality of life after such operations was low. Recent developments in automatic, continuous blood sugar monitoring using sensors on the skin and directly connected insulin delivery systems have significantly facilitated diabetes treatment. Several studies have already shown that the quality of life as well as the complication and mortality rates after complete pancreas removal are comparable to the results after partial pancreas removal.

The two main risk factors for a fistula are soft pancreatic tissue and a narrow main duct in the pancreas. Both factors can only be assessed during the operation by the surgeons. If a high risk for the development of a fistula is identified during the operation, patients (who have been informed about the study and have given their consent) can be definitively included in the study. The patients will then be randomly assigned to the standard or intervention group.
It is important to know that surgeons always inform all their patients about the possibility of complete pancreas removal before such a major tumor operation. Furthermore, it has been scientifically proven that both operations are safe and suitable for the treatment of pancreatic cancer.

This study is dedicated to patients with certain, very aggressive tumors in the area of the head of the pancreas. We focus on so-called adenocarcinomas of the pancreas itself (commonly referred to as 'pancreatic cancer'), cancer of the lower bile duct, and cancer in the area of the opening of the bile duct into the duodenum (so-called papillary carcinomas). For all three types of cancer, both complete tumor removal and subsequent chemotherapy are very important. Only then can healing from these cancers be achieved.