German Clinical Trials Register

Acronym/abbreviation of the study

RECOPS

URL of the study

No Entry

Brief summary in lay language

Along with operations on the esophagus and rectum, operations on the pancreas are among the high-risk procedures in the gastrointestinal tract. Depending on the experience of the center, mortality can rise to over 10%. In order to reduce the rate of complications, several options for reconstruction of the gastrointestinal passage have been presented. One of them is the so-called reconstruction according to Child, which provides an anastomosis of the pancreas, bile ducts and duodenum in pylorus-preserving operations or stomach in the classical variant on a single loop of small intestine. Regardless of the different reconstruction techniques, leaks of the anastomosis of the small bowel loop and the residual pancreas represent the main risk of postoperative mortality and for the occurrence of postoperative complications. To decrease the rate of leakage, this trial investigates the benefit of an additional anastomosis between the efferent and the afferent loop of the anastomosis of the small bowel loop and the duodenum. This should facilitate the outflow of the afferent small intestine, to which the anastomosis of the pancreas is attached, and at the same time reduce the risk of backflow of food and digestive juices from the efferent look.

Brief summary in scientific language

The pylorus-preserving partial pancreatoduodenectomy according to Transverso-Longmire is one of the most complex and demanding operations for surgeons as well as for patients. Depending on the expertise of the center as well as the surgeon, the mortality rate increases from less than 5% in centers specializing in pancreatic surgery to more than 10%. Pancreatic fistulas represent a major risk factor for postoperative mortality. Depending on the severity of the clinically relevant pancreatic fistula, the mortality rate increases to 40%. Several reconstruction techniques have been developed to minimize the risk of postoperative complications. The most commonly used reconstruction technique is the Child reconstruction. Here, the pancreaticojejunostomy, the hepaticojejunostomy, and the duodenojejunostomy are attached to a single jejunal loop. In this randomized-controlled study, the benefit of an additional anastomosis between the afferent and efferent loop of the duodenojejunostomy - also called Braun's anastomosis - is to be explored. This is intended to facilitate the outflow of bile and pancreatic fluids from the afferent loop while reducing reflux from the efferent loop, thus relieving the pressure on the pancreaticojejunostomy. This should reduce not only the rate of pancreatic fistulae but also the rate of postoperative complications per se.