RECOPS

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.

{ "short_title": "RECOPS", "data_mode": "900", "data_mode_number": "000002418", "official_title": "Effekt einer zus\u00e4tzlichen Braun-Fu\u00dfpunkt-Anastomose bei Patienten nach Pankreaskopfresektion", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Marius Distler", "description_laie_de": "Operationen an der Bauchspeicheldr\u00fcse geh\u00f6ren neben Operationen an Speiser\u00f6hre und Enddarm zu den Hochrisikoeingriffen im Magen-Darm-Trakt. Um die Rate an Komplikationen zu reduzieren, gibt es mehrere M\u00f6glichkeiten zur Rekonstruktion der Magen-Darm-Passage. Eine davon ist die so genannte Rekonstruktion nach Child, die eine Nahtverbindung von Bauchspeicheldr\u00fcse, Galleng\u00e4ngen und Duodenum bei pyloruserhaltenden Operationen vorsieht. Unabh\u00e4ngig von unterschiedlichen Rekonstruktionstechniken, stellen Undichtigkeiten an der Nahtverbindung zwischen D\u00fcnndarmschlinge und Restbauchspeicheldr\u00fcse das Hauptrisiko f\u00fcr postoperative Komplikationen dar. Um dies zu minimieren, untersucht diese Studie den Nutzen einer zus\u00e4tzlichen Nahtverbindung zwischen zwei D\u00fcnndarmschlingen. Diese wird zwischen der zu- und abf\u00fchrenden Schlinge des Nahtverbindung zwischen D\u00fcnndarm und Zw\u00f6lffingerdarm angelegt. Hierdurch soll der Abfluss \u00fcber den zuf\u00fchrenden D\u00fcnndarm, an welcher die Nahtverbindung der Bauchspeicheldr\u00fcse h\u00e4ngt, erleichtert und gleichzeitig das Risiko auf einen R\u00fcckfluss von Nahrungs- und Verdauungss\u00e4ften aus der efferenten Schlinge reduziert werden.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "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.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 2, "sub_cat_id": 4 }

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