Use of indocyanine green to reduce postoperative pancreatic fistula, the most common complication of cephalic duodenopancreatectomy: a unicentric quasi-experimental study

Abstract

Background: The pancreatic fistula is the most common complication after the cephalic pancreaticoduodenectomy. Despite numerous trials aimed at reducing its incidence, it still ranges between 3-45% of pancreatic operations, being the main determinant of serious postoperative morbidity and mortality and playing a major role in terms of hospital stay and economic impact. The exact pathophysiology of fistulas and why they appear is not yet known, but several studies have begun to suggest that fistulas may be related to hypoperfusion of the pancreatic remnant afer surgery with following failure of the pancreatico-enteric anastomosis. On the other hand, we know that indocyanine green is a well established tool to assess intraoperative tissue perfusion. ObjecPves: The aim of this study is to assess whether the use of indocyanine green significantly reduces the occurrence of pancreatic fistulas in patients who undergo duodenopancreatectomy at the Hospital de Girona Dr. Josep Trueta. Secondary objectives are to assess whether the use of indocyanine green modifies the extent of surgical resection of the pancreas during the duodenopancreatectomy, and if it reduces the hospital stay and the 30-day mortality. Design: It is a unicentric quasi-experimental study, aiming to compare the occurrence of pancreatic fistulas in patients who underwent the cephalic duodenopancreatectomy without indocyanine green and the patients who will undergo the surgery with indocyanine green. ParPcipants and methods: 132 participants will be enrolled using a consecutive sample, and a time of recruitment will be of 26 months. The data of the patients operated without indocyanine green will be extracted from an existing database of the hospital and the data of the patients who will undergo the surgery with indocyanine green will be collected during the perioperatory period and follow up. The results will be analyzed and compared by a statistician