BACKGROUND: Pancreaticoduodenectomy is associated with an incidence of postoperative complications of approximately 41%. One of the most severe complications is a postoperative pancreatic fistula. The exact cause of postoperative fistula development is still unknown, but it appears to be multifactorial. Proper perfusion of pancreatic remnant is essential for the healing of pancreaticojejunostomy. To date, there is no method to reliably evaluate the vascular supply of the remnant. One of the methods for the assessment of organ perfusion is the indocyanine green fluorescence. This study aims to determine if indocyanine green fluorescence is a reliable method to measure the perfusion of the post-resection pancreatic remnant. The secondary outcome is to determine if intraoperative evaluation of the vascular supply of the post-resection remnant may predict the increased risk of postoperative pancreatic fistula development. METHODS: This study is designed as a prospective, observational study. All consecutive patients undergoing open or robotic pancreaticoduodenectomies at our department during the 1st May 2024-31st December 2026 period will be enrolled. The exclusion criteria are an allergy to indocyanine green and refusal by the patient. The adequacy of the vascular supply of the post-resection pancreatic remnant will be intraoperatively evaluated using a fluorescence detector. Patients will be divided into two groups: Those with high risk of pancreatic fistula development and those with low risk. The incidence of pancreatic fistulas in both groups is to be compared. Postoperative data including morbidity, mortality, hospital stay, intensive care unit stay and postoperative fistula development will be collected. DISCUSSION: If an intraoperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green is proven to be a suitable method to estimate the increased risk of the pancreatic fistula, the list of the existing known risk factors could be expanded. In the most high-risk patients the modification of the surgical procedure could be considered. TRIAL REGISTRATION: Number: NCT06198400 ClinicalTrials.Gov. Date 08.01.2024.

• MeSH
• fluorescence MeSH
• indokyanová zeleň * MeSH
• lidé MeSH
• pankreas krevní zásobení   chirurgie   MeSH
• pankreatická píštěl * etiologie   epidemiologie   MeSH
• pankreatoduodenektomie * škodlivé účinky   metody   MeSH
• pooperační komplikace * etiologie   diagnóza   MeSH
• prospektivní studie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• protokol klinické studie MeSH

BACKGROUND: This dual-center, randomized controlled trial aimed to compare 2 types of intra-abdominal drains after pancreatic resection and their effect on the development of pancreatic fistulae and postoperative complications. METHODS: Patients undergoing pancreatic resection were randomized to receive either a closed-suction drain or a closed, passive gravity drain. The primary endpoint was the rate of postoperative pancreatic fistula. A secondary endpoint was postoperative morbidity during follow-up of 3 months. The planned sample size was 223 patients. RESULTS: A total of 294 patients were assessed for eligibility, 223 of whom were randomly allocated. One patient was lost during follow-up, and 111 patients in each group were analyzed. The rate of postoperative pancreatic fistula (closed-suction 43.2%, passive 36.9%, P = .47) and overall morbidity (closed-suction 51.4%, passive 40.5%, P = .43) were not different between the groups. We did not find any differences between the groups in reoperation rate (P = .45), readmission rate (P = .27), hospital stay (P = .68), or postoperative hemorrhage (P = .11). We found a significantly lesser amount of drain fluid in the passive gravity drains between the second and fifth postoperative days and also on the day of drain removal compared with closed-suction drains. CONCLUSION: The type of drain (passive versus closed suction) had no influence on the rate of postoperative pancreatic fistulae. The closed-suction drains did not increase the rate of postoperative complications. We found that the passive gravity drains are more at risk for obstruction, whereas the closed-suction drains kept their patency for greater duration.

• MeSH
• časové faktory MeSH
• délka pobytu statistika a číselné údaje   MeSH
• drenáž metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory slinivky břišní chirurgie   MeSH
• následné studie MeSH
• odsávání metody   MeSH
• pankreas chirurgie   MeSH
• pankreatektomie škodlivé účinky   MeSH
• pankreatická píštěl epidemiologie   etiologie   prevence a kontrola   MeSH
• pooperační komplikace epidemiologie   etiologie   prevence a kontrola   MeSH
• reoperace statistika a číselné údaje   MeSH
• senioři MeSH
• výsledek terapie MeSH
• znovupřijetí pacienta statistika a číselné údaje   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH