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.
- Klíčová slova
- ICG, Minimal invasive surgery, Pancreatic cancer, Pancreatic perfusion, Pancreatic surgery, Prospective study,
- 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
- pozorovací studie jako téma MeSH
- prospektivní studie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- Názvy látek
- indokyanová zeleň * 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
INTRODUCTION: Complete mesocolic excision (CME) ensures the removal of all sentinel and regional lymph nodes during colon cancer surgery. For right-sided hemicolectomy it is essential to dissect the wall of vena mesenterica superior, which increases the risk of injuring surrounding organs. So far, no randomized studies comparing long-term oncological results of standard right hemicolectomy and hemicolectomy with CME have been published. METHOD: 83 patients operated for colon carcinoma in 2014 and 2015 were included in this study, all of them undergoing right-sided hemicolectomy using laparotomy access. The standard procedure was done in 63 cases and hemicolectomy with CME was done in 20 cases. We compared the incidence of complications, and the characteristics and descriptions of obtained specimens evaluated by a pathologist for both groups. RESULTS: The operation times of right-sided hemicolectomies with CME was longer by 20 minutes on average. The incidence of postoperative complications was similar in both groups. Pancreatic fistula in the group of patients undergoing right-sided hemicolectomy with CME was an unusual complication; the fistula was healed through conservative treatment. Comparing the resecate parameters, we found no significant differences in the lengths of the resected terminal ileum. But the length of the resected colon was significantly longer for the CME technique (median 42 cm versus 22 cm). The incidence of lymph node metastases was similar in both groups. However, the total number of removed lymph nodes in the group with CME was significantly higher (median 23). CONCLUSION: Right-sided hemicolectomy with complete mesocolic excision offers the removal of more lymph nodes than the standard technique. The central vascular ligation technique elongates the operation time and may be associated with more intraoperative injuries. Introduction of the concept of complete mesocolic excision is derived from an effort to standardize the surgical technique for colon cancer resection.Key words: right-sided hemicolectomy complete mesocolic excision colon cancer lymphadenectomy.
- MeSH
- délka operace MeSH
- incidence MeSH
- karcinom patologie chirurgie MeSH
- kolektomie metody MeSH
- lidé MeSH
- ligace MeSH
- lymfadenektomie metody MeSH
- lymfatické metastázy MeSH
- lymfatické uzliny patologie chirurgie MeSH
- mezokolon chirurgie MeSH
- nádory tračníku patologie chirurgie MeSH
- pankreatická píštěl epidemiologie MeSH
- pooperační komplikace epidemiologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH