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Pancreaticoduodenectomy clinical trials

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NCT ID: NCT06119880 Recruiting - Clinical trials for Pancreaticoduodenectomy

The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring: 1. The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy; 2. The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy; 3. The personalized full process nutrition management strategies based on risk factor stratification.

NCT ID: NCT05820997 Recruiting - Clinical trials for Pancreaticoduodenectomy

Paravertebral Block vs no Block in Open Pancreaticoduodenectomy

Start date: April 24, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.

NCT ID: NCT05523713 Recruiting - Hepatectomy Clinical Trials

Development and Validation of a Predictive Score for Surgical Site Infections

SPRED
Start date: October 6, 2022
Phase: Phase 3
Study type: Interventional

More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis. Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University). The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

NCT ID: NCT05475275 Recruiting - Clinical trials for Pancreaticoduodenectomy

Different Pancreaticojejunostomy After Pancreaticoduodenectomy

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

NCT ID: NCT05042882 Recruiting - Malnutrition Clinical Trials

Enteral vs. Oral Nutrition After Pancreatoduodenectomy

NUTRIWHI
Start date: December 12, 2021
Phase: N/A
Study type: Interventional

Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition. The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.

NCT ID: NCT04798560 Recruiting - Pancreatic Fistula Clinical Trials

Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy

Start date: October 10, 2018
Phase:
Study type: Observational [Patient Registry]

Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.

NCT ID: NCT04559269 Recruiting - Hepatectomy Clinical Trials

Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Start date: October 1, 2019
Phase:
Study type: Observational

During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

NCT ID: NCT04418739 Recruiting - Pancreatic Cancer Clinical Trials

Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Start date: January 27, 2020
Phase: Phase 2
Study type: Interventional

Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

NCT ID: NCT04342923 Recruiting - Clinical trials for Pancreaticoduodenectomy

Early POstoperative BIomarkers in PancreatoDuodenectomy: a Spanish Nationwide Study

EPOBIPD
Start date: March 1, 2021
Phase:
Study type: Observational

AIMS: To recruit a large nationwide Spanish series in order to register PF rate and other common morbidity after PD, and to perform external validation of the aforementioned score, as well as to analyze other postoperative blood parameters and biomarkers associated with complications. METHODS: Observational prospective and multicentric cohort study to perform external validation of the above-mentioned score. All Spanish centers/units performing PD are invited to include participants. Patients will be consecutively recruited during an 8-10 months period, regardless of their annual volume of pancreatic surgery. Study variables will be hemogram parameters on POD1 and POD2 (specifically lymphocytes), other parameters and biomarkers (RCP, lactate, procalcitonin, amylase, lipase, albumin) and the common variables concerning PD studies. LIMITATIONS: Heterogeneity in perioperative management and in blood analysis measuring since this is a multicenter study. Possibility of underestimating the PF rate in patients without surgical drainage. Finally, the cases of mini-invasive approach or pancreatogastrostomy will receive a specific subgroup analysis since the score was designed on a series of open PD and pancreatojejunostomy.

NCT ID: NCT04171440 Recruiting - Clinical trials for Pancreaticoduodenectomy

Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

Start date: February 18, 2020
Phase: N/A
Study type: Interventional

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.