Dataset Information

Assessment of graft perfusion and oxygenation for improved outcome in esophageal cancer surgery: Protocol for a single-center prospective observational study.

ABSTRACT: INTRODUCTION:The main cause of anastomotic leakage (AL) is tissue hypoxia, which results from impaired perfusion of the pedicle stomach graft after esophageal reconstruction. Clinical judgment is unreliable in determining graft perfusion. Therefore, an objective, validated, and reproducible method is urgently needed. Near infrared fluorescence perfusion imaging using indocyanine green (ICG) is an emerging and promising modality. This study's objectives are to evaluate the feasibility of quantification of ICG angiography (ICGA) to assess graft perfusion and to validate ICGA by comparison with hemodynamic parameters, blood and tissue expression of hypoxia-induced markers, and tissue mitochondrial respiration rates. And, second, to evaluate its ability to predict AL in patients after minimally invasive esophagectomy (MIE). METHODS:Patients (N?=?70) with resectable esophageal cancer will be recruited for standard MIE. ICGA will be performed after graft creation and thoracic pull-up. Dynamic digital images will be obtained starting after intravenous bolus administration of ICG. The resulting images will be subjected to curve analysis and to compartmental analysis based on the adiabatic approximation to tissue homogeneity kinetic model. The calculated perfusion parameters will be compared to intraoperative hemodynamic data to evaluate the effects of patient hemodynamics. To verify whether graft perfusion represents tissue oxygenation, ICGA perfusion parameters will be compared with systemic and serosa lactate from the stomach graft. In addition, perfusion parameters will be compared to tissue expression of hypoxia-related markers and mitochondrial chain respiratory rate. Finally, the ability of functional, histological, and cellular perfusion and oxygenation parameters to predict AL and postoperative morbidity in general will be evaluated using the appropriate univariate and multivariate statistical analyses. DISCUSSION:The results of this project may lead to a novel, reproducible, and minimally invasive method to objectively assess perioperative anastomotic perfusion during MIE, potentially reducing the incidence of AL and its associated severe morbidity and mortality. TRIAL REGISTRATION:Clinicaltrials.gov registration number is NCT03587532. The study was approved by the ethical committee of the Ghent University, Belgium (B670201836427).

SUBMITTER: Van Daele E

PROVIDER: S-EPMC6160056 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Assessment of graft perfusion and oxygenation for improved outcome in esophageal cancer surgery: Protocol for a single-center prospective observational study.

Van Daele Elke E Van Nieuwenhove Yves Y Ceelen Wim W Vanhove Christiaan C Braeckman Bart P BP Hoorens Anne A Van Limmen Jurgen J Varin Oswald O Van de Putte Dirk D Willaert Wouter W Pattyn Piet P

Medicine 20180901 38

<h4>Introduction</h4>The main cause of anastomotic leakage (AL) is tissue hypoxia, which results from impaired perfusion of the pedicle stomach graft after esophageal reconstruction. Clinical judgment is unreliable in determining graft perfusion. Therefore, an objective, validated, and reproducible method is urgently needed. Near infrared fluorescence perfusion imaging using indocyanine green (ICG) is an emerging and promising modality. This study's objectives are to evaluate the feasibility of ...[more]

PMID: 30235661

Similar Datasets

Project description:BackgroundThe occurrence of thyroid nodules and goiter increases with age. In general, surgery age is a predictor of perioperative morbidity. In thyroid surgery, there are different data on the role of age on morbidity. We investigated the influence of age on the outcome in thyroid surgery in a prospective single cohort study with a follow-up after 1 year.MethodsTotal thyroidectomy or hemithyroidectomy was performed in euthyroid benign thyroid goiters (n=152). The primary endpoint was surgery duration. The secondary endpoints were weight of resected tissue, body mass index (BMI), amount and type of perioperative and long-term complications, and quality of life (QoL) preoperatively and 1 year postoperatively.ResultsA significant three-way interactive relationship between age, surgery duration, and amount of resected tissue was found. An increase in any of these variables results in an increase in both other variables. The amount of perioperative complications was associated with resected tissue size. The QoL increases significantly after surgery by up to 10% and decreases significantly with age (mean QoL after surgery=84.9 of 100 for the youngest group and 75.7 of 100 for the oldest group). No long-term complications were recorded.ConclusionThe number of thyroid operations, especially of benign thyroid goiters, decreases annually in Germany. This can be explained by the fact that, on the one hand, the surgical indications are made more restrictive as conspicuous nodes are better clarified by improved technical aids. On the other hand, conservative measures (i.e. L-thyroxine and iodide administration) are used to achieve a size regimen of the goiter. Our results show that perioperative complications increase with patients' age and surgery duration. However, the more restrictive surgical decision also entails the risk that patients will have to be operated at an older age and possibly with a bigger goiter, which is associated with higher operative morbidity. Therefore, in addition to the possibility of conservative therapy of the symptomatic goiter, the affected patients should also be thoroughly informed about the option to perform elective early thyroid surgery with regard to improved postoperative QoL and to keep the overall stress at a minimum for elderly patients.

Project description:BackgroundEsophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined.MethodsThis prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach.DiscussionThis study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research.Trial registrationThis study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021, NCT05177393 .

Project description:Background/objectivesEndoscopic coronary artery bypass grafting (Endo-CABG) is a minimally invasive CABG procedure with retrograde arterial perfusion. The main objective of this study is to assess neurocognitive outcome after Endo-CABG.Methods/designIn this prospective observational cohort study, patients were categorised into: Endo-CABG (n = 60), a comparative Percutaneous Coronary Intervention (PCI) group (n = 60) and a healthy volunteer group (n = 60). A clinical neurological examination was performed both pre- and postoperatively, delirium was assessed postoperatively. A battery of 6 neurocognitive tests, Quality of life (QoL) and the level of depressive feelings were measured at baseline and after 3 months. Patient Satisfaction after Endo-CABG was assessed at 3-month follow-up. Primary endpoints were incidence of postoperative cognitive dysfunction (POCD), stroke and delirium after Endo-CABG. Secondary endpoints were QOL, patient satisfaction and the incidence of depressive feelings after Endo-CABG.ResultsIn total, 1 patient after Endo-CABG (1.72%) and 1 patient after PCI (1.67%) suffered from stroke during the 3-month follow-up. POCD in a patient is defined as a Reliable Change Index ≤-1.645 or Z-score ≤-1.645 in at least two tests, and was found in respectively 5 and 6 patients 3 months after Endo-CABG and PCI. Total incidence of POCD/stroke was not different (PCI: n= 7 [15.9%]; Endo-CABG: n= 6 [13.0%], p = 0.732). ICU delirium after Endo-CABG was found in 5 (8.6%) patients. QoL increased significantly three months after Endo-CABG and was comparable with QoL level after PCI and in the control group. Patient satisfaction after Endo-CABG and PCI was comparable. At follow-up, the level of depressive feelings was decreased in all groups.ConclusionsThe incidence of poor neurocognitive outcome, including stroke, POCD and postoperative ICU delirium until three months after Endo-CABG is low and comparable with PCI.Trial registrationRegistered on ClinicalTrials.gov (NCT02979782).

Project description:INTRODUCTION:Adverse neurocognitive outcomes are still an important cause of morbidity and mortality after cardiac surgery. The most common neurocognitive disorders after conventional cardiac surgery are postoperative cognitive dysfunction (POCD), stroke and delirium. Minimal invasive cardiac procedures have recently been introduced into practice. Endoscopic coronary artery bypass grafting (Endo-CABG) is a minimal invasive cardiac procedure based on the conventional CABG procedure. Neurocognitive outcome after minimal invasive cardiac surgery, including Endo-CABG, has never been studied. Therefore, the main objective of this study is to examine neurocognitive outcome after Endo-CABG. METHODS AND ANALYSIS:We will perform a prospective observational cohort study including 150 patients. Patients are categorised into three groups: (1) patients undergoing Endo-CABG, (2) patients undergoing a percutaneous coronary intervention and (3) a healthy volunteer group. All patients in the Endo-CABG group will be treated following a uniform, standardised protocol. To assess neurocognitive outcome after surgery, a battery of six neurocognitive tests will be administered at baseline and at 3-month follow-up. In the Endo-CABG group, a neurological examination will be performed at baseline and postoperatively and delirium will be scored at the intensive care unit. Quality of life (QOL), anxiety and depression will be assessed at baseline and at 3-month follow-up. Satisfaction with Endo-CABG will be assessed at 3-month follow-up. Primary endpoints are the incidence of POCD, stroke and delirium after Endo-CABG. Secondary endpoints are QOL after Endo-CABG, patient satisfaction with Endo-CABG and the incidence of anxiety and depression after Endo-CABG. ETHICS AND DISSEMINATION:The neurological outcome after minimal invasive coronary artery surgery study has received approval of the Jessa Hospital ethics board. It is estimated that the trial will be executed from December 2016 to January 2018, including enrolment and follow-up. Analysis of data, followed by publication of the results, is expected in 2018. TRIAL REGISTRATION NUMBER:NCT02979782.

Dataset Information

Assessment of graft perfusion and oxygenation for improved outcome in esophageal cancer surgery: Protocol for a single-center prospective observational study.

Publications

Assessment of graft perfusion and oxygenation for improved outcome in esophageal cancer surgery: Protocol for a single-center prospective observational study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets