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Article: Endoscopic Ultrasound (EUS) Guided Elastography.

Iglesias-Garcia, Julio / de la Iglesia-Garcia, Daniel / Lariño-Noia, Jose / Dominguez-Muñoz, Juan Enrique

2023 Volume 13, Issue 10

Abstract: Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed to improve and overcome certain limitations related to EUS-guided tissue acquisition. Among these new ... ...

Abstract	Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed to improve and overcome certain limitations related to EUS-guided tissue acquisition. Among these new methods, EUS-guided elastography, which is a real-time method for the evaluation of tissue stiffness, has arisen as one of the most widely recognized and available. At present, there are available two different systems to perform an elastographic evaluation: strain elastography and shear wave elastography. Strain elastography is based on the knowledge that certain diseases lead to a change in tissue hardness while shear wave elastography monitored shear-wave propagation and measures its velocity. EUS-guided elastography has shown in several studies high accuracy in differentiating benign from malignant lesions from many different locations, mostly in the pancreas and lymph nodes. Therefore, nowadays, there are well-established indications for this technology, mainly for supporting the management of pancreatic diseases (diagnosis of chronic pancreatitis and differential diagnosis of solid pancreatic tumors) and characterization of different diseases. However, there are more data on new potential indications for the near future. In this review, we will present the theoretical bases of this technology and we will discuss the scientific evidence to support its use.
Language	English
Publishing date	2023-05-10
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics13101686
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Article ; Online: Quality of Tissue Samples Obtained by Endoscopic Ultrasound-Guided Liver Biopsy: A Randomized, Controlled Clinical Trial.

Lariño-Noia, José / Fernández-Castroagudín, Javier / de la Iglesia-García, Daniel / Lázare, Héctor / Nieto, Laura / Porto, Sol / Vallejo-Senra, Nicolau / Molina, Esther / San Bruno, Alba / Martínez-Seara, Xurxo / Iglesias-García, Julio / García-Acuña, Silvia / Domínguez-Muñoz, J Enrique

The American journal of gastroenterology

2023 Volume 118, Issue 10, Page(s) 1821–1828

Abstract: Introduction: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at ... ...

Abstract	Introduction: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at comparing the adequacy of samples obtained by EUS-LB with percutaneous LB. Methods: A single-center, randomized, controlled clinical trial was designed. Patients undergoing LB were randomly assigned to EUS-LB or percutaneous LB groups. EUS-LB was performed with a 19-gauge Franseen core needle through a transduodenal and transgastric route. Percutaneous LB was performed with a 16-gauge Tru-Cut needle. The main outcome was the percentage of adequate samples obtained. Secondary outcomes were the percentage of accurate histologic diagnosis, number of complete portal tracts (CPT), total and longest specimen length (TSL and LSL), sample fragmentation, adverse events, and patients' satisfaction. An adequate specimen was defined as TSL ≥20 mm and including ≥11 CPT. Results: Ninety patients were randomized (44 to EUS-LB and 46 to percutaneous LB) and included in the analysis. The percentage of adequate tissue samples was 32.6% and 70.4% for percutaneous LB and EUS-LB, respectively ( P < 0.001). A final histologic diagnosis was provided in all cases but one. TSL was longer after EUS-LB (23.5 vs 17.5 mm, P = 0.01), whereas the number of CPT was similar in both groups. Sample fragmentation occurred more often after EUS-LB ( P < 0.001). No differences in adverse events were found. Satisfaction reported with both procedures was high. Discussion: EUS-LB is safe and accurate and may be considered an alternative to percutaneous LB for the evaluation of parenchymal liver diseases.
MeSH term(s)	Humans ; Liver Diseases/diagnosis ; Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods ; Prospective Studies ; Image-Guided Biopsy
Language	English
Publishing date	2023-06-19
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	390122-1
ISSN	1572-0241 ; 0002-9270
ISSN (online)	1572-0241
ISSN	0002-9270
DOI	10.14309/ajg.0000000000002375
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Article ; Online: Pancreatic Elastography Predicts Endoscopic Secretin-Pancreatic Function Test Result in Patients With Early Changes of Chronic Pancreatitis: A Prospective, Cross-Sectional, Observational Study.

Iglesias-Garcia, Julio / Lariño-Noia, Jose / Nieto Bsn, Laura / Alvarez-Castro, Ana / Lojo, Santiago / Leal, Saul / de la Iglesia-Garcia, Daniel / Domínguez-Muñoz, J Enrique

The American journal of gastroenterology

2022 Volume 117, Issue 8, Page(s) 1264–1268

Abstract: Introduction: The endoscopic pancreatic function test (ePFT) has been proposed for the evaluation of patients with suspected early chronic pancreatitis (CP) in the appropriate clinical context, but the cost and duration of the test limit its clinical ... ...

Abstract	Introduction: The endoscopic pancreatic function test (ePFT) has been proposed for the evaluation of patients with suspected early chronic pancreatitis (CP) in the appropriate clinical context, but the cost and duration of the test limit its clinical applicability. Pancreatic secretion decreases as pancreatic fibrosis develops in CP. Pancreatic fibrosis can be quantified by endoscopic ultrasound-elastography (EUS-E). We aim at evaluating whether EUS-E correlates with and could replace ePFT for the evaluation of patients with suspected CP. Methods: A prospective, cross-sectional, and observational study of patients with clinical suspicion of CP and inconclusive EUS findings was conducted. EUS-E and ePFT were performed. Diagnosis of CP was supported if the ePFT result (bicarbonate peak) was abnormally low (<80 mEq/L). Correlation between EUS-E (strain ratio [SR]) and ePFT results was analyzed by linear regression. Diagnostic accuracy of EUS-E for CP was calculated using ePFT as a reference method. Results: Sixty-one patients were included and analyzed. The mean peak bicarbonate concentration at the ePFT was 63.8 ± 23.6 mEq/L, and it was abnormally low in 50 patients (82.0%). The mean SR was 3.85 ± 1.24. Correlation between SR and bicarbonate secretion was highly significant ( r = 0.715, P < 0.0001). Diagnostic accuracy of EUS-E for CP was 93.4%. Discussion: The degree of pancreatic fibrosis as evaluated by EUS-E correlates significantly with the secretin-stimulated pancreatic secretion of bicarbonate in patients with clinical suspicion of CP and inconclusive EUS findings of the disease. EUS-E could replace ePFT for the evaluation of these patients in clinical practice.
MeSH term(s)	Bicarbonates ; Cross-Sectional Studies ; Elasticity Imaging Techniques ; Endosonography ; Fibrosis ; Humans ; Pancreatic Function Tests/methods ; Pancreatitis, Chronic/diagnostic imaging ; Prospective Studies ; Secretin
Chemical Substances	Bicarbonates ; Secretin (1393-25-5)
Language	English
Publishing date	2022-06-03
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	390122-1
ISSN	1572-0241 ; 0002-9270
ISSN (online)	1572-0241
ISSN	0002-9270
DOI	10.14309/ajg.0000000000001846
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Article ; Online: Differential diagnosis of solid pancreatic masses.

Iglesias-Garcia, Julio / de la Iglesia-Garcia, Daniel / Olmos-Martinez, José M / Lariño-Noia, José / Dominguez-Muñoz, J Enrique

Minerva gastroenterologica e dietologica

2020 Volume 66, Issue 1, Page(s) 70–81

Abstract: Solid pancreatic lesions include mainly adenocarcinoma, neuroendocrine tumors pancreatic cystic neoplasms with solid component, solid pseudopapillary tumor, pancreatoblastoma, pancreatic lymphoma, and pancreatic metastasis. The most frequent pancreatic ... ...

Abstract	Solid pancreatic lesions include mainly adenocarcinoma, neuroendocrine tumors pancreatic cystic neoplasms with solid component, solid pseudopapillary tumor, pancreatoblastoma, pancreatic lymphoma, and pancreatic metastasis. The most frequent pancreatic lesion is the adenocarcinoma, representing between 70% and 95% of all solid pancreatic neoplasm. The diagnosis of these lesions can be a challenge and currently, there are different imaging techniques such as CT scan, EUS and MRI with high sensitivity and specificity. The most widely used technique for the initial evaluation is the CT scan with a sensitivity between 76% and 92% for the diagnosis of pancreatic cancer. The EUS has a sensitivity for the detection of pancreatic lesions of around 98% and is accepted to be the most sensitive technique for the detection of small pancreatic tumors (<2 cm). The MRI, with a very high soft-tissue contrast resolution, provides an accuracy in the detection and staging of adenocarcinoma of 90-100%. A multimodality approach is usually necessary in patients with clinical suspicion of pancreatic lesion. The EUS is required for the local evaluation of the relation of the lesion with vessels and for tissue acquisition and the CT scan and/or MRI is usually required for the local and distance staging in case of pancreatic cancer. The purpose of this review is to provide an overview of solid pancreatic lesions and the role of the different imaging techniques in their evaluation.
MeSH term(s)	Diagnosis, Differential ; Diagnostic Imaging/methods ; Humans ; Pancreatic Neoplasms/diagnostic imaging
Language	English
Publishing date	2020-01-28
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	1077354-x
ISSN	1827-1642 ; 1121-421X ; 0026-4776
ISSN (online)	1827-1642
ISSN	1121-421X ; 0026-4776
DOI	10.23736/S1121-421X.20.02646-X
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Article ; Online: Endoscopic Pancreatic Drainage Improves Exocrine Pancreatic Function in Patients With Unresectable Pancreatic Cancer: A Double-Blind, Prospective, Randomized, Single-Center, Interventional Study.

Domínguez-Muñoz, J Enrique / de la Iglesia-García, Daniel / Nieto-García, Laura / Álvarez-Castro, Ana / San Bruno-Ruz, Alba / Monteserín-Ron, Luz / López-Díaz, Javier / Iglesias-García, Julio

Pancreas

2021 Volume 50, Issue 5, Page(s) 679–684

Abstract: Objectives: Exocrine pancreatic insufficiency is a frequent and clinically relevant complication of pancreatic cancer probably secondary to pancreatic duct obstruction. We aimed at evaluating the impact of endoscopic pancreatic drainage on pancreatic ... ...

Abstract	Objectives: Exocrine pancreatic insufficiency is a frequent and clinically relevant complication of pancreatic cancer probably secondary to pancreatic duct obstruction. We aimed at evaluating the impact of endoscopic pancreatic drainage on pancreatic function in patients with unresectable pancreatic cancer. Methods: A double-blind, prospective, randomized, single-center, interventional study was designed. Patients undergoing endoscopic retrograde cholangiopancreatography for jaundice secondary to unresectable pancreatic cancer were randomized to biliary drainage (group A) or biliopancreatic drainage (group B). Pancreatic function was evaluated by 13C-mixed triglyceride breath test before and 2 weeks after endoscopic retrograde cholangiopancreatography. Breath test result is expressed as 13C-cumulative recovery rate. Abdominal symptoms and nutritional markers were evaluated as secondary outcomes. Results: Twenty patients were included. Sixteen patients had exocrine pancreatic insufficiency, and 13 completed the study (7 in group A and 6 in group B). The median absolute improvement of 13C-cumulative recovery rate was of 23.75% (interquartile range, 9.62-31.74) after biliopancreatic drainage compared with -1.92% (interquartile range, -4.17 to 13.92) after biliary drainage (P = 0.015). Nutritional markers improved after biliopancreatic drainage, but not after biliary drainage. Conclusions: Biliopancreatic and not biliary endoscopic drainage is associated with a significant improvement of exocrine pancreatic function in patients with unresectable pancreatic cancer.
MeSH term(s)	Aged ; Aged, 80 and over ; Breath Tests ; Cholangiopancreatography, Endoscopic Retrograde/adverse effects ; Double-Blind Method ; Drainage/adverse effects ; Exocrine Pancreatic Insufficiency/diagnosis ; Exocrine Pancreatic Insufficiency/physiopathology ; Exocrine Pancreatic Insufficiency/therapy ; Female ; Humans ; Male ; Middle Aged ; Pancreas, Exocrine/pathology ; Pancreas, Exocrine/physiopathology ; Pancreatic Function Tests ; Pancreatic Neoplasms/diagnosis ; Pancreatic Neoplasms/physiopathology ; Pancreatic Neoplasms/therapy ; Prospective Studies ; Recovery of Function ; Spain ; Time Factors ; Treatment Outcome
Language	English
Publishing date	2021-05-17
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	632831-3
ISSN	1536-4828 ; 0885-3177
ISSN (online)	1536-4828
ISSN	0885-3177
DOI	10.1097/MPA.0000000000001817
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Article ; Online: Rapid diagnosis of mucinous cystic pancreatic lesions by on-site cyst fluid glucometry.

Noia, José Lariño / Mejuto, Rafael / Oria, Inés / De la Iglesia-García, Daniel / Villaverde, Augusto / Voces, Alba / Pizzala, Juan / Iglesias-García, Julio / Urgiles, Dalila / Marcolongo, Mariano / Mazza, Oscar / Dominguez-Muñoz, Enrique

Surgical endoscopy

2021 Volume 36, Issue 4, Page(s) 2473–2479

Abstract: Introduction: Available intracystic biomarkers show a limited accuracy for characterizing cystic pancreatic lesions (CPL). Glucose is an attractive alternative due to its availability, low cost and the possibility of on-site quantification by glucometry. ...

Abstract	Introduction: Available intracystic biomarkers show a limited accuracy for characterizing cystic pancreatic lesions (CPL). Glucose is an attractive alternative due to its availability, low cost and the possibility of on-site quantification by glucometry. Aim: To evaluate the diagnostic accuracy of on-site glucometry from samples obtained by EUS-FNA in the differential diagnosis between mucinous from non-mucinous CPL. Methods: Retrospective, multicentre, cross-sectional study of patients who underwent EUS-FNA of a CPL. A derivation and a validation cohorts were evaluated. Intracystic glucose was quantified by on-site glucometry and colorimetry in the lab. Final diagnosis was based on surgical specimens or global evaluation of clinical and imaging data, cytology and intracystic CEA. Diagnostic accuracy was based on Receiver Operating Curve (ROC) curve analysis. Intraclass correlation coefficient (ICC) between on-site and lab glucose levels was calculated. Results: Seventy two patients were finally analysed (40 in the derivation cohort and 32 in the validation cohort). Intracystic glucose levels by on-site glucometry was 12.3 ± 28.2 mg/dl for mucinous CPL and 103.3 ± 58.2 mg/dl for non-mucinous CPL, p < 0.001. For an optimal cut-off point of 73 mg/dl, on-site glucose had a sensitivity, specificity, and positive and negative predictive value for the diagnosis of mucinous CPL of 0.89, 0.90, 0.94, 0.82 respectively in the derivation cohort, and 1.0, 0.71, 0.91, 1.0 respectively in the validation cohort. Correlation of on-site and lab glucose quantification was very high (ICC = 0.98). Conclusion: On-site glucometry is a feasible, accurate and reproducible method for the characterization of CPL after EUS-FNA. It shows an excellent correlation with laboratory glucose values. Registration number: 2019/612.
MeSH term(s)	Carcinoembryonic Antigen ; Cross-Sectional Studies ; Cyst Fluid ; Glucose ; Humans ; Pancreatic Cyst/diagnostic imaging ; Pancreatic Neoplasms/diagnosis ; Pancreatic Neoplasms/pathology ; Retrospective Studies
Chemical Substances	Carcinoembryonic Antigen ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2021-05-14
Publishing country	Germany
Document type	Journal Article ; Multicenter Study
ZDB-ID	639039-0
ISSN	1432-2218 ; 0930-2794
ISSN (online)	1432-2218
ISSN	0930-2794
DOI	10.1007/s00464-021-08532-9
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Article ; Online: Emergent endoscopic ultrasound-guided cholecystoduodenostomy does not prevent R0 resection in a pancreaticoduodenectomy for pancreatic cancer.

Lariño-Noia, José / Fernández, Rafael Mejuto / Novo, Manuel Paz / de la Iglesia García, Daniel / Iglesias-García, Julio / Castiñeira, Adriano Quiroga / Pérez, Evaristo Varo / Dominguez-Muñoz, Juan Enrique

Clinical journal of gastroenterology

2021 Volume 15, Issue 1, Page(s) 263–267

Abstract: Endoscopic ultrasound-guided biliary drainage, mainly choledochoduodenostomy, is commonly used as rescue therapy after Endoscopic Retrograde Cholangiopancreatography (ERCP) in malignant distal biliary obstruction due to un-resectable pancreatic cancer. ... ...

Abstract	Endoscopic ultrasound-guided biliary drainage, mainly choledochoduodenostomy, is commonly used as rescue therapy after Endoscopic Retrograde Cholangiopancreatography (ERCP) in malignant distal biliary obstruction due to un-resectable pancreatic cancer. An alternative when the cystic duct is patent and choledochoduodenostomy is not feasible is performing an Endoscopic Ultrasound-gallbladder drainage. The advent of the Lumen Apposing Metal Stents (LAMS) has shortened and simplified this procedure. However, many concerns exist about the performance of these procedures with metal stents preoperatively in resectable tumors. The evidence about Endoscopic Ultrasound-gallbladder drainage before surgery of pancreatic cancer is scarce. An emergent Endoscopic Ultrasound (EUS)-gallbladder drainage (cholecysto-duodenostomy) was performed due to acute cholangitis in the setting of a resectable pancreatic tumor. Surgery after neoadjuvant therapy was done three months later. A complete resection of tumor was feasible. EUS-guided gallbladder drainage using LAMS does not preclude performing a complete resection of a pancreatic head tumor.
MeSH term(s)	Cholangiopancreatography, Endoscopic Retrograde/methods ; Cholestasis/surgery ; Drainage/methods ; Endosonography/methods ; Gallbladder/surgery ; Humans ; Pancreatic Neoplasms/diagnostic imaging ; Pancreatic Neoplasms/surgery ; Pancreaticoduodenectomy ; Stents ; Treatment Outcome ; Ultrasonography, Interventional/methods
Language	English
Publishing date	2021-10-25
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2429411-1
ISSN	1865-7265 ; 1865-7257
ISSN (online)	1865-7265
ISSN	1865-7257
DOI	10.1007/s12328-021-01540-1
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Article: EUS-FNA in cystic pancreatic lesions: Where are we now and where are we headed in the future?

Lariño-Noia, Jose / Iglesias-Garcia, Julio / de la Iglesia-Garcia, Daniel / Dominguez-Muñoz, J Enrique

Endoscopic ultrasound

2018 Volume 7, Issue 2, Page(s) 102–109

Abstract: EUS-FNA is often performed in the evaluation of Cystic Pancreatic Lesions (CPL) for a better preoperative characterization. The objective is to identify premalignant lesions as Mucinous Cystic Neoplasms, and/or a malignant transformation of them ( ... ...

Abstract	EUS-FNA is often performed in the evaluation of Cystic Pancreatic Lesions (CPL) for a better preoperative characterization. The objective is to identify premalignant lesions as Mucinous Cystic Neoplasms, and/or a malignant transformation of them (adenocarcinoma). The role of cytological evaluation in this setting is discouraging and intracystic markers analysis, mainly CEA, lacks of a good specificity for the detection of mucinous neoplasms. New devices and approaches have emerged to overcome these problems as the cytology brush (Echobrush), the small mini-biopsy foceps, the cystoscopy and the needle Confocal LASER Endomicroscopy (nCLE), showing in some studies good rates of accuracy for distinguishing among mucinosus and non-mucinous neoplasms. However, intracystic molecular marker analysis, by identifying mutations in DNA of particular genes as KRAS,GNAS,VHL, CDKN2A and others constitute the most relevant advancement of last years and will contribute in the next future to a better management of CPL. The role of EUS-FNA according to international guidelines is still controversial. While 2012 Fukuoka guidelines are restrictive in their indications AGA 2015 guidelines support it when high risk features are present, enhancing the role of the cytological evaluation in taking decisions.
Language	English
Publishing date	2018-04-18
Publishing country	China
Document type	Journal Article ; Review
ZDB-ID	2998317-4
ISSN	2226-7190 ; 2303-9027
ISSN (online)	2226-7190
ISSN	2303-9027
DOI	10.4103/eus.eus_93_17
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Article ; Online: Endoscopic ultrasound-based multimodal evaluation of the pancreas in patients with suspected early chronic pancreatitis.

Domínguez-Muñoz, J Enrique / Lariño-Noia, Jose / Alvarez-Castro, Ana / Nieto, Laura / Lojo, Santiago / Leal, Saul / de la Iglesia-Garcia, Daniel / Iglesias-Garcia, Julio

United European gastroenterology journal

2020 Volume 8, Issue 7, Page(s) 790–797

Abstract: Background: Diagnosis of early chronic pancreatitis is a clinical challenge and hindered by the lack of a gold standard. Endoscopic ultrasound (EUS) and the endoscopic pancreatic function test (ePFT) are the most sensitive morphological and functional ... ...

Abstract	Background: Diagnosis of early chronic pancreatitis is a clinical challenge and hindered by the lack of a gold standard. Endoscopic ultrasound (EUS) and the endoscopic pancreatic function test (ePFT) are the most sensitive morphological and functional methods in this setting. EUS-elastography allows for the quantification (strain ratio) of pancreatic fibrosis, and the dynamic evaluation of the main pancreatic duct compliance provides additional information. We developed a multimodal EUS-based approach for the evaluation of the pancreas by integrating these four methods in a single procedure. Objective: We aim to describe morphological and functional pancreatic abnormalities in patients with clinical suspicion of chronic pancreatitis and inconclusive EUS findings by using the multimodal EUS-based approach. Methods: This was a prospective, cross-sectional, observational study of patients with clinically suspected chronic pancreatitis and indeterminate EUS criteria of the disease. EUS criteria of chronic pancreatitis, quantitative pancreatic elastography, ePFT and compliance of the main pancreatic duct were evaluated in a single procedure. Results: In total, 53 patients with 3-4 EUS criteria of chronic pancreatitis were included (mean age 39.7 years, 29 male). Strain ratio was abnormally high in all patients. Peak bicarbonate concentration was decreased in 43 patients (81.1%) and the main pancreatic duct compliance was reduced in 41 patients (77.3%). Some 34 patients (64.1%) had abnormal results at EUS, elastography, ePFT and compliance of the main pancreatic duct. Conclusions: A multimodal EUS-based test for the morphological and functional evaluation of the pancreas is presented, which allows detecting mild pancreatic abnormalities in patients with suspected early chronic pancreatitis. The presence of abnormal morphological and functional evaluation of the pancreas could support the clinical suspicion of early chronic pancreatitis in the appropriate clinical setting.
MeSH term(s)	Adolescent ; Adult ; Aged ; Bicarbonates/analysis ; Bicarbonates/metabolism ; Cross-Sectional Studies ; Early Diagnosis ; Elasticity Imaging Techniques/methods ; Endosonography/methods ; Feasibility Studies ; Female ; Humans ; Injections, Intravenous ; Male ; Middle Aged ; Multimodal Imaging/methods ; Pancreatic Ducts/diagnostic imaging ; Pancreatic Ducts/metabolism ; Pancreatic Function Tests/methods ; Pancreatitis, Chronic/diagnosis ; Prospective Studies ; Secretin/administration & dosage ; Young Adult
Chemical Substances	Bicarbonates ; Secretin (1393-25-5)
Language	English
Publishing date	2020-06-23
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2728585-6
ISSN	2050-6414 ; 2050-6406
ISSN (online)	2050-6414
ISSN	2050-6406
DOI	10.1177/2050640620936810
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Article: Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer.

Kiriukova, Mariia / de la Iglesia Garcia, Daniel / Panic, Nikola / Bozhychko, Maryana / Avci, Bartu / Maisonneuve, Patrick / de-Madaria, Enrique / Capurso, Gabriele / Sandru, Vasile

Frontiers in medicine

2020 Volume 7, Page(s) 495

Abstract: Background:: Main outcome: adherence to planned chemotherapy in the first 12 weeks following the diagnosis, according to patients' baseline nutritional status and quantified and reported as "percent of standard chemotherapy dose delivered.": ... ...

Abstract	Background: Main outcome: adherence to planned chemotherapy in the first 12 weeks following the diagnosis, according to patients' baseline nutritional status and quantified and reported as "percent of standard chemotherapy dose delivered." Secondary outcomes: rate of chemotherapy-related toxicity, progression-free survival, survival at 6 months, overall survival, quality of life, and the number of hospitalizations. Analysis: chemotherapy dosing over the first 12 weeks of therapy (i.e., percent of chemotherapy received in the first 12 weeks, as defined above) will be compared between well-nourished and malnourished patients. Sample size: based on an expected percentage of chemotherapy delivered of 70% in well-nourished patients, with a type I error of 0.05 and a type II error of 0.20, a sample size of 93 patients per group will be required in case of a percentage difference of chemotherapy delivered of 20% between well-nourished and malnourished patients, 163 patients per group in case of a difference of 15% between the groups, and 356 patients per group in case of a 10% difference. Centers from Russia, Romania, Turkey, Spain, Serbia, and Italy will participate in the study upon Local Ethics Committee approval.
Language	English
Publishing date	2020-09-03
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2020.00495
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