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2. Outcome of patients with peritoneal metastasis from ovarian cancer treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Author

Foslund Ingrid Terese, von Magius Sahra Aisha Vinholt, Ainsworth Alan Patrick, Detlefsen Sönke, Fristrup Claus Wilki, Knudsen Anja Oer, Mortensen Michael Bau, Tarpgaard Line Schmidt, Jochumsen Kirsten Marie, and Graversen Martin

Subjects
ovarian cancer, peritoneal metastasis, pressurized intraperitoneal aerosol chemotherapy (pipac), peritoneal regression grading score (prgs), quality of life (qol), Medicine, Specialties of internal medicine, RC581-951
Abstract

There are few data on Pressurized IntraPeritoneal Aerosol Chemotherapy with cisplatin and doxorubicin (PIPAC C/D) in women with primary unresectable or recurrent platinum-resistant peritoneal metastasis (PM) from ovarian cancer (OC). We evaluated survival, histological and cytological response, Quality of Life (QoL) and toxicity after PIPAC C/D in these patients.

Published
2024
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3. RNA expression profiling of peritoneal metastasis from pancreatic cancer treated with Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Author

Detlefsen Sönke, Burton Mark, Ainsworth Alan P., Fristrup Claus, Graversen Martin, Pfeiffer Per, Tarpgaard Line S., and Mortensen Michael B.

Subjects
pancreatic cancer, pressurized intraperitoneal aerosol chemotherapy (pipac), peritoneal metastasis, peritoneal regression grading score (prgs), rna profiling, transcriptomics, Medicine, Specialties of internal medicine, RC581-951
Abstract

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is an experimental treatment option in peritoneal metastasis from pancreatic cancer (PM-PC). Aims were to examine mRNA profile of fibrosis due to response after systemic chemotherapy and PIPAC (Regression) compared to treatment-naïve PM-PC and chronic cholecystitis–related peritoneal fibrosis (Controls).

Published
2024
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5. Review on treatment of pleural metastasis and malignant pleural effusion with Pressurized IntraThoracic Aerosol Chemotherapy (PITAC)

Author

Hansen Pernille Schjødt, Graversen Martin, Detlefsen Sönke, and Mortensen Michael Bau

Subjects
cytoreductive surgery, malignant pleural effusion, malignant pleural mesothelioma, palliative treatment, pressurized intrathoracic aerosol chemotherapy, Medicine, Specialties of internal medicine, RC581-951
Abstract

Malignant pleural effusion (MPE) is a common and debilitating condition seen in advanced cancer disease, and life-expectancy is short. Symptoms include pain and severe shortness of breath. Current first-line treatment options include pleural drainage using catheters as well as pleurodesis. However, these treatment modalities are often inefficient and patients need repeated procedures. Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) is a minimally invasive procedure, where antineoplastic agents are nebulized under pressure into the pleural space.

Published
2024
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6. What is long-term survival in patients with peritoneal metastasis from gastric, pancreatic, or colorectal cancer? A study of patients treated with systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Author

Kryh-Jensen Charlotte G., Fristrup Claus W., Ainsworth Alan P., Detlefsen Sönke, Mortensen Michael B., Pfeiffer Per, Tarpgaard Line S., and Graversen Martin

Subjects
long-term survival, peritoneal metastasis, pipac, response evaluation, prgs, Medicine, Specialties of internal medicine, RC581-951
Abstract

A definition of long-term survival (LTS) in patients with peritoneal metastasis (PM) from gastric cancer (GC), pancreatic cancer (PC) or colorectal cancer (CRC) treated with systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC) is lacking. We aimed to define LTS and investigate characteristics and treatment response in patients who reached LTS in data from two prospective trials.

Published
2023
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7. Correction: LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries

Author

Graupera, Isabel, Thiele, Maja, Ma, Ann T., Serra-Burriel, Miquel, Pich, Judit, Fabrellas, Núria, Caballeria, Llorenç, de Knegt, Robert J., Grgurevic, Ivica, Reichert, Mathias, Roulot, Dominique, Schattenberg, Jörn M., Pericas, Juan M., Angeli, Paolo, Tsochatzis, Emmanuel A., Guha, Indra Neil, Garcia-Retortillo, Montserrat, Morillas, Rosa M., Hernández, Rosario, Hoyo, Jordi, Fuentes, Matilde, Madir, Anita, Juanola, Adrià, Soria, Anna, Juan, Marta, Carol, Marta, Diaz, Alba, Detlefsen, Sönke, Toran, Pere, Pera, Guillem, Fournier, Céline, Llorca, Anne, Newsome, Phillip N., Manns, Michael, de Koning, Harry J., Serra-Burriel, Feliu, Cucchietti, Fernando, Arslanow, Anita, Korenjak, Marko, van Kleef, Laurens, Falcó, Josep Lluis, Kamath, Patrick S., Karlsen, Tom H., Castera, Laurent, Lammert, Frank, Krag, Aleksander, and Ginès, Pere

Published
2023
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8. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study

Author

Alvarez, Marifé, Andersen, Peter, Angeli, Paolo, Ardèvol, Alba, Arslanow, Anita, Beggiato, Luca, Ben Abdesselam, Zahia, Bennett, Lucy, Boutouria, Bajiha, Brocca, Alessandra, Broquetas, M. Teresa, Caballeria, Llorenç, Calvino, Valeria, Camacho, Judith, Capdevila, Aura, Carol, Marta, Castera, Laurent, Cervera, Marta, Cucchietti, Fernando, de Fuentes, Anna, de Knegt, Rob, de Koning, Harry J, Detlefsen, Sonke, Diaz, Alba, Diéguez Bande, José, Esnault, Vanessa, Fabrellas, Núria, Falcó, Josep Lluis, Fernández, Rosa, Fournier, Céline, Fuentes, Matilde, Galle, Peter, García, Edgar, García-Retortillo, Montserrat, Garrido, Esther, Ginès, Pere, Gordillo Medina, Rosa, Gratacós-Ginès, Jordi, Graupera, Isabel, Grgurevic, Ivica, Guha, Indra Neil, Guix, Eva, Hansen, Johanne Kragh, Harris, Rebecca, Hernández Boluda, Elena, Hernández-Ibañez, Rosario, Hoyo, Jordi, Ikram, Arfan, Incicco, Simone, Israelsen, Mads, Juan, Marta, Juanola, Adrià, Kaiser, Ralf, Kamath, Patrick S, Karlsen, Tom H, Kjærgaard, Maria, Korenjak, Marko, Krag, Aleksander, Krawczyk, Marcin, Laboulaye, Philippe, Lambert, Irina, Lammert, Frank, Langkjær Sørensen, Simon, Laserna-Jiménez, Cristina, Lazaro Pi, Sonia, Ledain, Elsa, Levy, Vincent, Lindvig, Katrine Prier, Llorca, Anne, Londoño, Vanessa, Loyer, Guirec, Ma, Ann T., Madir, Anita, Manns, Michael, Marshall, Denise, Martí, M. Lluïsa, Martínez, Sara, Martínez Sala, Ricard, Masa-Font, Roser, Møller Jensen, Jane, Morillas, Rosa M, Muñoz, Laura, Nadal, Ruth, Napoleone, Laura, Navarrete, JM, Newsome, Phillip N, Nielsen, Vibeke, Pérez, Martina, Pericás-Pulido, Juan Manuel, Piano, Salvatore, Pich, Judit, Pose, Elisa, Presas Escobet, Judit, Reichert, Matthias, Riba, Carlota, Roulot, Dominique, Rubio, Ana Belén, Sánchez-Morata, Maria, Schattenberg, Jörn, Serra-Burriel, Miquel, Serra-Burriel, Feliu, Skovborg Just, Louise, Sonneveld, Milan, Soria, Anna, Stern, Christiane, Such, Patricia, Thiele, Maja, Tonon, Marta, Toran, Pere, Torrejón, Antoni, Tsochatzis, Emmanuel A, van Kleef, Laurens, van Wijngaarden, Paulien, Velázquez, Vanessa, Viu, Ana, Weber, Susanne Nicole, Wildsmith, Tracey, Pera, Guillem, Reichert, Mathias, Pericàs, Juan M, Schattenberg, Jörn M, Tsochatztis, Emmanuel A, Garcia-Retortillo, Montserrat, Hernández, Rosario, Expósito, Carmen, Martínez, Alba, Detlefsen, Sönke, Martini, Andrea, Ma, Ann T, Pich, Judith, Bonfill, Eva, Navarrete, J M, Hernáez, Rubén, Allen, Alina, de Knegt, Robert J, and Wong, Vincent Wai-Sun

Published
2023
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9. OS-059 Unveiling Socioeconomic Disparities on Liver Disease: A Comparative Study of ALD, MASLD, and MetALD Patients

Author

Schnefeld, Helle Lindholm, primary, Hansen, Johanne Kragh, additional, Bech, Katrine Tholstrup, additional, Arslanow, Anita, additional, Graupera, Isabel, additional, Lindvig, Katrine Prier, additional, Kjærgaard, Maria, additional, Hansen, Camilla Dalby, additional, Israelsen, Mads, additional, Johansen, Stine, additional, Andersen, Peter, additional, Thorhauge, Katrine, additional, Torp, Nikolaj, additional, Detlefsen, Sönke, additional, Fabrellas, Núria, additional, Ginès, Pere, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2024
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10. SAT-266 Fibrosis stage progression in alcohol-related liver disease evaluated by repeated biopsies

Author

Jensen, Ellen Lyngbeck, primary, Torp, Nikolaj, additional, Johansen, Stine, additional, Thorhauge, Katrine, additional, Hansen, Camilla Dalby, additional, Hansen, Johanne Kragh, additional, Andersen, Peter, additional, Hansen, Emil Deleuran, additional, Villesen, Ida Falk, additional, Bech, Katrine Tholstrup, additional, Wernberg, Charlotte, additional, Lindvig, Katrine, additional, Detlefsen, Sönke, additional, Krag, Aleksander, additional, Thiele, Maja, additional, and Israelsen, Mads, additional

Published
2024
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11. WED-199 Optimizing MASLD trial recruitment: LiverPRO vs. FIB-4 in reducing false positives and unnecessary biopsies

Author

Lindvig, Katrine, primary, Alkhouri, Naim, additional, Nadeem, Rida, additional, Patel, Aarya, additional, Chughtai, Manal, additional, Hemant, Sahasraara, additional, Fallouh, Yasmeen, additional, Kapoor, Himanshi, additional, Hansen, Camilla Dalby, additional, Thorhauge, Katrine, additional, Hansen, Johanne Kragh, additional, Johansen, Stine, additional, Schnefeld, Helle, additional, Andersen, Peter, additional, Villesen, Ida Falk, additional, Bech, Katrine Tholstrup, additional, Torp, Nikolaj, additional, Detlefsen, Sönke, additional, Israelsen, Mads, additional, Thiele, Maja, additional, and Krag, Aleksander, additional

Published
2024
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12. OS-041-YI A spatiotemporal map of the hepatocyte proteome in alpha-1 antitrypsin deficiency by single-cell and visual proteomics

Author

Rosenberger, Florian, primary, Thorhauge, Katrine, additional, Mädler, Sophia, additional, Fromme, Malin, additional, Weiss, Caroline, additional, Oeller, Marc, additional, Steigerwald, Sophia, additional, Thielert, Marvin, additional, Nordmann, Thierry, additional, Detlefsen, Sönke, additional, Boor, Peter, additional, Fabián, Ondřej, additional, Fraňková, Soňa, additional, Krag, Aleksander, additional, Strnad, Pavel, additional, and Mann, Matthias, additional

Published
2024
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13. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries

Author

Graupera, Isabel, Thiele, Maja, Ma, Ann T., Serra-Burriel, Miquel, Pich, Judit, Fabrellas, Núria, Caballeria, Llorenç, de Knegt, Robert J., Grgurevic, Ivica, Reichert, Mathias, Roulot, Dominique, Schattenberg, Jörn M., Pericas, Juan M., Angeli, Paolo, Tsochatzis, Emmanuel A., Guha, Indra Neil, Garcia-Retortillo, Montserrat, Morillas, Rosa M., Hernández, Rosario, Hoyo, Jordi, Fuentes, Matilde, Madir, Anita, Juanola, Adrià, Soria, Anna, Juan, Marta, Carol, Marta, Diaz, Alba, Detlefsen, Sönke, Toran, Pere, Pera, Guillem, Fournier, Céline, Llorca, Anne, Newsome, Phillip N., Manns, Michael, de Koning, Harry J., Serra-Burriel, Feliu, Cucchietti, Fernando, Arslanow, Anita, Korenjak, Marko, van Kleef, Laurens, Falcó, Josep Lluis, Kamath, Patrick S., Karlsen, Tom H., Castera, Laurent, Lammert, Frank, Krag, Aleksander, and Ginès, Pere

Published
2022
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14. Importance of biopsy site selection for peritoneal regression grading score (PRGS) in peritoneal metastasis treated with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC)

Author

Fallah Mojib, Detlefsen Sönke, Ainsworth Alan P., Fristrup Claus W., Mortensen Michael B., Pfeiffer Per, Tarpgaard Line S., and Graversen Martin

Subjects
biopsy, clips marked, peritoneal metastasis, peritoneal regression grading score (prgs), pressurized intraperitoneal aerosol chemotherapy (pipac), Medicine, Specialties of internal medicine, RC581-951
Abstract

The four-tiered peritoneal regression grading score (PRGS) is used for histological response evaluation in patients with peritoneal metastasis (PM) treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC). Four quadrant biopsies (QBs) from the parietal peritoneum should be assessed by PRGS, but consensus on biopsy site strategy for follow-up biopsies during repeated PIPACs is lacking. We aimed to evaluate whether there is a difference between PRGS in QBs from clips marked PM (QB-CM) compared to biopsies from PM with the visually most malignant features (worst biopsy, WB).

Published
2022
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16. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer – A phase II study

Author

Weisz Ejlsmark, Mathilde, primary, Bahij, Rana, additional, Schytte, Tine, additional, Rønn Hansen, Christian, additional, Bertelsen, Anders, additional, Mahmood, Faisal, additional, Bau Mortensen, Michael, additional, Detlefsen, Sönke, additional, Weber, Britta, additional, Bernchou, Uffe, additional, and Pfeiffer, Per, additional

Published
2024
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17. Validation of NIAAAm-CRP criteria to predict alcohol-associated steatohepatitis on liver histology

Author

Stauber, Rudolf E., primary, Rautou, Pierre-Emmanuel, additional, Stefanescu, Horia, additional, Horhat, Adelina, additional, Thiele, Maja, additional, Lackner, Carolin, additional, Davies, Susan, additional, Denk, Helmut, additional, Detlefsen, Sönke, additional, Dienes, Hans Peter, additional, Gnemmi, Viviane, additional, Gouw, Annette S.H., additional, Guido, Maria, additional, Miquel, Rosa, additional, Paradis, Valerie, additional, Rusu, Ioana, additional, Schirmacher, Peter, additional, Terracciano, Luigi, additional, and Tiniakos, Dina, additional

Published
2024
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18. Infections increase the risk of decompensation and death in patients with early alcohol-related liver disease

Author

Johansen, Stine, Langkjær, Simon, Rasmussen, Ditlev Nytoft, Israelsen, Mads, Torp, Nikolaj, Lindvig, Katrine, Kjærgaard, Maria, Hansen, Johanne Kragh, Hansen, Camilla Dalby, Thorhauge, Katrine, Andersen, Peter, Detlefsen, Sönke, Juel, Helene Bæk, Justesen, Ulrik Stenz, Hansen, Torben, Krag, Aleksander, Thiele, Maja, Johansen, Stine, Langkjær, Simon, Rasmussen, Ditlev Nytoft, Israelsen, Mads, Torp, Nikolaj, Lindvig, Katrine, Kjærgaard, Maria, Hansen, Johanne Kragh, Hansen, Camilla Dalby, Thorhauge, Katrine, Andersen, Peter, Detlefsen, Sönke, Juel, Helene Bæk, Justesen, Ulrik Stenz, Hansen, Torben, Krag, Aleksander, and Thiele, Maja

Abstract

Background & Aims: Infections are frequent in patients with cirrhosis and worsen prognosis. We evaluated the incidence of infections and their impact on decompensation and death in patients with early alcohol-related liver disease (ALD) during long-term follow-up. Methods: We performed a prospective cohort study of patients in secondary care with a history of excess alcohol intake, no prior decompensation, and with liver biopsies along with clinical investigations conducted at baseline. During follow-up, we reviewed the patients’ electronic healthcare records for cases of infections, hospitalizations, transient elastography measurements, decompensations, all-cause mortality, and alcohol intake. Results: We included 461 patients with a mean age of 56±10 years (76% males; fibrosis stage F0-1/F2/F3-4 = 259/107/93 [56%/23%/20%]). During a median follow-up of 4.5 years (IQR 2.9-6.3), 134 patients (29%) developed a total of 312 infections, most frequently pneumonia (106/312, 34%) and urinary tract infections (57/312, 18%). Excessive alcohol intake during follow-up, smoking ≥30 pack years, MELD score and elevated liver stiffness during follow-up were independent predictors of infections. Patients who developed at least one infection had a significantly increased risk of subsequent decompensation (hazard ratio 4.98, 95% CI 2.47-10.03) and death (hazard ratio 8.24, 95% CI 4.65-14.59). Infections increased the risk of decompensation and death independently of baseline fibrosis stage, age, gender, and MELD score. Conclusions: Almost one-third of patients with early ALD develop an infection, which worsens their prognosis by increasing the risk of decompensation and death. The risk of infections increases with liver disease severity and ongoing harmful use of alcohol. Impact and implications: This study reveals that infections significantly worsen the prognosis of patients with early alcohol-related liver disease (ALD), increasing the likelihood of decompensation and deat

Published
2024

19. Exploring the prognostic value of circular RNAs in pancreatic ductal adenocarcinoma using genome-wide expression profiling.

Author

Ørbeck, Siri Vreim, Jakobsen, Theresa, García-Rodríguez, Juan Luis, Burton, Mark, Rasmussen, Lukas Gammelgaard, Ewald, Jesper Dupont, Fristrup, Claus Wilki, Pfeiffer, Per, Mortensen, Michael Bau, Kristensen, Lasse Sommer, and Detlefsen, Sönke

Abstract

Median survival of pancreatic ductal adenocarcinoma (PDAC) is around eight months and new prognostic tools are needed. Circular RNAs (circRNAs) have gained interest in different types of cancer. However, only a few studies have evaluated their potential in PDAC. We aimed to identify the most differentially expressed circRNAs in PDAC compared to controls and to explore their potential as prognostic markers. Using frozen specimens with PDAC and controls, we performed RNA sequencing and identified 20,440 unique circRNAs. A custom code set of capture- and reporter probes for NanoString nCounter analysis was designed to target 152 circRNAs, based on abundancy, differential expression and a literature study. Expression of these 152 circRNAs was examined in 108 formalin-fixed and paraffin-embedded surgical PDAC specimens and controls. The spatial expression of one of the most promising candidates, ciRS-7 (hsa_circ_0001946), was evaluated by chromogenic in situ hybridization (CISH) using multi-punch tissue microarrays (TMAs) and digital imaging analysis. Based on circRNA expression profiles, we identified different PDAC subclusters. The 30 most differentially expressed circRNAs showed log2 fold changes from −3.43 to 0.94, where circNRIP1 (hsa_circ_0004771), circMBOAT2 (hsa_circ_0007334) and circRUNX1 (hsa_circ_0002360) held significant prognostic value in multivariate analysis. CiRS-7 was absent in PDAC cells but highly expressed in the tumor microenvironment. We identified several new circRNAs with biomarker potential in surgically treated PDAC, three of which showed an independent prognostic value. We also found that ciRS-7 is absent in cancer cells but abundant in tumor microenvironment and may hold potential as marker of activated stroma. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Identification of tumour regression in neoadjuvantly treated pancreatic cancer is based on divergent and nonspecific criteria.

Author

Holm, Maia Blomhoff, Lenggenhager, Daniela, Detlefsen, Sönke, Sántha, Petra, and Verbeke, Caroline Sophie

Subjects
PANCREATIC cancer, TUMORS, NEOADJUVANT chemotherapy, TUMOR markers, IDENTIFICATION, TREATMENT effectiveness
Abstract

Aims: Following the increased use of neoadjuvant therapy for pancreatic cancer, grading of tumour regression (TR) has become part of routine diagnostics. However, it suffers from marked interobserver variation, which is mainly ascribed to the subjectivity of the defining criteria of the categories in TR grading systems. We hypothesized that a further cause for the interobserver variation is the use of divergent and nonspecific morphological criteria to identify tumour regression. Methods and Results: Twenty treatment‐naïve pancreatic cancers and 20 pancreatic cancers treated with neoadjuvant chemotherapy were reviewed by three experienced pancreatic pathologists who, blinded for treatment status, categorized each tumour as treatment‐naïve or neoadjuvantly treated, and annotated all tissue areas they considered showing tumour regression. Only 50%–65% of the cases were categorized correctly, and the annotated tissue areas were highly discrepant (only 3%–41% overlap). When the prevalence of various morphological features deemed to indicate TR was compared between treatment‐naïve and neoadjuvantly treated tumours, only one pattern, characterized by reduced cancer cell density and prominent stroma affecting a large area of the tumour bed, occurred significantly more frequently, but not exclusively, in the neoadjuvantly treated group. Finally, stromal features, both morphological and biological, were investigated as possible markers for tumour regression, but failed to distinguish TR from native tumour stroma. Conclusion: There is considerable divergence in opinion between pathologists when it comes to the identification of tumour regression. Reliable identification of TR is only possible if it is extensive, while lesser degrees of treatment effect cannot be recognized with certainty. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Infections Increase The Risk Of Decompensation And Death In Patients With Early Alcohol-Related Liver Disease

Author

Johansen, Stine, primary, Langkjær, Simon, additional, Rasmussen, Ditlev Nytoft, additional, Israelsen, Mads, additional, Torp, Nikolaj, additional, Lindvig, Katrine, additional, Kjærgaard, Maria, additional, Hansen, Johanne Kragh, additional, Hansen, Camilla Dalby, additional, Thorhauge, Katrine, additional, Andersen, Peter, additional, Detlefsen, Sönke, additional, Juel, Helene Bæk, additional, Justesen, Ulrik Stenz, additional, Hansen, Torben, additional, Krag, Aleksander, additional, Thiele, Maja, additional, Anastasiadou, Ema, additional, Arumugam, Manimozhian, additional, Bork, Peer, additional, Presto, Jenny, additional, Israelsen, Hans, additional, Karsdal, Morten, additional, Legido-Quigley, Cristina, additional, Melberg, Hans Olav, additional, Trebicka, Jonel, additional, Mann, Mathias, additional, and Matthijnssens, Jelle, additional

Published
2024
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22. LiverPRO for the Prediction of Significant Liver Fibrosis in Primary Care: Development, Validation, and Prognostic Evaluation of a Novel Score

Author

Lindvig, Katrine Prier, primary, Thorhauge, Katrine Holtz, additional, Hansen, Johanne Kragh, additional, Kjaergaard, Maria, additional, Hansen, Camilla Dalby, additional, Johansen, Stine, additional, Jensen, Ellen Lyngbeck, additional, Israelsen, Mads, additional, Andersen, Peter, additional, Bech, Katrine Tholstrup, additional, Torp, Nikolaj Christian, additional, Schnefeld, Helle Lindholm, additional, Detlefsen, Sönke, additional, Möller, Sören, additional, Graupera, Isabel, additional, Trelle, Morten beck, additional, Antonsen, Steen, additional, Harris, Rebecca, additional, Kårhus, Line Lund, additional, Bjørnsbo, Kirsten Schroll, additional, Brøns, Charlotte, additional, Hansen, Torben, additional, Geier, Andreas, additional, Wedemeyer, Heiner, additional, Zeuzem, Stefan, additional, Gines, Pere, additional, Guha, Indra Neil, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2024
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24. High overall copy number variation burden by genome-wide methylation profiling holds negative prognostic value in surgically treated pancreatic ductal adenocarcinoma

Author

Detlefsen, Sönke, primary, Boldt, Henning Bünsow, additional, Burton, Mark, additional, Thomsen, Mikkel Marschall, additional, Rasmussen, Lukas Gammelgaard, additional, Ørbeck, Siri Vreim, additional, Pfeiffer, Per, additional, Mortensen, Michael Bau, additional, and de Stricker, Karin, additional

Published
2023
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25. Screening for fibrosis promotes life-style changes. A prospective cohort study in 4,796 individuals

Author

Kjaergaard, Maria, primary, Lindvig, Katrine Prier, additional, Thorhauge, Katrine Holtz, additional, Johansen, Stine, additional, Hansen, Johanne Kragh, additional, Andersen, Peter, additional, Hansen, Camilla Dalby, additional, Schnefeld, Helle Lindholm, additional, Bech, Katrine Tholstrup, additional, Torp, Nikolaj, additional, Israelsen, Mads, additional, Detlefsen, Sönke, additional, Graupera, Isabel, additional, Gines, Pere, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2023
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27. Expression of FIBCD1 by intestinal epithelial cells alleviates inflammation-driven tumorigenesis in a mouse model of colorectal cancer

Author

Shahgoli, Vahid Khaze, primary, Dubik, Magdalena, additional, Pilecki, Bartosz, additional, Skallerup, Sofie, additional, Schmidt, Sandra Gaedt, additional, Detlefsen, Sönke, additional, Sorensen, Grith L., additional, Holmskov, Uffe, additional, Baradaran, Behzad, additional, and Moeller, Jesper B., additional

Published
2023
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28. Single cell-resolved study of advanced murine MASH reveals a homeostatic pericyte signaling module

Author

Bendixen, Sofie M., primary, Jakobsgaard, Peter R., additional, Hansen, Daniel, additional, Hejn, Kamilla H., additional, Terkelsen, Mike K., additional, Bjerre, Frederik A., additional, Thulesen, Annemette P., additional, Eriksen, Niels G., additional, Hallenborg, Philip, additional, Geng, Yana, additional, Dam, Trine V., additional, Larsen, Frederik T., additional, Wernberg, Charlotte W., additional, Vijayathurai, Janusa, additional, Scott, Emma A.H., additional, Marcher, Ann-Britt, additional, Detlefsen, Sönke, additional, Grøntved, Lars, additional, Dimke, Henrik, additional, Berdeaux, Rebecca, additional, de Aguiar Vallim, Thomas Q., additional, Olinga, Peter, additional, Lauridsen, Mette M., additional, Krag, Aleksander, additional, Blagoev, Blagoy, additional, and Ravnskjaer, Kim, additional

Published
2023
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30. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study

Author

Serra-Burriel, Miquel, primary, Juanola, Adrià, additional, Serra-Burriel, Feliu, additional, Thiele, Maja, additional, Graupera, Isabel, additional, Pose, Elisa, additional, Pera, Guillem, additional, Grgurevic, Ivica, additional, Caballeria, Llorenç, additional, Piano, Salvatore, additional, van Kleef, Laurens, additional, Reichert, Mathias, additional, Roulot, Dominique, additional, Pericàs, Juan M, additional, Schattenberg, Jörn M, additional, Tsochatztis, Emmanuel A, additional, Guha, Indra Neil, additional, Garcia-Retortillo, Montserrat, additional, Hernández, Rosario, additional, Hoyo, Jordi, additional, Fuentes, Matilde, additional, Expósito, Carmen, additional, Martínez, Alba, additional, Such, Patricia, additional, Madir, Anita, additional, Detlefsen, Sönke, additional, Tonon, Marta, additional, Martini, Andrea, additional, Ma, Ann T, additional, Pich, Judith, additional, Bonfill, Eva, additional, Juan, Marta, additional, Soria, Anna, additional, Carol, Marta, additional, Gratacós-Ginès, Jordi, additional, Morillas, Rosa M, additional, Toran, Pere, additional, Navarrete, J M, additional, Torrejón, Antoni, additional, Fournier, Céline, additional, Llorca, Anne, additional, Arslanow, Anita, additional, de Koning, Harry J, additional, Cucchietti, Fernando, additional, Manns, Michael, additional, Newsome, Phillip N, additional, Hernáez, Rubén, additional, Allen, Alina, additional, Angeli, Paolo, additional, de Knegt, Robert J, additional, Karlsen, Tom H, additional, Galle, Peter, additional, Wong, Vincent Wai-Sun, additional, Fabrellas, Núria, additional, Castera, Laurent, additional, Krag, Aleksander, additional, Lammert, Frank, additional, Kamath, Patrick S, additional, Ginès, Pere, additional, Alvarez, Marifé, additional, Andersen, Peter, additional, Ardèvol, Alba, additional, Beggiato, Luca, additional, Ben Abdesselam, Zahia, additional, Bennett, Lucy, additional, Boutouria, Bajiha, additional, Brocca, Alessandra, additional, Broquetas, M. Teresa, additional, Calvino, Valeria, additional, Camacho, Judith, additional, Capdevila, Aura, additional, Cervera, Marta, additional, de Fuentes, Anna, additional, de Knegt, Rob, additional, Detlefsen, Sonke, additional, Diaz, Alba, additional, Diéguez Bande, José, additional, Esnault, Vanessa, additional, Falcó, Josep Lluis, additional, Fernández, Rosa, additional, García, Edgar, additional, García-Retortillo, Montserrat, additional, Garrido, Esther, additional, Gordillo Medina, Rosa, additional, Guix, Eva, additional, Hansen, Johanne Kragh, additional, Harris, Rebecca, additional, Hernández Boluda, Elena, additional, Hernández-Ibañez, Rosario, additional, Ikram, Arfan, additional, Incicco, Simone, additional, Israelsen, Mads, additional, Kaiser, Ralf, additional, Kjærgaard, Maria, additional, Korenjak, Marko, additional, Krawczyk, Marcin, additional, Laboulaye, Philippe, additional, Lambert, Irina, additional, Langkjær Sørensen, Simon, additional, Laserna-Jiménez, Cristina, additional, Lazaro Pi, Sonia, additional, Ledain, Elsa, additional, Levy, Vincent, additional, Lindvig, Katrine Prier, additional, Londoño, Vanessa, additional, Loyer, Guirec, additional, Ma, Ann T., additional, Marshall, Denise, additional, Martí, M. Lluïsa, additional, Martínez, Sara, additional, Martínez Sala, Ricard, additional, Masa-Font, Roser, additional, Møller Jensen, Jane, additional, Muñoz, Laura, additional, Nadal, Ruth, additional, Napoleone, Laura, additional, Navarrete, JM, additional, Nielsen, Vibeke, additional, Pérez, Martina, additional, Pericás-Pulido, Juan Manuel, additional, Pich, Judit, additional, Presas Escobet, Judit, additional, Reichert, Matthias, additional, Riba, Carlota, additional, Rubio, Ana Belén, additional, Sánchez-Morata, Maria, additional, Schattenberg, Jörn, additional, Serra-Burriel, Miquel, additional, Skovborg Just, Louise, additional, Sonneveld, Milan, additional, Stern, Christiane, additional, Tsochatzis, Emmanuel A, additional, van Wijngaarden, Paulien, additional, Velázquez, Vanessa, additional, Viu, Ana, additional, Weber, Susanne Nicole, additional, and Wildsmith, Tracey, additional

Published
2023
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32. Germline pathogenic variants in patients with high-grade gastroenteropancreatic neuroendocrine neoplasms

Author

Venizelos, Andreas, primary, Sorbye, Halfdan, additional, Elvebakken, Hege, additional, Perren, Aurel, additional, Lothe, Inger Marie B, additional, Couvelard, Anne, additional, Hjortland, Geir Olav, additional, Sundlöv, Anna, additional, Svensson, Johanna, additional, Garresori, Harrish, additional, Kersten, Christian, additional, Hofsli, Eva, additional, Detlefsen, Sönke, additional, Vestermark, Lene W, additional, Ladekarl, Morten, additional, Tabaksblat, Elizaveta Mitkina, additional, and Knappskog, Stian, additional

Published
2023
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33. A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01)

Author

Rasmussen, Louise Skau, primary, Winther, Stine B., additional, Chen, Inna M., additional, Weber, Britta, additional, Ventzel, Lise, additional, Liposits, Gabor, additional, Johansen, Julia Sidenius, additional, Detlefsen, Sönke, additional, Egendal, Ida, additional, Shim, Susy, additional, Christensen, Signe, additional, Pfeiffer, Per, additional, and Ladekarl, Morten, additional

Published
2023
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34. Health-related quality of life in a population at-risk of NAFLD or ArLD

Author

Schnefeld, Helle Lindholm, primary, Lindvig, Katrine Prier, additional, Arslanow, Anita, additional, Graupera, Isabel, additional, Kjærgaard, Maria, additional, Thorhauge, Katrine, additional, Hansen, Johanne Kragh, additional, Hansen, Camilla Dalby, additional, Johansen, Stine, additional, Israelsen, Mads, additional, Andersen, Peter, additional, Torp, Nikolaj, additional, Bech, Katrine, additional, Detlefsen, Sönke, additional, Fabrellas, Núria, additional, Ginès, Pere, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2023
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35. Soluble TREM2 and PRO-C3 as efficacy of intervention markers in NASH

Author

Wernberg, Charlotte, primary, Chandran, Vineesh Indira, additional, Lauridsen, Mette, additional, Skytthe, Maria Kløjgaard, additional, Hansen, Camilla Dalby, additional, Hansen, Johanne Kragh, additional, Grønkjær, Lea Ladegaard, additional, Jacobsen, Birgitte, additional, Di Caterino, Tina, additional, Detlefsen, Sönke, additional, Thiele, Maja, additional, Guiliani, Alejandro Mayorca, additional, Leeming, Diana, additional, Karsdal, Morten, additional, Villesen, Ida, additional, Graversen, Jonas, additional, and Krag, Aleksander, additional

Published
2023
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36. Clinical course of biopsy-controlled alcohol-related liver disease

Author

Johansen, Stine, primary, Israelsen, Mads, additional, Torp, Nikolaj, additional, Thorhauge, Katrine, additional, Hansen, Johanne Kragh, additional, Lindvig, Katrine Prier, additional, Andersen, Peter, additional, Hansen, Emil Deleuran, additional, Hansen, Camilla Dalby, additional, Spedtsberg, Ida Ziegler, additional, Villesen, Ida, additional, Bech, Katrine, additional, Detlefsen, Sönke, additional, Juel, Helene Bæk, additional, Rasmussen, Ditlev, additional, Hansen, Torben, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2023
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37. Cardiovascular events in patients with alcohol-related liver disease and the prognostic value of endotrophin assessed by PRO-C6

Author

Spedtsberg, Ida Ziegler, primary, Villesen, Ida, additional, Johansen, Stine, additional, Hansen, Johanne Kragh, additional, Lindvig, Katrine Prier, additional, Andersen, Peter, additional, Torp, Nikolaj, additional, Israelsen, Mads, additional, Hansen, Camilla Dalby, additional, Thorhauge, Katrine, additional, Bech, Katrine, additional, Hansen, Emil Deleuran, additional, Detlefsen, Sönke, additional, Leeming, Diana, additional, Karsdal, Morten, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2023
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38. A cost-comparison of the LiverPRO score with FIB-4, ELF, and FibroScan in 6,032 study participants

Author

Lindvig, Katrine Prier, primary, Kjærgaard, Maria, additional, Thorhauge, Katrine, additional, Jensen, Ellen, additional, Hansen, Johanne Kragh, additional, Hansen, Camilla Dalby, additional, Johansen, Stine, additional, Israelsen, Mads, additional, Andersen, Peter, additional, Torp, Nikolaj, additional, Schnefeld, Helle Lindholm, additional, Detlefsen, Sönke, additional, Posselt, Mathias, additional, Kastrup, Nanna, additional, Holtug, Taus, additional, Krag, Aleksander, additional, and Thiele, Maja, additional

Published
2023
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39. Rifaximin-α for liver fibrosis in patients with alcohol-related liver disease (GALA-RIF): a randomised, double-blind, placebo-controlled, phase 2 trial

Author

Israelsen, Mads, primary, Madsen, Bjørn Stæhr, additional, Torp, Nikolaj, additional, Johansen, Stine, additional, Hansen, Camilla Dalby, additional, Detlefsen, Sönke, additional, Andersen, Peter, additional, Hansen, Johanne Kragh, additional, Lindvig, Katrine Prier, additional, Rasmussen, Ditlev Nytoft, additional, Thorhauge, Katrine Holtz, additional, Kjærgaard, Maria, additional, Karsdal, Morten, additional, Hansen, Torben, additional, Arumugam, Manimozhiyan, additional, Trebicka, Jonel, additional, Thiele, Maja, additional, Krag, Aleksander, additional, Anastasiadou, Ema, additional, Arumugam, Manimozhian, additional, Bork, Peer, additional, Henrar, Roland, additional, Israelsen, Hans, additional, Legido-Quigley, Cristina, additional, Melberg, Hans Olav, additional, Mann, Mathias, additional, and Matthijnssens, Jelle, additional

Published
2023
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42. Tissue amount and diagnostic yield of a novel franseen EUS-FNB and a standard EUS-FNA needle—A randomized controlled study in solid pancreatic lesions

Author

Kovacevic, Bojan, primary, Toxværd, Anders, additional, Klausen, Pia, additional, Larsen, Michael H., additional, Grützmeier, Simon, additional, Detlefsen, Sönke, additional, Karstensen, John Gásdal, additional, Brink, Lene, additional, Hassan, Hazem, additional, Høgdall, Estrid, additional, and Vilmann, Peter, additional

Published
2023
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43. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease

Author

Kjaergaard, Maria, primary, Lindvig, Katrine Prier, additional, Thorhauge, Katrine Holtz, additional, Andersen, Peter, additional, Hansen, Johanne Kragh, additional, Kastrup, Nanna, additional, Jensen, Jane Møller, additional, Hansen, Camilla Dalby, additional, Johansen, Stine, additional, Israelsen, Mads, additional, Torp, Nikolaj, additional, Trelle, Morten Beck, additional, Shan, Shan, additional, Detlefsen, Sönke, additional, Antonsen, Steen, additional, Andersen, Jørgen Ellegaard, additional, Graupera, Isabel, additional, Ginés, Pere, additional, Thiele, Maja, additional, and Krag, Aleksander, additional

Published
2023
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44. A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01)

Author

Rasmussen, Louise Skau, Winther, Stine B., Chen, Inna M., Weber, Britta, Ventzel, Lise, Liposits, Gabor, Johansen, Julia Sidenius, Detlefsen, Sönke, Egendal, Ida, Shim, Susy, Christensen, Signe, Pfeiffer, Per, Ladekarl, Morten, Rasmussen, Louise Skau, Winther, Stine B., Chen, Inna M., Weber, Britta, Ventzel, Lise, Liposits, Gabor, Johansen, Julia Sidenius, Detlefsen, Sönke, Egendal, Ida, Shim, Susy, Christensen, Signe, Pfeiffer, Per, and Ladekarl, Morten

Abstract

Background: According to current evidence, the best treatment for fit patients with non-resectable pancreatic cancer (PC) is combination chemotherapy, whereas frail patients are recommended gemcitabine (Gem) monotherapy. Randomized controlled trials in colorectal cancer and a post-hoc analysis of gemcitabine and nab-paclitaxel (GemNab) in PC suggest, however, that reduced dose of combination chemotherapy may be feasible and more efficient compared to monotherapy in frail patients. The aim of this study is to investigate whether reduced dose GemNab is superior to full dose Gem in patients with resectable PC, who are not candidates for full dose combination chemotherapy in first line. Methods: The Danish Pancreas Cancer Group (DPCG)-01 trial is a national multicenter prospective randomized phase II trial. A total of 100 patients in ECOG performance status 0–2 with non-resectable PC, not candidate for full dose combination chemotherapy in first line, but eligible for full dose Gem, will be included. Patients are randomized 1:1 to either full dose Gem or GemNab in 80% of recommended dose. The primary endpoint is progression-free survival. Secondary endpoints are overall survival, overall response rate, quality of life, toxicity and rate of hospitalizations during treatment. The correlation between blood inflammatory markers, including YKL-40 and IL-6, circulating tumor DNA, and tissue biomarkers of resistance to chemotherapy and outcome will be explored. Finally, the study will include measures of frailty (G8, modified G8, and chair-stand-test) to assess whether scoring would enable a personalized allocation to different treatments or indicates a possibility for interventions. Discussion: Single-drug treatment with Gem has for frail patients with non-resectable PC been the main treatment option for more than thirty years, but the impact on outcome is modest. If improved results and sustained tolerability with reduced dose combination chemotherapy can be shown, this c

Published
2023

45. Sphingolipids Are Depleted in Alcohol-Related Liver Fibrosis

Author

Thiele, Maja, Suvitaival, Tommi, Trošt, Kajetan, Kim, Min, de Zawadzki, Andressa, Kjaergaard, Maria, Rasmussen, Ditlev Nytoft, Lindvig, Katrine Prier, Israelsen, Mads, Detlefsen, Sönke, Andersen, Peter, Juel, Helene Bæk, Nielsen, Trine, Georgiou, Stella, Filippa, Vicky, Kuhn, Michael, Nishijima, Suguru, Moitinho-Silva, Lucas, Rossing, Peter, Trebicka, Jonel, Anastasiadou, Ema, Bork, Peer, Hansen, Torben, Legido-Quigley, Cristina, Krag, Aleksander, Mann, Mathias, Matthijnssens, Jelle, Arumugam, Manimozhiyan, Henrar, Roland, Israelsen, Hans, Karsdal, Morten, Melberg, Hans Olav, Thiele, Maja, Suvitaival, Tommi, Trošt, Kajetan, Kim, Min, de Zawadzki, Andressa, Kjaergaard, Maria, Rasmussen, Ditlev Nytoft, Lindvig, Katrine Prier, Israelsen, Mads, Detlefsen, Sönke, Andersen, Peter, Juel, Helene Bæk, Nielsen, Trine, Georgiou, Stella, Filippa, Vicky, Kuhn, Michael, Nishijima, Suguru, Moitinho-Silva, Lucas, Rossing, Peter, Trebicka, Jonel, Anastasiadou, Ema, Bork, Peer, Hansen, Torben, Legido-Quigley, Cristina, Krag, Aleksander, Mann, Mathias, Matthijnssens, Jelle, Arumugam, Manimozhiyan, Henrar, Roland, Israelsen, Hans, Karsdal, Morten, and Melberg, Hans Olav

Abstract

Background & Aims: Alcohol disturbs hepatic lipid synthesis and transport, but the role of lipid dysfunction in alcohol-related liver disease (ALD) is unclear. In this biopsy-controlled, prospective, observational study, we characterized the liver and plasma lipidomes in patients with early ALD. Methods: We performed mass spectrometry–based lipidomics of paired liver and plasma samples from 315 patients with ALD and of plasma from 51 matched healthy controls. We associated lipid levels with histologic fibrosis, inflammation, and steatosis with correction for multiple testing and adjustment for confounders. We further investigated sphingolipid regulation by means of quantitative real-time polymerase chain reaction sequencing of microRNA, prediction of liver-related events, and tested causality with Mendelian randomization. Results: We detected 198 lipids in the liver and 236 lipids in the circulation from 18 lipid classes. Most sphingolipids (sphingomyelins and ceramides) and phosphocholines were co–down-regulated in both liver and plasma, where lower abundance correlated with higher fibrosis stage. Sphingomyelins showed the most pronounced negative correlation to fibrosis, mirrored by negative correlations in both liver and plasma with hepatic inflammation. Reduced sphingomyelins predicted future liver-related events. This seemed to be characteristic of “pure ALD,” as sphingomyelin levels were higher in patients with concomitant metabolic syndrome and ALD/nonalcoholic fatty liver disease overlap. Mendelian randomization in FinnGen and UK Biobanks indicated ALD as the cause of low sphingomyelins, and alcohol use disorder did not correlate with genetic susceptibility to low sphingomyelin levels. Conclusions: Alcohol-related liver fibrosis is characterized by selective and progressive lipid depletion in liver and blood, particularly sphingomyelins, which also associates with progression to liver-related events.

Published
2023

46. Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease:A Randomized Controlled Trial

Author

Hansen, Camilla Dalby, Gram-Kampmann, Eva-Marie, Hansen, Johanne Kragh, Hugger, Mie Balle, Madsen, Bjørn Stæhr, Jensen, Jane Møller, Olesen, Sara, Torp, Nikolaj, Rasmussen, Ditlev Nytoft, Kjærgaard, Maria, Johansen, Stine, Lindvig, Katrine Prier, Andersen, Peter, Thorhauge, Katrine Holtz, Brønd, Jan Christian, Hermann, Pernille, Beck-Nielsen, Henning, Detlefsen, Sönke, Hansen, Torben, Højlund, Kurt, Thiele, Maja Sofie, Israelsen, Mads, Krag, Aleksander, Hansen, Camilla Dalby, Gram-Kampmann, Eva-Marie, Hansen, Johanne Kragh, Hugger, Mie Balle, Madsen, Bjørn Stæhr, Jensen, Jane Møller, Olesen, Sara, Torp, Nikolaj, Rasmussen, Ditlev Nytoft, Kjærgaard, Maria, Johansen, Stine, Lindvig, Katrine Prier, Andersen, Peter, Thorhauge, Katrine Holtz, Brønd, Jan Christian, Hermann, Pernille, Beck-Nielsen, Henning, Detlefsen, Sönke, Hansen, Torben, Højlund, Kurt, Thiele, Maja Sofie, Israelsen, Mads, and Krag, Aleksander

Abstract

BACKGROUND: It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.OBJECTIVE: To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.DESIGN: 6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).SETTING: Odense University Hospital in Denmark from November 2016 until June 2020.PARTICIPANTS: 165 participants with T2DM.INTERVENTION: Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.MEASUREMENTS: Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.RESULTS: The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A1c (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.LIMITATION: Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.

Published
2023

47. Tissue amount and diagnostic yield of a novel franseen EUS-FNB and a standard EUS-FNA needle-A randomized controlled study in solid pancreatic lesions

Author

Kovacevic, Bojan, Toxværd, Anders, Klausen, Pia, Larsen, Michael H, Grützmeier, Simon, Detlefsen, Sönke, Karstensen, John Gásdal, Brink, Lene, Hassan, Hazem, Høgdall, Estrid, Vilmann, Peter, Kovacevic, Bojan, Toxværd, Anders, Klausen, Pia, Larsen, Michael H, Grützmeier, Simon, Detlefsen, Sönke, Karstensen, John Gásdal, Brink, Lene, Hassan, Hazem, Høgdall, Estrid, and Vilmann, Peter

Abstract

Background and Objectives Several types of needles are available for EUS–guided tissue sampling of pancreatic lesions. Whereas fine-needle aspiration (FNA) needles typically provide cytological samples, fine-needle biopsy (FNB) needles are designed to obtain microcores with preserved tissue architecture. The aim of this study was to compare tissue amount and diagnostic yield between a modified Franseen-type FNB needle (TopGain; Medi-Globe GmbH, Grassau, Germany) and a standard FNA needle. Methods We performed a prospective, multicenter randomized controlled study between June 2020 and September 2021, including patients with a solid pancreatic lesion referred for EUS-guided tissue sampling at 3 centers in Denmark. The patients were randomized 1:1 to either FNA needle or the novel FNB needle. Primary outcomes included the number of obtained tissue microcores and total and diagnostic tissue area. Results Sixty-four patients were included. The median number of tissue microcores procured per pass was significantly higher in the FNB group compared with FNA (3 vs. 2, P < 0.001). Similarly, the mean total tissue area (2.74 vs. 0.44 mm2, P < 0.001) and mean diagnostic tissue area (1.74 vs. 0.28 mm2, P < 0.001) were more than 6-fold larger in the FNB samples compared with FNA. The median number of passes needed for a diagnostic sample was 1 for the FNB needle and 2 for FNA needle (P = 0.12). The novel FNB needle provided a higher percentage of samples of excellent quality (P = 0.002). Conclusions The novel Franseen-type FNB needle seems to be significantly superior to a conventional FNA needle. The results of this study underline excellent performance of crown-cut needles., BACKGROUND AND OBJECTIVES: Several types of needles are available for EUS-guided tissue sampling of pancreatic lesions. Whereas fine-needle aspiration (FNA) needles typically provide cytological samples, fine-needle biopsy (FNB) needles are designed to obtain microcores with preserved tissue architecture. The aim of this study was to compare tissue amount and diagnostic yield between a modified Franseen-type FNB needle (TopGain; Medi-Globe GmbH, Grassau, Germany) and a standard FNA needle.METHODS: We performed a prospective, multicenter randomized controlled study between June 2020 and September 2021, including patients with a solid pancreatic lesion referred for EUS-guided tissue sampling at 3 centers in Denmark. The patients were randomized 1:1 to either FNA needle or the novel FNB needle. Primary outcomes included the number of obtained tissue microcores and total and diagnostic tissue area.RESULTS: Sixty-four patients were included. The median number of tissue microcores procured per pass was significantly higher in the FNB group compared with FNA (3 vs. 2, P < 0.001). Similarly, the mean total tissue area (2.74 vs. 0.44 mm2, P < 0.001) and mean diagnostic tissue area (1.74 vs. 0.28 mm2, P < 0.001) were more than 6-fold larger in the FNB samples compared with FNA. The median number of passes needed for a diagnostic sample was 1 for the FNB needle and 2 for FNA needle (P = 0.12). The novel FNB needle provided a higher percentage of samples of excellent quality (P = 0.002).CONCLUSIONS: The novel Franseen-type FNB needle seems to be significantly superior to a conventional FNA needle. The results of this study underline excellent performance of crown-cut needles.

Published
2023

48. Prognostic significance of margin clearance in pancreaticoduodenectomy specimens with pancreatic ductal adenocarcinoma in a Danish population-based nationwide study

Author

Aaquist, Trine, Fristrup, Claus W., Hasselby, Jane P., Hamilton-Dutoit, Stephen, Eld, Mikkel, Pfeiffer, Per, Mortensen, Michael B., Detlefsen, Sönke, Aaquist, Trine, Fristrup, Claus W., Hasselby, Jane P., Hamilton-Dutoit, Stephen, Eld, Mikkel, Pfeiffer, Per, Mortensen, Michael B., and Detlefsen, Sönke

Abstract

Background: In this nationwide population-based cohort study, we investigated the overall minimum margin width that is independently associated with improved survival following pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC) and evaluated whether certain margins or surfaces hold independent prognostic significance. Methods: Data from 367 patients who underwent PD for PDAC in the period 2015–2019 were retrieved from the Danish Pancreatic Cancer Database. Missing data were obtained by review of pathology reports and re-microscopy of resection specimens. Surgical specimens were evaluated using a standardised pathological protocol involving multicolour inking, axial slicing and exact reporting of circumferential margin clearances in 0.5 mm increments. Results: When categorised according to margin widths of <0.5, <1.0, <1.5, <2.0, <2.5 and <3.0 mm, R1 resections were detected in 34%, 57%, 75%, 78%, 86% and 87% of cases, respectively. In multivariable analyses, an overall margin clearance of ≥1.5 mm was associated with improved survival compared with a clearance of <1.5 mm (HR 0.70 95% CI 0.51–0.97 (p = 0.031)). When evaluating the margins separately, no margin had independent prognostic significance. Conclusion: Margin clearance of at least 1.5 mm was independently associated with improved survival following PD for PDAC.

Published
2023

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