A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh
The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).
The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.

开始日期2024-05-01

申办/合作机构

Paracelsus Private Medical University of Salzburg

[+3]

NCT06391892 / Recruiting临床3期IIT

Liquid Biopsy Guided Treatment in Localized Pancreatic Cancer (LIQUIPANC): Circulating Tumor DNA (ctDNA) as Precision Medicine Tool for Stratification of Neoadjuvant Chemotherapy vs. Upfront Surgery

This study evaluates the clinical prognostic impact (on DFS and OS) of liquid biopsy guided treatment vs. standard of care (physicians choice) in localized pancreatic cancer (despite because of CA 19-9 levels and computed tomography, upfront surgery is recommended by tumor board). ctDNA positive patients will receive neoadjvuant chemotherapy at current gold standard physicians choice instead of upfront surgery, because of assumed high biological risk for early recurrence.

开始日期2024-01-11

申办/合作机构

Krankenhaus der Elisabethinen Linz GmbH

[+1]

100 项与 Krankenhaus der Elisabethinen Linz GmbH 相关的临床结果

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0 项与 Krankenhaus der Elisabethinen Linz GmbH 相关的专利（医药）

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项与 Krankenhaus der Elisabethinen Linz GmbH 相关的文献（医药）

2023-12-01·JDDG: Journal der Deutschen Dermatologischen Gesellschaft

Entwicklung der Patientencharakteristika und der Wirksamkeit der Biologika‐Therapie bei Patienten des Österreichischen Psoriasis‐Registers von 2004 bis 2022

Article

作者: Sator, Paul ; Legat, Franz ; Vujic, Igor ; Häring, Nina ; Weger, Wolfgang ; Schmuth, Matthias ; Trattner, Hannes ; Prillinger, Knut ; Wolf, Peter ; Müllegger, Robert ; Falkensteiner, Katharina ; Wippel-Slupetzky, Katharina ; Sadoghi, Birgit ; Gruber-Wackernagel, Alexandra ; Mlynek, Alexander ; Ellersdorfer, Christina ; Salmhofer, Wolfgang ; Ratzinger, Gudrun ; Skvara, Hans ; Schütz-Bergmayr, Martina ; Painsi, Clemens ; Hofer, Angelika ; Jonak, Constanze ; Richter, Leo ; Quehenberger, Franz ; Gruber, Barbara ; Graier, Thomas ; Saxinger, Werner ; Lange-Asschenfeldt, Bernhard ; Zikeli, Claudia ; Sassmann, Christoph ; Bangert, Christina ; Inzinger, Martin ; Hötzenecker, Wolfram

2022-06-01·Annals of Surgery1区 · 医学

Surgical Outcomes After Neoadjuvant Chemoradiation Followed by Curative Surgery in Patients With Esophageal Cancer

1区 · 医学

Article

作者: Hawle, Hanne ; Hayoz, Stefanie ; Kettelhack, Christoph ; Walz, Martin K ; Steffen, Thomas ; Alesina, Piero ; Furrer, Markus ; Grieder, Felix ; Schmidt, Sven ; Gérard, Marie-Aline ; Knoefel, Wolfram-Trudo ; Köigsrainer, Alfred ; Piessen, Guillaume ; Gloor, Beat ; Ruhstaller, Thomas ; Bartsch, Detlef ; Függer, Reinhold ; Schäfer, Markus ; Marti, Walter R ; Schnider, Annelies ; von Holzen, Urs

Objective:To assess the impact of surgical technique in regard to morbidity and mortality after neoadjuvant treatment for esophageal cancer.Background:The SAKK trial 75/08 was a multicenter phase III trial (NCT01107639) comparing induction chemotherapy followed by chemoradiation and surgery in patients with locally advanced esophageal cancer.Methods:Patients in the control arm received induction chemotherapy with cisplatin and docetaxel, followed by concomitant chemoradiation therapy with cisplatin, docetaxel, and 45Gy. In the experimental arm, the same regimen was used with addition of cetuximab. After completion of neoadjuvant treatment, patients underwent esophagectomy. The experimental arm received adjuvant cetuximab. Surgical outcomes and complications were prospectively recorded and analyzed.Results:Total of 259 patients underwent esophagectomy. Overall complication rate was 56% and reoperation rate was 15% with no difference in complication rates for transthoracic versus transhiatal resections (56% vs 54%, P = 0.77), nor for video assisted thoracic surgeries (VATS) versus open transthoracic resections (67% vs 55%, P = 0.32). There was a trend to higher overall complication rates in squamous cell carcinoma versus adenocarcinoma (65% vs 51%, P = 0.035), and a significant difference in ARDS in squamous cell carcinoma with 14% versus 2% in adenocarcinoma (P = 0.0002). For patients with involved lymph nodes, a lymph node ratio of ≥0.1 was an independent predictor of PFS (HR 2.5, P = 0.01) and OS (HR 2.2, P = 0.03).Conclusions:This trial showed no difference in surgical complication rates between transthoracic and transhiatal resections. For patients with involved lymph nodes, lymph node ratio was an independent predictor of progression free survival and overall survival.

2021-11-05·Blood

Treatment-Free Remission (TFR) after Two Different Durations of Nilotinib Consolidation in Patients with Chronic Myeloid Leukemia (CML) Previously Treated with Imatinib: Enestpath Study Results

作者: Sportoletti, Paolo ; Charbonnier, Aude ; Stenke, Leif ; Kyrcz-Krzemien, Slawomira ; Angona, Anna ; Weltermann, Ansgar ; Mayer, Jiří ; Di Caprio, Luigi ; Rea, Delphine ; Illes, Arpad ; Shah, Seema ; Marinakis, Theodoros ; Kiani, Alexander ; Baccarani, Michele ; Supekar, Sharon

AbstractBackgroundTFR following cessation of tyrosine kinase inhibitor (TKI) therapy is increasingly regarded as a feasible objective for many patients (pts) with CML in chronic phase (CML-CP) who achieve a sustained deep molecular response (DMR). In Evaluating Nilotinib Efficacy and Safety in clinical Trials (ENEST)-complete molecular response (ENESTcmr), pts unable to achieve DMR on imatinib (IM) were able to reach deeper levels of MR by switching to nilotinib (NIL) 400 mg twice daily (BID) vs continuing IM (Hughes et al. 2017). Recent long-term analysis from ENESTop illustrated the durability and safety of TFR for pts who achieved sustained DMR only after switching from IM to NIL 400 mg (Hughes et al. 2021). European LeukemiaNet guidelines allow discontinuation of TKI therapy following >2 years of DMR (MR 4.0 or better) (Hochhaus et al. 2020). However, the optimal duration of NIL consolidation (CONS) to increase the chances for successful TFR is not yet known.ObjectivesThe ENESTPath study was designed to evaluate the impact of 12 or 24 months (mos) of NIL 300 mg BID CONS, on the TFR rate in pts who had not achieved sustained DMR with IM.MethodsENESTPath (NCT01743989) is a prospective, randomized, open-label, two-arm phase 3 study that enrolled pts with CML-CP who achieved a complete cytogenetic response (CCyR), but not MR 4.0, after ≥24 mos of IM. After enrollment, pts received NIL 300 mg BID for 12 mos each of induction (IND) and CONS. Pts with sustained DMR for at least the last 12 mos (≥MR 4.0; BCR-ABL1IS ≤0.01% in 4 of the 5 preceding quarterly assessments and ≥MR 4.0 in the last assessment) were randomized (1:1) either to enter the TFR phase (Arm 1) or to continue NIL for an additional 12 mos CONS, before entering TFR (Arm 2) if eligibility criteria were still met, resulting in a 36- or 24- mos TFR phase, respectively (Figure 1). The primary endpoint was the number of pts who remained in TFR (≥MR 4.0) without molecular relapse 12 mos after entering TFR. Molecular relapse was defined as loss of major molecular response (loss of MMR, BCR-ABL1IS >0.1%) or the confirmed loss of MR 4.0 (3 tests <MR 4.0 assessed at 3 consecutive visits).ResultsOverall, 620 pts were enrolled. In the full analysis set (FAS, N=619), 238 pts were randomized after 24 mos of NIL, 381 patients were not randomized and followed for survival, and one pt was excluded from FAS due to major protocol deviation. Baseline characteristics were well balanced between Arm 1 (N=120) and Arm 2 (N=118): 49.5 and 49.0 years median age; 60.0% and 58.5% male; 56.11 vs 57.97 mos median time since initial diagnosis; 54.08 vs 57.99 mos median prior exposure to IM, respectively. The number of pts in the FAS entering TFR was 119 in Arm 1 and 104 in Arm 2. There was no significant difference in the primary endpoint of MR 4.0 rate at 12 mos of TFR between arms (Arm 1, 31.9% [95% CI: 23.7 - 41.1]; Arm 2, 37.5% [95% CI: 28.2 - 47.5]; P=0.383) (Table 1). Median time to treatment-free survival event (TFS; defined as loss of MMR, confirmed loss of MR 4.0, re-start of NIL for any reason, progression to accelerated phase/blast crisis, or death from any cause) was 4.1 (95% CI: 3.7 - 5.5) mos in Arm 1 and 4.2 (95% CI: 3.7 - 19.7) in Arm 2 (Figure 2). Among the 129 pts who relapsed during TFR and were re-treated with NIL, the majority regained MMR and MR 4.0 by 3 mos (Table 2). In the 619 pts who received NIL during IND/CONS, the raw cumulative rate of MR 4.0 and MR 4.5 was 64.3% and 36.8% by 12 mos and 72.4% and 48.0% by 24 mos, respectively. The proportion of pts who achieved MR 4.0 and MR 4.5 was 48.0% and 25.0% at 12 mos, and 44.1% and 24.9% at 24 mos, respectively. During IND/CONS before randomization, 87.7% (543/619) pts experienced an adverse event (AE), 18.1% (112/619) serious AEs (SAEs), 9.7% (60/619) cardiovascular AEs, and 12.1% (75/619) discontinued study treatment due to AEs. In the TFR phase, 63.2% (141/223) pts experienced AEs, and 6.7% (15/223) pts SAEs (Table 3); and three patients had SAEs suspected to be related to study drug (all in Arm 1): one cerebrovascular accident, one peripheral artery stenosis, and one Grade 3/4 myocardial infarction.ConclusionsENESTPath results suggest there is no significant incremental benefit in terms of TFR success from an additional year of NIL CONS for pts with CML-CP who achieved sustained DMR after 2 years on NIL following a switch from IM. The efficacy of NIL at a dose of 300 mg BID in achieving MR in pts unable to reach sustained DMR with first-line IM for ≥24 mos was confirmed. No new safety signals were observed.Figure 1 Figure 1.DisclosuresRea: Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees. Sportoletti: AstraZeneca: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria. Mayer: Principia: Research Funding. Illes: Novartis, Janssen, Pfizer, Roche: Other: Travel, Accommodations, Expenses; Takeda, Seattle Genetics: Research Funding; Janssen, Celgene, Novartis, Pfizer, Takeda, Roche: Consultancy. Kiani: Novartis Pharma GmbH: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Charbonnier: Pfizer: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Marinakis: Novartis: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria. Stenke: Incyte: Membership on an entity's Board of Directors or advisory committees. Shah: Cognizant technology Solutions: Current Employment. Supekar: Novartis Farma: Current Employment. Di Caprio: Novartis Pharma: Current Employment. Baccarani: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees.

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100 项与 Krankenhaus der Elisabethinen Linz GmbH 相关的转化医学

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