Browsing by Author "Costamagna, Guido"

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    Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial
    (Elsevier, 2019) Seo, Dong Wan; Sherman, Stuart; Dua, Kulwinder S.; Slivka, Adam; Roy, Andre; Costamagna, Guido; Deviere, Jacques; Peetermans, Joyce; Rousseau, Matthew; Nakai, Yousuke; Isayama, Hiroyuki; Kozarek, Richard; Medicine, School of Medicine
    Background and Aims Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. Methods Patients with pancreatic cancer and planned NATx needing treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMS versus UCSEMS. Primary endpoint was sustained biliary drainage, defined as absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery (CIS) or 1 year. Results The intent-to-treat population had 119 patients (59 FCSEMS, 60 UCSEMS). Sustained biliary drainage was equally successful with FCSEMS and UCSEMS (72.2% vs 72.9%, noninferiority P=0.01). Reasons for FCSEMS and UCSEMS failure differed significantly between groups and included tumor ingrowth in 0 versus 16.7%, P<0.01, and stent migration in 6.8% vs. 0, P=0.03, respectively. Serious adverse event rates related to stent placement were insignificantly different in both groups (23.7% (14/59) vs 20.0% (12/60), P=0.66), as were acute cholecystitis rates when gallbladder in situ (9.3% (4/43) vs 4.8% (2/42), P=0.68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4 cm stent length and presence of gallbladder. Conclusion FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in pancreatic cancer patients receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder.
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    Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial
    (Elsevier, 2023) Sherman, Stuart; Kozarek, Richard A.; Costamagna, Guido; Reddy, Nageshwar; Tarnasky, Paul; Shah, Raj J.; Slivka, Adam; Fogel, Evan; Watkins, James; Delhaye, Myriam; Irani, Shayan S.; Tringali, Andrea; Lakhtakia, Sundeep; Kedia, Prashant; Edmundowicz, Steven; Peetermans, Joyce A.; Rousseau, Matthew J.; Devière, Jacques; Pancreatic SEMS in Chronic Pancreatitis Study Group; Medicine, School of Medicine
    Background and aims: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. Methods: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection.