Browsing by Author "Fockens, Paul"

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    EUS-derived criteria for distinguishing benign from malignant metastatic solid hepatic masses
    (Elsevier, 2015-05) Fujii-Lau, Larissa L.; Abu Dayyeh, Barham K.; Bruno, Marco J.; Chang, Kenneth J.; DeWitt, John M.; Fockens, Paul; Forcione, David; Napoleon, Bertrand; Palazzo, Laurent; Topazian, Mark D.; Wiersema, Maurits J.; Chak, Amitabh; Clain, Jonathan E.; Faigel, Douglas O.; Gleeson, Ferga C.; Hawes, Robert; Iyer, Prasad G.; Rajan, Elizabeth; Stevens, Tyler; Wallace, Michael B.; Wang, Kenneth K.; Levy, Michael J.; Medicine, School of Medicine
    Background Detection of hepatic metastases during EUS is an important component of tumor staging. Objective To describe our experience with EUS-guided FNA (EUS-FNA) of solid hepatic masses and derive and validate criteria to help distinguish between benign and malignant hepatic masses. Design Retrospective study, survey. Setting Single, tertiary-care referral center. Patients Medical records were reviewed for all patients undergoing EUS-FNA of solid hepatic masses over a 12-year period. Interventions EUS-FNA of solid hepatic masses. Main Outcome Measurements Masses were deemed benign or malignant according to predetermined criteria. EUS images from 200 patients were used to create derivation and validation cohorts of 100 cases each, matched by cytopathologic diagnosis. Ten expert endosonographers blindly rated 15 initial endosonographic features of each of the 100 images in the derivation cohort. These data were used to derive an EUS scoring system that was then validated by using the validation cohort by the expert endosonographer with the highest diagnostic accuracy. Results A total of 332 patients underwent EUS-FNA of a hepatic mass. Interobserver agreement regarding the initial endosonographic features among the expert endosonographers was fair to moderate, with a mean diagnostic accuracy of 73% (standard deviation 5.6). A scoring system incorporating 7 EUS features was developed to distinguish benign from malignant hepatic masses by using the derivation cohort with an area under the receiver operating curve (AUC) of 0.92; when applied to the validation cohort, performance was similar (AUC 0.86). The combined positive predictive value of both cohorts was 88%. Limitations Single center, retrospective, only one expert endosonographer deriving and validating the EUS criteria. Conclusion An EUS scoring system was developed that helps distinguish benign from malignant hepatic masses. Further study is required to determine the impact of these EUS criteria among endosonographers of all experience.
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    Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease
    (Springer Verlag, 2010-03-03) Fockens, Paul; Cohen, Lawrence; Edmundowicz, Steven A.; Binmoeller, Kenneth; Rothstein, Richard I.; Smith, Daniel; Lin, Edward; Nickl, Nicholas; Overholt, Bergein; Kahrilas, Peter J.; Vakil, Nimish; Aziz Hassan, Ayman M. Abdel; Lehman, Glen A.; Medicine, School of Medicine
    Background This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). Methods A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was <4) 6 months after the GK procedure compared with baseline.Results A planned interim analysis was performed after 143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients), and the GK study was terminated early due to lack of compelling efficacy data. Four reported serious adverse events had occurred (2 perforations, 1 pulmonary infiltrate related to a perforation, and 1 severe chest pain) at termination of the study with no mortality or long-term sequelae. Heartburn symptoms had improved significantly at 6 months compared with baseline in the GK group (p < 0.0001) and the sham group (p < 0.0001), but no significant between-group difference in improvement was observed (p = 0.146). Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27). Conclusions The GK procedure was associated with some serious but infrequent complications. No statistically significant difference in outcomes was observed between the treatment and control groups at 6 months compared with baseline.
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    When and How To Use Endoscopic Tattooing in the Colon: An International Delphi Agreement
    (Elsevier, 2021) Medina-Prado, Lucía; Hassan, Cesare; Dekker, Evelien; Bisschops, Raf; Alfieri, Sergio; Bhandari, Pradeep; Bourke, Michael J.; Bravo, Raquel; Bustamante-Balen, Marco; Dominitz, Jason; Ferlitsch, Monika; Fockens, Paul; van Leerdam, Monique; Lieberman, David; Herráiz, Maite; Kahi, Charles; Kaminski, Michal; Matsuda, Takahisa; Moss, Alan; Pellisé, Maria; Pohl, Heiko; Rees, Colin; Rex, Douglas K.; Romero-Simó, Manuel; Rutter, Matthew D.; Sharma, Prateek; Shaukat, Aasma; Thomas-Gibson, Siwan; Valori, Roland; Jover, Rodrigo; Medicine, School of Medicine
    Background & Aims There is a lack of clinical studies to establish indications and methodology for tattooing, therefore technique and practice of tattooing is very variable. We aimed to establish a consensus on the indications and appropriate techniques for colonic tattoo through a modified Delphi process. Methods The baseline questionnaire was classified into 3 areas: where tattooing should not be used (1 domain, 6 questions), where tattooing should be used (4 domains, 20 questions), and how to perform tattooing (1 domain 20 questions). A total of 29 experts participated in the 3 rounds of the Delphi process. Results A total of 15 statements were approved. The statements that achieved the highest agreement were as follows: tattooing should always be used after endoscopic resection of a lesion with suspicion of submucosal invasion (agreement score, 4.59; degree of consensus, 97%). For a colorectal lesion that is left in situ but considered suitable for endoscopic resection, tattooing may be used if the lesion is considered difficult to detect at a subsequent endoscopy (agreement score, 4.62; degree of consensus, 100%). A tattoo should never be injected directly into or underneath a lesion that might be removed endoscopically at a later point in time (agreement score, 4.79; degree of consensus, 97%). Details of the tattoo injection should be stated clearly in the endoscopy report (agreement score, 4.76; degree of consensus, 100%). Conclusions This expert consensus has developed different statements about where tattooing should not be used, when it should be used, and how that should be done.