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1.
J Clin Gastroenterol ; 50(8): 649-57, 2016 09.
Article in English | MEDLINE | ID: mdl-27332745

ABSTRACT

GOALS: To examine the utility of integrated molecular pathology (IMP) in managing surveillance of pancreatic cysts based on outcomes and analysis of false negatives (FNs) from a previously published cohort (n=492). BACKGROUND: In endoscopic ultrasound with fine-needle aspiration (EUS-FNA) of cyst fluid lacking malignant cytology, IMP demonstrated better risk stratification for malignancy at approximately 3 years' follow-up than International Consensus Guideline (Fukuoka) 2012 management recommendations in such cases. STUDY: Patient outcomes and clinical features of Fukuoka and IMP FN cases were reviewed. Practical guidance for appropriate surveillance intervals and surgery decisions using IMP were derived from follow-up data, considering EUS-FNA sampling limitations and high-risk clinical circumstances observed. Surveillance intervals for patients based on IMP predictive value were compared with those of Fukuoka. RESULTS: Outcomes at follow-up for IMP low-risk diagnoses supported surveillance every 2 to 3 years, independent of cyst size, when EUS-FNA sampling limitations or high-risk clinical circumstances were absent. In 10 of 11 patients with FN IMP diagnoses (2% of cohort), EUS-FNA sampling limitations existed; Fukuoka identified high risk in 9 of 11 cases. In 4 of 6 FN cases by Fukuoka (1% of cohort), IMP identified high risk. Overall, 55% of cases had possible sampling limitations and 37% had high-risk clinical circumstances. Outcomes support more cautious management in such cases when using IMP. CONCLUSIONS: Adjunct use of IMP can provide evidence for relaxed surveillance of patients with benign cysts that meet Fukuoka criteria for closer observation or surgery. Although infrequent, FN results with IMP can be associated with EUS-FNA sampling limitations or high-risk clinical circumstances.


Subject(s)
Endoscopic Ultrasound-Guided Fine Needle Aspiration , Molecular Diagnostic Techniques , Pancreatic Cyst/diagnosis , Pancreatic Neoplasms/diagnosis , Aged , Aged, 80 and over , Cohort Studies , Cyst Fluid/metabolism , False Negative Reactions , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pancreatic Cyst/pathology , Predictive Value of Tests , Retrospective Studies
2.
Endoscopy ; 47(2): 136-42, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25314329

ABSTRACT

BACKGROUND AND STUDY AIMS: Current diagnostic testing is inadequate to determine the malignant potential of pancreatic cysts, resulting in overcautious patient management. Integrated molecular pathology (IMP) testing combines molecular analysis with first-line test results (cytology, imaging, and fluid chemistry) to assess the malignant potential of pancreatic cysts. This multicenter study aimed to determine the diagnostic accuracy of IMP for pancreatic adenocarcinoma, and the utility of IMP testing under current guideline recommendations for managing pancreatic cysts. PATIENTS AND METHODS: Patients who had undergone previous IMP testing as prescribed by their physician and for whom clinical outcomes were available from retrospective record review were included (n = 492). Performance was determined by correlation between clinical outcome and previous IMP diagnosis ("benign"/"statistically indolent" vs. "statistically higher risk [SHR]"/ "aggressive") or an International Consensus Guideline (Sendai 2012) criteria model for "surveillance" vs. "surgery." The Cox proportional hazards model determined hazard ratios for malignancy. RESULTS: Benign and statistically indolent IMP diagnoses had a 97 % probability of benign follow-up for up to 7 years and 8 months from initial IMP testing. SHR and aggressive diagnoses had relative hazard ratios for malignancy of 30.8 and 76.3, respectively (both P < 0.0001). Sendai surveillance criteria had a 97 % probability of benign follow-up for up to 7 years and 8 months, but for surgical criteria the hazard ratio was only 9.0 (P < 0.0001). In patients who met Sendai surgical criteria, benign and statistically indolent IMP diagnoses had a > 93 % probability of benign follow-up, with relative hazard ratios for SHR and aggressive IMP diagnoses of 16.1 and 50.2, respectively (both P < 0.0001). CONCLUSION: IMP more accurately determined the malignant potential of pancreatic cysts than a Sendai 2012 guideline management criteria model. IMP may improve patient management by justifying more relaxed observation in patients meeting Sendai surveillance criteria. IMP can more accurately differentiate between the need for surveillance or surgery in patients meeting Sendai surgical criteria.


Subject(s)
Adenocarcinoma/pathology , Cyst Fluid/chemistry , Pancreatic Cyst/chemistry , Pancreatic Cyst/pathology , Pancreatic Neoplasms/pathology , Cell Transformation, Neoplastic , Female , Follow-Up Studies , Humans , Likelihood Functions , Male , Middle Aged , Pancreatic Cyst/surgery , Predictive Value of Tests , Proportional Hazards Models , Retrospective Studies , Risk Assessment/methods
3.
Gastrointest Endosc ; 77(6): 932-6, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23531424

ABSTRACT

BACKGROUND: Preprocedural dietary restrictions have been identified as a common reason potential candidates for colorectal cancer screening do not undergo colonoscopy as recommended. OBJECTIVE: To study whether a low-residue diet impacts bowel preparation with oral sulfate solution. DESIGN: Endoscopist blinded, prospective, randomized controlled trial. SETTING: Community-based outpatient ambulatory surgical center. PATIENTS: Patients scheduled for outpatient colonoscopy. INTERVENTIONS: Subjects were randomized to ingest either a low-residue diet of specified foods for breakfast, lunch, and snack or a clear liquid diet the day before the colonoscopy. MAIN OUTCOME MEASUREMENTS: The quality of the bowel preparation was assessed using the Boston Bowel Preparation Scale. Subject satisfaction with bowel preparation, diet, and severity of side effects was measured by a visual analog scale. RESULTS: Two hundred thirty subjects were recruited (114 clear liquid and 116 low residue). Mean preparation scores were not statistically different in either their segmental scores or total score. Subjects in the low-residue arm reported significantly higher satisfaction with bowel preparation medication, diet, and entire preparation process. Observed rates of side effects were low, and there was no statistical difference between the two groups. The rate of procedural cancellation was significantly higher in the clear liquid group compared with the low-residue group (20% vs 9%, P = .03). LIMITATIONS: Single-center study. CONCLUSIONS: A low-residue diet did not impair the quality of bowel preparation achieved with split-dose oral sulfate solution but did improve patient satisfaction.


Subject(s)
Cathartics/therapeutic use , Colonoscopy/methods , Diet , Patient Satisfaction , Aged , Female , Humans , Male , Middle Aged
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