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Cost-Benefit Analysis and Resource Implications of Endoscopic Ultrasound-Guided Confocal Endomicroscopy in Pancreatic Cysts

Published:October 26, 2021DOI:https://doi.org/10.1016/j.tige.2021.10.002

      Abstract

      Background and Aims

      EUS-guided needle-based confocal laser endomicroscopy (nCLE) improves the diagnostic accuracy of pancreatic cystic lesions (PCLs) but concerns regarding its expense have limited widespread adoption of this technology. We conducted a cost-benefit analysis to assess the healthcare resource implications of adding EUS-nCLE to the standard of care (SOC) management of PCLs.

      Methods

      A post-hoc analysis of a prospective study (2015-2018) evaluating EUS-nCLE for the diagnosis of PCLs was performed. The SOC diagnosis was based on clinical history, PCL morphology, and cyst fluid analysis. A minimum of 5-years surveillance was included, the cost of EUS and MRI/MRCP was derived from institutional billing data (US$), and the total hospital costs (adjusted for inflation) for pancreatic operations were derived from the National (US) Readmission Database.

      Results

      A reference diagnosis was available in 93 subjects (mean cyst size = 36.4 ± 15.7 mm; surgical histopathology, n = 67 and diagnostic molecular markers in cyst fluid, n = 26). SOC and nCLE were discordant in 13 (14%) subjects. The addition of nCLE led to 11 subjects being clinically down-staged from mucinous to non-mucinous not warranting surgery (total cost savings = $1,080,418), 1 subject upstaged from non-mucinous to mucinous, warranting surgical resection (cost savings of 5-years surveillance: $46,200), and 1 subject incorrectly classified as non-mucinous (cost excess of 5-years surveillance: $46,200). Overall, the addition of nCLE led to a net savings of $ 442,438 (mean: $ 4757.40/patient) for this cohort.

      Conclusion

      EUS-nCLE is potentially cost-beneficial in the management of PCLs (≥3 cm) by preventing at least one unnecessary pancreatic surgery for every 10 subjects undergoing evaluation by current practices. ClinicalTrials.gov number: NCT02516488.
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      References

        • Moris M
        • Bridges MD
        • Pooley RA
        • et al.
        Association between advances in high-resolution cross-section imaging technologies and increase in prevalence of pancreatic cysts from 2005 to 2014.
        Clin Gastroenterol Hepatol. 2016; 14 (e3): 585-593
        • Zanini N
        • Giordano M
        • Smerieri E
        • et al.
        Estimation of the prevalence of asymptomatic pancreatic cysts in the population of San Marino.
        Pancreatology. 2015; 15: 417-422
        • Tanaka M.
        Clinical management and surgical decision-making of IPMN of the pancreas.
        Methods Mol Biol. 2019; 1882: 9-22
        • Valsangkar NP
        • Morales-Oyarvide V
        • Thayer SP
        • et al.
        851 resected cystic tumors of the pancreas: a 33-year experience at the Massachusetts General Hospital.
        Surgery. 2012; 152: S4-12
        • Gaujoux S
        • Brennan MF
        • Gonen M
        • et al.
        Cystic lesions of the pancreas: changes in the presentation and management of 1,424 patients at a single institution over a 15-year time period.
        J Am Coll Surg. 2011; 212 (discussion 600-3): 590-600
        • Krishna SG
        • Brugge WR
        • Dewitt JM
        • et al.
        Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos).
        Gastrointest Endosc. 2017; 86 (e2): 644-654
        • Napoleon B
        • Lemaistre AI
        • Pujol B
        • et al.
        A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy.
        Endoscopy. 2015; 47: 26-32
        • Napoleon B
        • Lemaistre AI
        • Pujol B
        • et al.
        In vivo characterization of pancreatic cystic lesions by needle-based confocal laser endomicroscopy (nCLE): proposition of a comprehensive nCLE classification confirmed by an external retrospective evaluation.
        Surg Endosc. 2016; 30: 2603-2612
        • Napoleon B
        • Palazzo M
        • Lemaistre AI
        • et al.
        Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis.
        Endoscopy. 2019; 51: 825-835
        • Konda VJ
        • Meining A
        • Jamil LH
        • et al.
        A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic guidance.
        Endoscopy. 2013; 45: 1006-1013
        • Nakai Y
        • Iwashita T
        • Park DH
        • et al.
        Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study.
        Gastrointest Endosc. 2015; 81: 1204-1214
        • Krishna SG
        • Hart PA
        • Malli A
        • et al.
        Endoscopic ultrasound-guided confocal laser endomicroscopy increases accuracy of differentiation of pancreatic cystic lesions.
        Clin Gastroenterol Hepatol. 2020; 18 (e6): 432-440
      1. Bosman F, Carneiro F, Hruban R, et al. WHO classification of tumours of the digestive system, fourth edition. France: IARC, 2010 [cited 2020 July 7]. Available from http://www.ncbi.nlm.nih.gov/nlmcatalog/101553728

        • Singhi AD
        • Nikiforova MN
        • Fasanella KE
        • et al.
        Preoperative GNAS and KRAS testing in the diagnosis of pancreatic mucinous cysts.
        Clin Cancer Res. 2014; 20: 4381-4389
        • Singhi AD
        • McGrath K
        • Brand RE
        • et al.
        Preoperative next-generation sequencing of pancreatic cyst fluid is highly accurate in cyst classification and detection of advanced neoplasia.
        Gut. Volume. 2018; 67: 2131-2141
        • Nikiforova MN
        • Khalid A
        • Fasanella KE
        • et al.
        Integration of KRAS testing in the diagnosis of pancreatic cystic lesions: a clinical experience of 618 pancreatic cysts.
        Mod Pathol. 2013; 26: 1478-1487
        • Springer S
        • Wang Y
        • Dal Molin M
        • et al.
        A combination of molecular markers and clinical features improve the classification of pancreatic cysts.
        Gastroenterology. 2015; 149: 1501-1510
        • Bellizzi AM
        • Stelow EB.
        Pancreatic cytopathology: a practical approach and review.
        Arch Pathol Lab Med. 2009; 133: 388-404
        • Sahani DV
        • Kadavigere R
        • Saokar A
        • et al.
        Cystic pancreatic lesions: a simple imaging-based classification system for guiding management.
        Radiographics. 2005; 25: 1471-1484
        • Brugge WR.
        Diagnosis and management of cystic lesions of the pancreas.
        J Gastrointest Oncol. 2015; 6: 375-388
        • Wang Y
        • Chai N
        • Feng J
        • et al.
        A prospective study of endoscopic ultrasonography features, cyst fluid carcinoembryonic antigen, and fluid cytology for the differentiation of small pancreatic cystic neoplasms.
        Endosc Ultrasound. 2018; 7: 335-342
        • Tanaka M
        • Fernandez-Del Castillo C
        • Kamisawa T
        • et al.
        Revisions of international consensus Fukuoka guidelines for the management of IPMN of the pancreas.
        Pancreatology. 2017; 17: 738-753
        • Maggi G
        • Guarneri G
        • Gasparini G
        • et al.
        Pancreatic cystic neoplasms: what is the most cost-effective follow-up strategy?.
        Endosc Ultrasound. 2018; 7: 319-322
        • Nguyen AK
        • Girgis A
        • Tekeste T
        • et al.
        Effect of a region-wide incorporation of an algorithm based on the 2012 international consensus guideline on the practice pattern for the management of pancreatic cystic neoplasms in an integrated health system.
        World J Clin Cases. 2018; 6: 624-631
        • Pergolini I
        • Sahora K
        • Ferrone CR
        • et al.
        Long-term risk of pancreatic malignancy in patients with branch duct intraductal papillary mucinous neoplasm in a referral center.
        Gastroenterology. 2017; 153 (e1): 1284-1294
      2. NRD Overview. https://www.hcup-us.ahrq.gov/nrdoverview.jsp. Volume 2018.

        • Newcomer KE
        • Hatry HP
        • Wholey JS.
        Cost-effectiveness and cost-benefit analysis.
        Handb Pract Prog Eval. 2015; 636: 493-530
        • Johannesson M.
        The relationship between cost-effectiveness analysis and cost-benefit analysis.
        Soc Sci Med. 1995; 41: 483-489
        • Udvarhelyi IS
        • Colditz GA
        • Rai A
        • et al.
        Cost-effectiveness and cost-benefit analyses in the medical literature: are the methods being used correctly?.
        Ann Intern Med. 1992; 116: 238-244
        • Palazzo M
        • Sauvanet A
        • Gincul R
        • et al.
        Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions.
        Surg Endosc. 2020; 34: 2532-2540
        • Le Pen C
        • Palazzo L
        • Napoleon B
        A health economic evaluation of needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cysts.
        Endosc Int Open. 2017; 5: E987-E995
        • Das A
        • Brugge W
        • Mishra G
        • et al.
        Managing incidental pancreatic cystic neoplasms with integrated molecular pathology is a cost-effective strategy.
        Endosc Int Open. 2015; 3: E479-E486
        • Das A
        • Ngamruengphong S
        • Nagendra S
        • et al.
        Asymptomatic pancreatic cystic neoplasm: a cost-effectiveness analysis of different strategies of management.
        Gastrointest Endosc. 2009; 70 (e6): 690-699
        • Napoleon B
        • Krishna SG
        • Marco B
        • et al.
        Confocal endomicroscopy for evaluation of pancreatic cystic lesions: a systematic review and international Delphi consensus report.
        Endosc Int Open. 2020; 8: E1566-E1581
        • Konjeti VR
        • McCarty TR
        • Rustagi T.
        Needle-based Confocal Laser Endomicroscopy (nCLE) for evaluation of pancreatic cystic lesions: a systematic review and meta-analysis.
        J Clin Gastroenterol. 2020; https://doi.org/10.1097/MCG.0000000000001468
        • Krishna SG
        • Hart PA
        • DeWitt JM
        • et al.
        EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video).
        Gastrointest Endosc. 2020; 91 (e5): 551-563
        • Machicado JD
        • Chao WL
        • Carlyn DE
        • et al.
        High performance in risk stratification of intraductal papillary mucinous neoplasms by confocal laser endomicroscopy image analysis with convolutional neural networks (with video).
        Gastrointest Endosc. 2021; 94: 78-87.e2
        • Scheiman JM
        • Hwang JH
        • Moayyedi P.
        American Gastroenterological Association technical review on the diagnosis and management of asymptomatic neoplastic pancreatic cysts.
        Gastroenterology. 2015; 148 (e22): 824-848
        • Sharib JM
        • Fonseca AL
        • Swords DS
        • et al.
        Surgical overtreatment of pancreatic intraductal papillary mucinous neoplasms: do the 2017 International Consensus Guidelines improve clinical decision making?.
        Surgery. 2018; 164: 1178-1184