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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/Book"><div class="meta-content fm-sec"><div class="iconblock whole_rhythm clearfix no_top_margin"><a href="http://www.nap.edu/" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng231er13-lrg.png" alt="Cover of Evidence review for anti-reflux surgery to induce remission of disease or prevent recurrence" /></a><div class="icnblk_cntnt"><h1 id="_NBK595315_"><span itemprop="name">Evidence review for anti-reflux surgery to induce remission of disease or prevent recurrence</span></h1><div class="subtitle">Barrett’s oesophagus and stage 1 oesophageal adenocarcinoma</div><p><b>Evidence review M</b></p><p><i>NICE Guideline, No. 231</i></p><div class="half_rhythm">London: <a href="http://www.nap.edu/" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2023 Feb</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5019-5</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div></div></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="niceng231er13.s1"><h2 id="_niceng231er13_s1_">1. Anti-reflux surgery to induce remission of disease or prevent recurrence</h2><div id="niceng231er13.s1.1"><h3>1.1. Review question</h3><p>For adults with Barrett’s oesophagus or stage 1 adenocarcinoma, what is the clinical and cost effectiveness of anti-reflux surgery to induce remission of disease or prevent recurrence?</p><div id="niceng231er13.s1.1.1"><h4>1.1.1. Introduction</h4><p>In adults with Barrett’s oesophagus, anti-reflux surgery (laparoscopic fundoplication) can be used to try to induce remission of disease and prevent progression to cancer. This review aims to assess how clinically and cost effective anti-reflux surgery is to induce remission of disease and prevent recurrence.</p></div><div id="niceng231er13.s1.1.2"><h4>1.1.2. Summary of the protocol</h4><p>For full details see the review protocol in <a href="#niceng231er13.appa">Appendix A</a>.</p></div><div id="niceng231er13.s1.1.3"><h4>1.1.3. Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng231er13.appa">appendix A</a> and the <a href="/books/NBK595315/bin/methods-pdf-11371337245.pdf">methods</a> document.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng231er13.s1.1.4"><h4>1.1.4. Effectiveness evidence</h4><div id="niceng231er13.s1.1.4.1"><h5>1.1.4.1. Included studies</h5><p>One observational study was included in the review<a class="bk_pop" href="#niceng231er13.s1.1.ref2"><sup>2</sup></a>. This is summarised in <a class="figpopup" href="/books/NBK595315/table/niceng231er13.tab2/?report=objectonly" target="object" rid-figpopup="figniceng231er13tab2" rid-ob="figobniceng231er13tab2">Table 2</a> below. The study aimed to assess the effects of Nissen fundoplication in patients who had complete eradication of metaplastic and dysplastic Barrett’s oesophagus after Endoscopic radiofrequency ablation (RFA).</p><p>This was a prospective clinical study comparing daily PPI (esomeprazole 40 mg/day) with laparoscopic Nissen fundoplication (LNF) after or synchronous with RFA procedure. (<a class="figpopup" href="/books/NBK595315/table/niceng231er13.tab3/?report=objectonly" target="object" rid-figpopup="figniceng231er13tab3" rid-ob="figobniceng231er13tab3">Table 3</a>).</p><p>See also the study selection flow chart in <a href="#niceng231er13.appc">Appendix C</a>, study evidence tables in <a href="#niceng231er13.appd">Appendix D</a>, forest plots in <a href="#niceng231er13.appe">Appendix E</a> and GRADE tables in <a href="#niceng231er13.appf">Appendix F</a>.</p></div><div id="niceng231er13.s1.1.4.2"><h5>1.1.4.2. Excluded studies</h5><p>See the excluded studies list in <a href="#niceng231er13.apph">Appendix H</a>.</p></div></div><div id="niceng231er13.s1.1.5"><h4>1.1.5. Summary of studies included in the effectiveness evidence</h4><p>See <a href="#niceng231er13.appd">Appendix D</a> for full evidence tables.</p></div><div id="niceng231er13.s1.1.6"><h4>1.1.6. Summary of the effectiveness evidence</h4><p>See <a href="#niceng231er13.appf">Appendix F</a> for full GRADE</p></div><div id="niceng231er13.s1.1.7"><h4>1.1.7. Economic evidence</h4><div id="niceng231er13.s1.1.7.1"><h5>1.1.7.1. Included studies</h5><p>No health economic studies were included.</p></div><div id="niceng231er13.s1.1.7.2"><h5>1.1.7.2. Excluded studies</h5><p>No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#niceng231er13.appg">Appendix G</a>.</p></div></div><div id="niceng231er13.s1.1.8"><h4>1.1.8. Summary of included economic evidence</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng231er13.s1.1.9"><h4>1.1.9. Economic model</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng231er13.s1.1.10"><h4>1.1.10. Unit costs</h4><p>Relevant unit costs are provided below to aid consideration of cost effectiveness.</p></div><div id="niceng231er13.s1.1.11"><h4>1.1.11. The committee’s discussion and interpretation of the evidence</h4><div id="niceng231er13.s1.1.11.1"><h5>1.1.11.1. The outcomes that matter most</h5><p>The outcomes considered for this review were mortality (disease specific mortality, treatment related mortality and all cause), health related quality of life, progression of dysplasia, progression to cancer, recurrence of Barrett’s oesophagus/dysplasia/cancer, number of endoscopic treatments to achieve remission of Barrett’s, time duration of the endoscopic treatment and adverse events (such as bleeding, pain). For purposes of decision making, all outcomes were considered equally important and were therefore rated as critical by the committee.</p><p>Evidence was identified for the outcome of recurrence of Barrett’s oesophagus. No evidence for any other outcomes was identified.</p></div><div id="niceng231er13.s1.1.11.2"><h5>1.1.11.2. The quality of the evidence</h5><p>One observational study was identified comparing anti-reflux surgery with medical treatment (esomeprazole) as post radiofrequency ablation modality. The quality of the evidence was very low for both outcomes of recurrence of Barrett’s oesophagus recurrence of Barrett’s oesophagus in people with C length ≥ 4cm. The evidence was downgraded for imprecision in the effect estimates with the confidence intervals being very wide and very serious risk of bias due to potential selection bias as patients were divided into intervention groups on the basis of their preference after both interventions had been presented to them. No randomized controlled trials were identified relevant to the review protocol.</p></div><div id="niceng231er13.s1.1.11.3"><h5>1.1.11.3. Benefits and harms</h5><p>The evidence showed a clinically important benefit of anti-reflux surgery for recurrence of Barrett’s oesophagus in the overall study population and in a sub-group of people with C length ≥ 4cm. However, the committee had low confidence in the quality of the evidence as it came from an observational study with very wide confidence intervals and a very small number of participants. The committee agreed, patients who fail to respond to radiofrequency ablation can be referred for anti-reflux surgery. However, the committee also noted that very few patients are unresponsive to radiofrequency ablation, and in such cases other ablation therapies such as argon plasma coagulation (APC) could be considered instead of anti-reflux surgery as they are more likely to be beneficial. Due to the lack of sufficient evidence and because there was no consensus amongst the committee on the benefit of the intervention for this population they agreed to not make a recommendation for anti-reflux surgery to induce remission or prevent recurrence in people with stage 1 adenocarcinoma .The committee discussed making a research recommendation in people who do not achieve remission with RFA, but agreed that in current practice clinicians are more inclined towards other ablation modalities in patients who are unresponsive to RFA instead of anti-reflux surgery and anti-reflux surgery is not a priority area for further research.</p></div><div id="niceng231er13.s1.1.11.4"><h5>1.1.11.4. Cost effectiveness and resource use</h5><p>Surgery has a high up-front cost, but this could be potentially offset by improved health outcome and reduced use of medicine.</p><p>No economic evaluations were identified for this question. The unit cost of surgery was presented.</p><p>The clinical evidence showed a clinically important benefit with anti-reflux surgery versus no surgery in recurrence of Barrett’s oesophagus of a length ≥4cm. The committee decided that the quality of the evidence was not sufficient to inform the cost effectiveness of surgery. Therefore, it abstained from making any recommendation.</p></div></div><div id="niceng231er13.s1.1.12"><h4>1.1.12. Recommendations supported by this evidence review</h4><p>This evidence review supports recommendation 1.8.1.</p></div><div id="niceng231er13.s1.1.rl.r1"><h4>1.1.13. References</h4><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="niceng231er13.s1.1.ref1">National Institute for Health and Care Excellence. Developing NICE guidelines: the manual [updated January
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2022]. London. National Institute for Health and Care Excellence, 2014. Available from: <a href="http://www.nice.org.uk/article/PMG20/chapter/1%20Introduction%20and%20overview" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>.nice.org.uk<wbr style="display:inline-block"></wbr>/article/PMG20/chapter<wbr style="display:inline-block"></wbr>/1%20Introduction%20and%20overview</a></div></dd><dt>2.</dt><dd><div class="bk_ref" id="niceng231er13.s1.1.ref2">Skrobic
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O, Simic
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A, Radovanovic
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N, Ivanovic
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N, Micev
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M, Pesko
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P. Significance of Nissen fundoplication after endoscopic radiofrequency ablation of Barrett’s esophagus. Surgical Endoscopy. 2016; 30(9):3802–3807 [<a href="https://pubmed.ncbi.nlm.nih.gov/26659238" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26659238</span></a>]</div></dd></dl></div></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng231er13.appa"><h3>Appendix A. Review protocols</h3><p id="niceng231er13.appa.et1"><a href="/books/NBK595315/bin/niceng231er13-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for anti-reflux surgery to induce remission of disease or prevent recurrence</a><span class="small"> (PDF, 134K)</span></p><p id="niceng231er13.appa.et2"><a href="/books/NBK595315/bin/niceng231er13-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Health economic review protocol</a><span class="small"> (PDF, 130K)</span></p></div><div id="niceng231er13.appb"><h3>Appendix B. Literature search strategies</h3><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.<a class="bk_pop" href="#niceng231er13.s1.1.ref1"><sup>1</sup></a></p><p>For more information, please see the Methodology review published as part of the accompanying documents for this guideline.</p><p id="niceng231er13.appb.et1"><a href="/books/NBK595315/bin/niceng231er13-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.1. Clinical search literature search strategy</a><span class="small"> (PDF, 129K)</span></p><p id="niceng231er13.appb.et2"><a href="/books/NBK595315/bin/niceng231er13-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.2. Health Economics literature search strategy</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng231er13.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng231er13.appc.et1"><a href="/books/NBK595315/bin/niceng231er13-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 1. Flow chart of clinical study selection for the review of anti-reflux surgery for remission</a><span class="small"> (PDF, 98K)</span></p></div><div id="niceng231er13.appd"><h3>Appendix D. Effectiveness evidence</h3><p id="niceng231er13.appd.et1"><a href="/books/NBK595315/bin/niceng231er13-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (178K)</span></p></div><div id="niceng231er13.appe"><h3>Appendix E. Forest plots</h3><p id="niceng231er13.appe.et1"><a href="/books/NBK595315/bin/niceng231er13-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (116K)</span></p></div><div id="niceng231er13.appf"><h3>Appendix F. GRADE</h3><p id="niceng231er13.appf.et1"><a href="/books/NBK595315/bin/niceng231er13-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 7. Clinical evidence profile: Anti-reflux surgery with endoscopic treatment vs medical treatment</a><span class="small"> (PDF, 163K)</span></p></div><div id="niceng231er13.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng231er13.appg.et1"><a href="/books/NBK595315/bin/niceng231er13-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (161K)</span></p></div><div id="niceng231er13.apph"><h3>Appendix H. Excluded studies</h3><div id="niceng231er13.apph.s1"><h4>Clinical studies</h4><div id="niceng231er13.apph.tab1" class="table"><h3><span class="label">Table 8</span><span class="title">Studies excluded from the clinical review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595315/table/niceng231er13.apph.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng231er13.apph.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Reason for exclusion</th></tr></thead><tbody><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Ackroyd, R., Tam, W., Schoeman, M.
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et al. (2004) Prospective randomized controlled trial of argon plasma coagulation ablation vs. endoscopic surveillance of patients with Barrett’s esophagus after antireflux surgery. Gastrointestinal Endoscopy
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||
59(1): 1–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/14722539" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14722539</span></a>]
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</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Study does not contain an intervention relevant to this review protocol</p>
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<p>Comparing APC ablation with endoscopic surveillance</p>
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</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Faybush, E. M. and Sampliner, R. E. (2005) Randomized trials in the treatment of Barrett’s esophagus. Diseases of the Esophagus
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18(5): 291–7 [<a href="https://pubmed.ncbi.nlm.nih.gov/16197527" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16197527</span></a>]
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||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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||
<p>- Study does not contain an intervention relevant to this review protocol</p>
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||
<p>Systematic review comparing different treatment modalities not relevant to the review protocol</p>
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||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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||
Hubbard, N. and Velanovich, V. (2007) Endoscopic endoluminal radiofrequency ablation of Barrett’s esophagus in patients with fundoplications. Surgical Endoscopy
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||
21(4): 625–8 [<a href="https://pubmed.ncbi.nlm.nih.gov/17364152" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17364152</span></a>]
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</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>- Outcome not relevant to this review protocol</p>
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<p>Assessing GERD related outcomes</p>
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</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Li, Y. M., Li, L., Yu, C. H.
|
||
et al. (2008) A systematic review and meta-analysis of the treatment for Barrett’s esophagus. Digestive Diseases & Sciences
|
||
53(11): 2837–46 [<a href="https://pubmed.ncbi.nlm.nih.gov/18427992" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18427992</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Study does not contain an intervention relevant to this review protocol</p>
|
||
<p>Comparing different treatment modalities not relevant to this review</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
McCarthy, M. and Wilkinson, M. L. (1999) Treatment of Barrett’s esophagus by endoscopic laser ablation and antireflux surgery. Gastrointestinal Endoscopy
|
||
49(1): 129–30 [<a href="https://pubmed.ncbi.nlm.nih.gov/10048955" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10048955</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Study design not relevant to this review protocol-</p>
|
||
<p>Non-randomized study with no active comparator</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
O’Connell, K. and Velanovich, V. (2011) Effects of Nissen fundoplication on endoscopic endoluminal radiofrequency ablation of Barrett’s esophagus. Surgical Endoscopy
|
||
25(3): 830–4 [<a href="https://pubmed.ncbi.nlm.nih.gov/20676687" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20676687</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Study design not relevant to this review protocol-</p>
|
||
<p>Non-randomized study with no active comparator</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
Roorda, A. K.; Marcus, S. N.; Triadafilopoulos, G. (2007) Early experience with radiofrequency energy ablation therapy for Barrett’s esophagus with and without dysplasia. Diseases of the Esophagus
|
||
20(6): 516–22 [<a href="https://pubmed.ncbi.nlm.nih.gov/17958728" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17958728</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Intervention not relevant to this review protocol</p>
|
||
<p>Assessing safety and effectiveness of radiofrequency ablation combined with PPI therapy</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
Salo, J. A., Salminen, J. T., Kiviluoto, T. A.
|
||
et al. (1998) Treatment of Barrett’s esophagus by endoscopic laser ablation and antireflux surgery. Annals of Surgery
|
||
227(1): 40–4 [<a href="/pmc/articles/PMC1191170/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC1191170</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/9445108" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9445108</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Outcomes not relevant to this review protocol</p>
|
||
<p>Assessing regeneration of intestinal metaplasia by squamous epithelium</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
Tyselskyi, V., Poylin, V., Tkachuk, O.
|
||
et al. (2021) Antireflux surgery is required after endoscopic treatment for Barrett’s esophagus. Polski Przeglad Chirurgiczny
|
||
93(5): 1–5 [<a href="https://pubmed.ncbi.nlm.nih.gov/34552027" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34552027</span></a>]
|
||
</td><td headers="hd_h_niceng231er13.apph.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>- Intervention not relevant to this review protocol</p>
|
||
<p>Comparing argon plasma coagulation with high frequency welding</p>
|
||
</td></tr></tbody></table></div></div></div><div id="niceng231er13.apph.s2"><h4>Health Economic studies</h4><p>Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2006 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.</p><p>None.</p></div></div></div><div class="bk_prnt_sctn"><h2>Tables</h2><div class="whole_rhythm bk_prnt_obj bk_first_prnt_obj"><div id="niceng231er13.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595315/table/niceng231er13.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng231er13.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng231er13.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng231er13.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Adults, 18 years and over, with Barrett’s oesophagus with or without dysplasia (low-grade dysplasia, high-grade dysplasia, or stage 1 oesophageal adenocarcinoma).</td></tr><tr><th id="hd_b_niceng231er13.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng231er13.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Anti-reflux surgery alone or in combination with endoscopic treatment: Any type of fundoplication</td></tr><tr><th id="hd_b_niceng231er13.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_niceng231er13.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No anti-reflux surgery</td></tr><tr><th id="hd_b_niceng231er13.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng231er13.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul><li class="half_rhythm"><div>Mortality (disease-specific mortality, treatment related mortality and all cause)</div></li><li class="half_rhythm"><div>Health related quality of life</div></li><li class="half_rhythm"><div>Progression of grade of dysplasia</div></li><li class="half_rhythm"><div>Progression to cancer</div></li><li class="half_rhythm"><div>Recurrence of Barrett’s oesophagus/ dysplasia/cancer</div></li><li class="half_rhythm"><div>Number of endoscopic treatments to achieve remission of Barrett’s</div></li><li class="half_rhythm"><div>Time duration of the endoscopic treatment</div></li><li class="half_rhythm"><div>Adverse events (such as bleeding, pain)</div></li></ul></td></tr><tr><th id="hd_b_niceng231er13.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng231er13.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<ul><li class="half_rhythm"><div>RCT</div></li><li class="half_rhythm"><div>If no RCT data is available, non-randomised studies will be considered only if there is an active comparator within the study</div></li><li class="half_rhythm"><div>Published NMAs and IPDs will be considered for inclusion.</div></li></ul></td></tr></tbody></table></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="niceng231er13.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595315/table/niceng231er13.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng231er13.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_niceng231er13.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng231er13.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention and comparison</th><th id="hd_h_niceng231er13.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_niceng231er13.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng231er13.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng231er13.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Skrobic 2016<a class="bk_pop" href="#niceng231er13.s1.1.ref2"><sup>2</sup></a></td><td headers="hd_h_niceng231er13.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Patients were treated with daily PPI (esomeprazole 40 mg/day) (N=25)</p>
|
||
<p>Vs</p>
|
||
<p>Laparoscopic Nissen fundoplication (LNF) after or synchronous with RFA procedure (N=22)</p>
|
||
</td><td headers="hd_h_niceng231er13.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Patients who had complete eradication of metaplastic and dysplastic Barrett’s oesophagus after HALO endoscopic radiofrequency ablation (RFA) procedure (N=47)</p>
|
||
<p>Mean age (SD): 47.3 (10.8)</p>
|
||
<p>Serbia</p>
|
||
</td><td headers="hd_h_niceng231er13.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>Recurrence of Barrett’s oesophagus</p>
|
||
<p>2-year follow-up</p>
|
||
</td><td headers="hd_h_niceng231er13.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>The post-RFA treatment modality was based on patients’ preference</p>
|
||
<p>Intestinal metaplasia: N=33 (70.2%)</p>
|
||
<p>Low grade dysplasia: N=14 (29.7%)</p>
|
||
</td></tr></tbody></table></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="niceng231er13.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: Anti reflux surgery with endoscopic treatment vs medical treatment</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595315/table/niceng231er13.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng231er13.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng231er13.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng231er13.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng231er13.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng231er13.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">№ of participants (studies) Follow-up</th><th id="hd_h_niceng231er13.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng231er13.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng231er13.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng231er13.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng231er13.tab3_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng231er13.tab3_1_1_1_5" id="hd_h_niceng231er13.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with No Anti reflux surgery</th><th headers="hd_h_niceng231er13.tab3_1_1_1_5" id="hd_h_niceng231er13.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Anti reflux surgery with or without endoscopic treatment</th></tr></thead><tbody><tr><td headers="hd_h_niceng231er13.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of Barrett’s oesophagus</td><td headers="hd_h_niceng231er13.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>47</p>
|
||
<p>(1 observational study)</p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>⨁◯◯◯</p>
|
||
<p>Very Low<sup><a class="bk_pop" href="#niceng231er13.tab3_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#niceng231er13.tab3_2">b</a></sup></p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>RR 0.45</p>
|
||
<p>(0.10 to 2.11)</p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_5 hd_h_niceng231er13.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">200 per 1,000</td><td headers="hd_h_niceng231er13.tab3_1_1_1_5 hd_h_niceng231er13.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>110 fewer per 1,000</p>
|
||
<p>(180 fewer to 222 more)</p>
|
||
</td></tr><tr><td headers="hd_h_niceng231er13.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recurrence of Barrett’s oesophagus C length > 4cm</td><td headers="hd_h_niceng231er13.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>13</p>
|
||
<p>(1 observational study)</p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>⨁◯◯◯</p>
|
||
<p>Very Low<sup><a class="bk_pop" href="#niceng231er13.tab3_1">a</a></sup><sup>,</sup><sup><a class="bk_pop" href="#niceng231er13.tab3_2">b</a></sup></p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>RR 0.30</p>
|
||
<p>(0.10 to 0.89)</p>
|
||
</td><td headers="hd_h_niceng231er13.tab3_1_1_1_5 hd_h_niceng231er13.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1,000 per 1,000</td><td headers="hd_h_niceng231er13.tab3_1_1_1_5 hd_h_niceng231er13.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<p>700 fewer per 1,000</p>
|
||
<p>(900 fewer to 110 fewer)</p>
|
||
</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>a</dt><dd><div id="niceng231er13.tab3_1"><p class="no_margin">Downgraded by 2 increments due to very serious risk of bias.</p></div></dd><dt>b</dt><dd><div id="niceng231er13.tab3_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs (default MIDs for dichotomous outcomes: 0.8 and 1.25)</p></div></dd></dl></div></div></div></div><div class="whole_rhythm bk_prnt_obj"><div id="niceng231er13.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Unit costs</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595315/table/niceng231er13.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng231er13.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unit costs</th><th id="hd_h_niceng231er13.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Source</th></tr></thead><tbody><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Very complex, mouth or throat procedures, with CC scores 0-5+ (CA80A-C)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£17,822<sup><a class="bk_pop" href="#niceng231er13.tab4_1">*</a></sup></td><td headers="hd_h_niceng231er13.tab4_1_1_1_3" rowspan="7" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference costs 2019-20</td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Complex, mouth or throat procedures, 19 years and over, with CC scores 0-2+ (CA81A-B)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£4,058<sup><a class="bk_pop" href="#niceng231er13.tab4_1">*</a></sup></td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Very major, mouth or throat procedures, 19 years and over, with CC scores 0-2+ (CA82A-B)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3,764<sup><a class="bk_pop" href="#niceng231er13.tab4_1">*</a></sup></td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Major, mouth or throat procedures, 19 years and over, with CC scores 0-2+ (CA83A-B)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3,435<sup><a class="bk_pop" href="#niceng231er13.tab4_1">*</a></sup></td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intermediate, mouth or throat procedures, 19 years and over, with CC scores 0-2+ (CA84A-B)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£2,964<sup><a class="bk_pop" href="#niceng231er13.tab4_1">*</a></sup></td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor, mouth or throat procedures, 19 years and over (CA85A)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£514</td></tr><tr><td headers="hd_h_niceng231er13.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor, mouth or throat procedures, 19 years and over (CA86A)</td><td headers="hd_h_niceng231er13.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£338</td></tr></tbody></table></div><div><div><dl class="temp-labeled-list small"><dt>*</dt><dd><div id="niceng231er13.tab4_1"><p class="no_margin">Weighted average unit cost</p></div></dd></dl></div></div></div></div></div><div><p>Final</p></div><div><p>Evidence review underpinning recommendation 1.8.1 in the NICE guideline</p><p>National Institute for Health and Care Excellence</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div></div></div>
|
||
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