ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction

This clinical guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach management of patients with malignant hilar obstruction (MHO). document was developed using Grading Recommendations Assessment, Development and Evaluation framework addresses primary drainage modality (percutaneous transhepatic biliary [PTBD] vs endoscopic [EBD]), strategy (unilateral bilateral), stent selection (plastic [PS] self-expandable metal [SEMS]). Regarding modality, in MHO undergoing before potential resection or transplantation, panel suggests against routine use PTBD as first-line therapy compared EBD. In unresectable palliative drainage, The final decision should be based on patient preferences, disease characteristics, local expertise. strategy, placement, placement bilateral stents a unilateral absence liver atrophy. Finally, regarding type stent, placing SEMSs PSs. However, who have short life expectancy place high value avoiding repeated interventions, If optimal has not been established, clearly outlines process, analyses, processes used to reach recommendations represents official ASGE above topics. Patients (MHO) frequently present signs symptoms obstruction. can occur because several types malignancies including tumors tract involving hilum (Klatskin tumors), extension adjacent cancers (gallbladder cancer), metastatic involvement lymph nodes extrinsic compression.1Van Dyke A.L. Shiels M.S. Jones G.S. et al.Biliary cancer incidence trends United States by demographic group, 1999-2013.Cancer. 2019; 125: 1489-1498Crossref PubMed Scopus (46) Google Scholar is devastating disease, 5-year survival rate less than 10%.2Jarnagin W.R. Fong Y. DeMatteo R.P. al.Staging, resectability, outcome 225 cholangiocarcinoma.Ann Surg. 2001; 234 (discussion 517-9): 507-517Crossref (1032) Approximately 73% lesions causing are either after preoperative staging R0 (resection cure) achievable at time surgery. Surgery typically involves partial hepatectomy, which performed select centers States.3Siegel R. Ma J. Zou Z. al.Cancer statistics, 2014.CA Cancer J Clin. 2014; 64: 9-29Crossref (10668) Thus, most require some form symptomatic relief (eg, pain, jaundice, etc) prevent adverse events (AEs) cholestasis (pruritus, cholangitis, part assessment preserve function. Accomplishing goals challenging. For instance, self-expanding metallic [SEMS]) defined MHO. Similarly, among potentially resectable MHO, often required. There limited guidance whether percutaneous (PTBD) (EBD) appropriate route this population. document, we body evidence provide addressing these important questions. We aim evidence-based, clinically relevant guidelines conceptualized conducted according (GRADE) framework, previously described.4Wani S. Qumseya B. al.Standards Practice CommitteeEndoscopic eradication Barrett's esophagus-associated dysplasia intramucosal cancer.Gastrointest Endosc. 2018; 87: 907-931Abstract Full Text PDF (61) Scholar,5Qumseya Sultan al.ASGE Standards CommitteeASGE screening surveillance esophagus.Gastrointest 90: 335-359Abstract (82) Governing Board approved publication. invited stakeholders involved discussion formulation recommendations. included content expert (B.J.E.), interventional radiologist (A.R.), pancreaticobiliary surgeon (E.P.C.), advocate (P.M.), GRADE methodologist (B.J.Q.), members Pratice committee. representative Cholangiocarcinoma Foundation (https://cholangiocarcinoma.org). meeting held Chicago, Illinois, USA March 7, 2020. All were asked disclose conflicts interests policy (https://www.asge.org/forms/conflict-of-interest-disclosure https://www.asge.org/docs/default-source/about-asge/mission-and-governance/asge-conflict-of-interest-and-disclosure-policy.pdf). Clinical questions formulated population, intervention, comparison, outcome, PICO, format. Critical outcomes survival, postprocedure mortality, success rates (functional technical), outcomes. aimed address 3 outlined Table 3.Table 1Summary considerationCategoryPopulationConsiderationsRecommendationStent typeUnresectable MHOShort prefers interventionsSuggest (SEMSs)Optimal establishedSuggest PSsOtherwiseSuggest PSsDrainage strategyUnresectable MHO—Suggest stentsDrainage modalityMHOPotentially operativeSuggest treatmentUnresectable palliativeSuggest EBD PTBDMHO, Malignant obstruction; SEMS, stent; PS, plastic PTBD, drainage; EBD, drainage. Open table new tab Our literature search done help librarian. started searching existing systematic reviews. such reviews identified, citations studies reviewed inclusion. updated, any also considered predefined inclusion exclusion criteria. Inclusion criteria all randomized controlled trials, cohort, case-control, retrospective studies, abstracts 2018-2019. Included malignancy assessed duration, latency, technical success, therapeutic outcomes, re-intervention rate, events. A total 25 See Appendix (available online www.giejournal.org) full strategies database details. imported into covidence.org 2 independent reviewers (B.J.Q. L.H.J.), resolved consensus. extracted data time, mortality rates, patency, reintervention AEs. Data Excel spreadsheet (Microsoft Corporation, Redmond, Wash, USA). heterogeneity I2 test, funnel plots assess publication bias. Forest constructed magnitude direction effect estimate. Based format,6Guyatt G.H. Oxman A.D. Vist G.E. al.GRADE: emerging consensus rating quality strength recommendations.BMJ. 2008; 336: 924-926Crossref each risk bias, inconsistency, indirectness, imprecision, bias GRADEpro-GDT website (http://gdt.guidelinedevelopment.org/app). rated very low high. certainty discussed detail during meeting, forest presented. addition evidence, other factors making recommendations: balance desirable undesirable effects, costs, cost-effectiveness, values preference, equity, acceptability, feasibility interventions comparisons. Final terms “recommend” denote strong “suggest” conditional categories their interpretation clinicians detailed Tables 4 5.Table 2General concepts obstruction1.Review cross-section imaging, emphasis volumetric assessment2.Discuss case multidisciplinary fashion, especially disease3.Limit injection contrast4.Avoid attempted dilated bile ducts within atrophic segments5.Attempt injected segments6.Aim drain >50% viable (nonatrophic) volume, includes future remnant patients7.Consider periprocedure antibiotics, if contrast believed incomplete8.May stent-in-stent stent-by-stent approach9.Radiofrequency ablation photodynamic ablate through tertiary research settings 3List format ratingsPopulationInterventionComparatorOutcomesRatingPatients obstructionSelf-expandable stentsPlastic stents•SurvivalCritical•Stent patencyCritical•ReinterventionCritical•Success rateCritical•Adverse eventsCriticalPatients obstructionBilateral placementUnilateral placement•SurvivalCritical•Stent patencyCritical•Success obstructionEndoscopic drainagePercutaneous drainage•Postprocedure mortalityCritical•SurvivalCritical•Success conversion rateCritical•Peritoneal metastasis tube seedingCritical•Adverse eventsCritical Details summarized 1 graphical abstract. General 2.Table 4Grading evidenceQuality evidenceMeaningInterpretationHighWe confident that true lies close estimate effect.Further unlikely change our confidence effect.ModerateWe moderately effect; likely effect, but there possibility it substantially different.Further impact may estimate.LowOur limited; different estimate.Very lowWe little effect.Any uncertain. 5Interpretation definitions recommendation frameworkImplications forStrong recommendationConditional recommendationPatientsMost individuals situation would want recommended course action, only small proportion not.Most suggested many not.CliniciansMost receive intervention. Formal aids needed individual make decisions consistent preferences.Recognize choices will you must arrive his her preferences. Decision useful helping preferences.PolicymakersThe adopted situations. Compliance could criterion performance indicator.Policymaking substantial debate various stakeholders. Recommendation 1: following:•SEMSs PSs (<3 months) those interventions.•PSs established.•Otherwise, expertise physician preference.(Conditional recommendations, Low evidence) identified review Sawas al,7Sawas T. Al Halabi Parsi M.A. al.Self-expandable versus obstruction: meta-analysis.Gastrointest 2015; 82 (256-6)Abstract (124) 5 comparative studies,2Jarnagin Scholar,8Sangchan A. Kongkasame W. Pugkhem al.Efficacy complex cholangiocarcinoma: trial.Gastrointest 2012; 76: 93-99Abstract (138) Scholar, 9Wagner H.J. Knyrim K. Vakil N. al.Plastic endoprostheses treatment prospective trial.Endoscopy. 1993; 25: 213-218Crossref (322) 10Liberato M.J. Canena J.M. Endoscopic stenting efficacy 480 patients.BMC Gastroenterol. 12: 103Crossref (107) 11Raju Jaganmohan S.R. Ross W.A. al.Optimum palliation inoperable stents.Dig Dis Sci. 2011; 56: 1557-1564Crossref (68) trials (RCTs). additional abstract,12Choi J.H. Lee S.H. You al.Step-wise advanced obstruction.Sci Rep. 9: 13207Crossref (3) 13Gao D.J. Hu Ye X. al.Metal gallbladder duct obstruction.Dig 2017; 29: 97-103Crossref (8) 14Iwasaki Sato Hosono stents, rather contribute Klatskin tumor [abstract].Gastrointest AB228Abstract update (from 2016 2019). advantages higher patency lower success. Improved noted RCT.8Sangchan no difference insertion 30-day pancreatitis between expressed concern about factors. First, RCTs PS group did undergo scheduled exchanges current practices. Second, reintervention, procedure exchanging much easier restenting occluded SEMS. months), possibly improved data. cases, endoscopists know best side drained cannot confirm resectable. panels while made, placed needed. (defined decrease serum bilirubin <75% month, studies), (overall AEs, pancreatitis). profile summarizing methodology Supplementary www.giejournal.org). Figures RCTs. Sangchan al8Sangchan showed significant benefit underwent SEMS placement. Mukai al2Jarnagin trend toward better SEMSs, statistically significant. On meta-analysis, improvement (difference means, 56 days [confidence interval {CI}, 12-101]; = 33%, P .01) (Supplementary Fig. 1A). Evidence down imprecision assumption normality (analysis medians means). moderate. Adding cohort still increased statistical significance 33 [CI, –3 69]; 55%, .07). RCTs2Jarnagin median standardized mean (SMD) large (SMD, .86 .55-1.18]; 0%, < .001). assuming normality. RCTs, .64 .46-.82]; 52%, .001) 1B). found odds Scholar,9Wagner (odds ratio [OR], .34; [CI], .16-.70; number events, results (OR, .33; 95% CI, .21-.53; 38%, 1C). Insertion informed 6.38; .86-47.45; .07) 1D). wide thus ending moderate evidence. RCT studies. Drainage 2.82; 1.19-6.69; 42%, .019) 1E). low. As 1, cholangitis groups Figs. 1F,G). 8 cases arm, whereas study Gao al13Gao group. recognized cost greater savings requiring fewer interventions. Two looked concluded more efficient. One costly. cost-effectiveness analyses States. Walter al15Walter D. van Boeckel P.G. Groenen al.Cost extrahepatic trial.Gastroenterology. 149: 130-138Abstract studied year differ. Yeoh al16Yeoh K.G. Zimmerman Cunningham J.T. al.Comparative costs obstructive jaundice analysis.Gastrointest 1999; 49: 466-471Abstract (171) jaundice. Their analysis initial followed economical option. above, decided overall judgment probably favors SEMSs. reporting values. advocate, assumed reintervention. observational Choi al12Choi reported PTBD-free importance permanent technically challenging next ERCP. deliberated recommending disadvantageous resource-poor where too expensive available. issue equity available settings. both feasible acceptable. Despite presented data, Some issues follows:•Patients waited until occlusion occurred. prolonged (>3 caused occlusion, resulted worse survival. Scheduled replacement real-life practice. Therefore, translate daily practice.•If requires when placed. notion supported Iwasaki al,14Iwasaki T