TOKYO criteria 2024 for the assessment of clinical outcomes of endoscopic biliary drainage.

endoscopic retrograde cholangiopancreatography endosonography obstructive jaundice stent treatment outcome

Journal

Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society

ISSN: 1443-1661

Titre abrégé: Dig Endosc

Pays: Australia

ID NLM: 9101419

Informations de publication

Date de publication:
06 Jun 2024

Historique:

received: 15 03 2024

accepted: 01 05 2024

medline: 7 6 2024

pubmed: 7 6 2024

entrez: 6 6 2024

Statut: aheadofprint

Résumé

The consensus-based TOKYO criteria were proposed as a standardized reporting system for endoscopic transpapillary biliary drainage. The primary objective was to address issues arising from the inconsistent reporting of stent outcomes across studies, which has complicated the comparability and interpretation of study results. However, the original TOKYO criteria were not readily applicable to recent modalities of endoscopic biliary drainage such as biliary drainage based on endoscopic ultrasound or device-assisted endoscopy. There are increasing opportunities for managing hilar biliary obstruction and benign biliary strictures through endoscopic drainage. Biliary ablation has been introduced to manage benign and malignant biliary strictures. In addition, the prolonged survival times of cancer patients have increased the importance of evaluating overall outcomes during the period requiring endoscopic biliary drainage rather than solely focusing on the patency of the initial stent. Recognizing these unmet needs, a committee has been established within the Japan Gastroenterological Endoscopy Society to revise the TOKYO criteria for current clinical practice. The revised criteria propose not only common reporting items for endoscopic biliary drainage overall, but also items specific to various conditions and interventions. The term "stent-demanding time" has been defined to encompass the entire duration of endoscopic biliary drainage, during which the overall stent-related outcomes are evaluated. The revised TOKYO criteria 2024 are expected to facilitate the design and reporting of clinical studies, providing a goal-oriented approach to the evaluation of endoscopic biliary drainage.

Identifiants

DOI: 10.1111/den.14825 PMID: 38845085

pubmed: 38845085

doi: 10.1111/den.14825

doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

Subventions

Organisme : Daiichi Sankyo Company

Organisme : Takeda Science Foundation

Organisme : Japan Society for the Promotion of Science

ID : JP19K08362

Organisme : Japan Society for the Promotion of Science

ID : JP22H02841

Informations de copyright

Références

Isayama H, Hamada T, Yasuda I et al. Tokyo criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259–264.

Hamada T, Nakai Y, Isayama H. Two meta‐analyses with different conclusions: Stent outcomes should be standardized before their integration. Clin Gastroenterol Hepatol 2013; 11: 748–749.

Hamada T, Hakuta R, Nakai Y, Isayama H, Koike K. Lack in standardized reporting of biliary stents: A meta‐analysis complicated by the inconsistency. Am J Gastroenterol 2017; 112: 809–810.

Jang SI, Lee SJ, Jeong S et al. Efficacy of a multiplex paclitaxel emission stent using a pluronic® mixture membrane versus a covered metal stent in malignant biliary obstruction: A prospective randomized comparative study. Gut Liver 2017; 11: 567–573.

Hamada T, Isayama H, Nakai Y et al. Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial. Dig Endosc 2019; 31: 566–574.

Jang SI, Lee KT, Choi JS et al. Efficacy of a paclitaxel‐eluting biliary metal stent with sodium caprate in malignant biliary obstruction: A prospective randomized comparative study. Endoscopy 2019; 51: 843–851.

Elkilany A, Alwarraky M, Geisel D, Maaly MA, Denecke T. Stent performance in palliative transhepatic treatment of malignant biliary obstruction: A randomized study comparing covered versus uncovered stents. Acta Radiol 2020; 61: 1591–1599.

Hakuta R, Kogure H, Nakai Y et al. Unilateral versus bilateral endoscopic nasobiliary drainage and subsequent metal stent placement for unresectable malignant hilar obstruction: A multicenter randomized controlled trial. J Clin Med 2021; 10: 206.

Kuwatani M, Kawakubo K, Sugimori K et al. Trial protocol: A randomised controlled trial to verify the non‐inferiority of a partially covered self‐expandable metal stent to an uncovered self‐expandable metal stent for biliary drainage during neoadjuvant therapy in patients with pancreatic cancer with obstructive jaundice (PUN‐NAC trial). BMJ Open 2021; 11: e045698.

Shimizu S, Naitoh I, Okumura F et al. One‐step versus two‐step distal self‐expandable metal stent placement: A multicenter prospective randomized trial. J Gastroenterol Hepatol 2021; 36: 2015–2021.

Kato S, Kuwatani M, Onodera M et al. Risk of pancreatitis following biliary stenting with/without endoscopic sphincterotomy: A randomized controlled trial. Clin Gastroenterol Hepatol 2022; 20: 1394–1403.e1.

Matsumoto K, Mitsuhashi T, Kawamoto H et al. Bilateral verses bilateral with tri‐segmental endoscopic drainage using metal stents for high‐grade malignant hilar biliary obstructions: A multicenter, randomized controlled trial: BRAVE study (BRAVE study). Medicine (Baltimore) 2022; 101: e30857.

Paik WH, Jung MK, Kim DU et al. Side‐by‐side placement of fully covered metal stents versus conventional 7F plastic stents in malignant hilar biliary obstruction: Prospective randomized controlled trial. Dig Endosc Published online: 23 Aug 2023; DOI: 10.1111/den.14669

Hasegawa S, Sato T, Shinoda S et al. Braided‐type stent versus laser‐cuttype stent for patients with unresectable distal malignant biliary obstruction: A randomized controlled trial. Gastrointest Endosc Published online: 6 Dec 2023; DOI: 10.1016/j.gie.2023.11.057

Mukai T, Iwata K, Iwashita T et al. Comparison of covered self‐expandable metallic stents with 12‐mm and 10‐mm diameters for unresectable malignant distal biliary obstructions: A prospective randomized trial. Gastrointest Endosc Published online: 22 Nov 2023; DOI: 10.1016/j.gie.2023.11.033

Tsuchiya T, Teoh AYB, Itoi T et al. Long‐term outcomes of EUS‐guided choledochoduodenostomy using a lumen‐apposing metal stent for malignant distal biliary obstruction: A prospective multicenter study. Gastrointest Endosc 2018; 87: 1138–1146.

Ogura T, Higuchi K. Technical review of developments in endoscopic ultrasound‐guided hepaticogastrostomy. Clin Endosc 2021; 54: 651–659.

Ogura T, Itoi T. Technical tips and recent development of endoscopic ultrasound‐guided choledochoduodenostomy. DEN Open 2021; 1: e8.

Chen YI, Sahai A, Donatelli G et al. Endoscopic ultrasound‐guided biliary drainage of first intent with a lumen‐apposing metal stent vs endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction: A multicenter randomized controlled study (ELEMENT trial). Gastroenterology 2023; 165: 1249–1261.e5.

Teoh AYB, Napoleon B, Kunda R et al. EUS‐guided choledocho‐duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction: A multicenter randomized controlled trial (DRA‐MBO trial). Gastroenterology 2023; 165: 473–482.e2.

Okuno N, Hara K, Haba S et al. Novel drill dilator facilitates endoscopic ultrasound‐guided hepaticogastrostomy. Dig Endosc 2023; 35: 389–393.

Mukai S, Itoi T, Sofuni A et al. EUS‐guided antegrade intervention for benign biliary diseases in patients with surgically altered anatomy (with videos). Gastrointest Endosc 2019; 89: 399–407.

Iwashita T, Uemura S, Tezuka R, Senju A, Yasuda I, Shimizu M. Current status of endoscopic ultrasound‐guided antegrade intervention for biliary diseases in patients with surgically altered anatomy. Dig Endosc 2023; 35: 264–274.

Shimatani M, Hatanaka H, Kogure H et al. Diagnostic and therapeutic endoscopic retrograde cholangiography using a short‐type double‐balloon endoscope in patients with altered gastrointestinal anatomy: A multicenter prospective study in Japan. Am J Gastroenterol 2016; 111: 1750–1758.

Sato T, Kogure H, Nakai Y et al. A prospective study of fully covered metal stents for different types of refractory benign biliary strictures. Endoscopy 2020; 52: 368–376.

Sato T, Kogure H, Nakai Y et al. Endoscopic treatment of hepaticojejunostomy anastomotic strictures using fully‐covered metal stents. Dig Endosc 2021; 33: 451–457.

Takeda T, Sasaki T, Mie T et al. The safety and efficacy of self‐expandable metallic stent placement for malignant biliary obstruction with surgically altered anatomy. Scand J Gastroenterol 2021; 56: 94–102.

Tanisaka Y, Ryozawa S, Mizuide M et al. Usefulness of self‐expandable metal stents for malignant biliary obstruction using a short‐type single‐balloon enteroscope in patients with surgically altered anatomy. J Hepatobiliary Pancreat Sci 2021; 28: 272–279.

Tanisaka Y, Ryozawa S, Itoi T et al. Efficacy and factors affecting procedure results of short‐type single‐balloon enteroscopy‐assisted ERCP for altered anatomy: A multicenter cohort in Japan. Gastrointest Endosc 2022; 95: 310–318.e1.

Hamada T, Nakai Y, Isayama H. Tokyo criteria: Standardized reporting system for endoscopic biliary stent placement. Gastrointest Interv 2018; 7: 46–51.

Andrasina T, Rohan T, Panek J et al. The combination of endoluminal radiofrequency ablation and metal stent implantation for the treatment of malignant biliary stenosis – Randomized study. Eur J Radiol 2021; 142: 109830.

Albers D, Schmidt A, Schiemer M et al. Impact of endobiliary radiofrequency ablation on biliary drainage in patients with malignant biliary strictures treated with uncovered self‐expandable metal stents: A randomized controlled multicenter trial. Gastrointest Endosc 2022; 96: 970–979.

Jarosova J, Zarivnijova L, Cibulkova I et al. Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: A randomised trial. Gut 2023; 72: 2286–2293.

Seo DW, Sherman S, Dua KS et al. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: A randomized trial. Gastrointest Endosc 2019; 90: 602–612.e4.

Tamura T, Itonaga M, Ashida R et al. Covered self‐expandable metal stents versus plastic stents for preoperative biliary drainage in patient receiving neo‐adjuvant chemotherapy for borderline resectable pancreatic cancer: Prospective randomized study. Dig Endosc 2021; 33: 1170–1178.

Mukai S, Itoi T, Tsuchiya T et al. Clinical feasibility of endoscopic ultrasound‐guided biliary drainage for preoperative management of malignant biliary obstruction (with videos). J Hepatobiliary Pancreat Sci 2023; 30: 983–992.

Coté GA, Slivka A, Tarnasky P et al. Effect of covered metallic stents compared with plastic stents on benign biliary stricture resolution: A randomized clinical trial. JAMA 2016; 315: 1250–1257.

Ramchandani M, Lakhtakia S, Costamagna G et al. Fully covered self‐expanding metal stent vs multiple plastic stents to treat benign biliary strictures secondary to chronic pancreatitis: A multicenter randomized trial. Gastroenterology 2021; 161: 185–195.

Telford JJ, Carr‐Locke DL, Baron TH et al. A randomized trial comparing uncovered and partially covered self‐expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 2010; 72: 907–914.

Kullman E, Frozanpor F, Soderlund C et al. Covered versus uncovered self‐expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: Results from a randomized, multicenter study. Gastrointest Endosc 2010; 72: 915–923.

Ung KA, Stotzer PO, Nilsson A, Gustavsson ML, Johnsson E. Covered and uncovered self‐expandable metallic hanarostents are equally efficacious in the drainage of extrahepatic malignant strictures. Results of a double‐blind randomized study. Scand J Gastroenterol 2013; 48: 459–465.

Kitano M, Yamashita Y, Tanaka K et al. Covered self‐expandable metal stents with an antimigration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: A randomized multicenter trial. Am J Gastroenterol 2013; 108: 1713–1722.

Yang MJ, Kim JH, Yoo BM et al. Partially covered versus uncovered self‐expandable nitinol stents with antimigration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol 2015; 50: 1490–1499.

Conio M, Mangiavillano B, Caruso A et al. Covered versus uncovered self‐expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: A randomized multicenter study. Gastrointest Endosc 2018; 88: 283–291.e3.

Sakai Y, Sugiyama H, Kawaguchi Y et al. Uncovered versus covered metallic stents for the management of unresectable malignant distal biliary obstruction: A randomized multicenter trial. Scand J Gastroenterol 2021; 56: 1229–1235.

Park SW, Lee KJ, Chung MJ et al. Covered versus uncovered double bare self‐expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: A randomized controlled multicenter trial. Gastrointest Endosc 2023; 97: 132–142.e2.

Okuno M, Mukai T, Iwashita T et al. Evaluation of endoscopic reintervention for self‐expandable metallic stent obstruction after stent‐in‐stent placement for malignant hilar biliary obstruction. J Hepatobiliary Pancreat Sci 2019; 26: 211–218.

Takenaka M, Kudo M. Endoscopic reintervention for recurrence of malignant biliary obstruction: Developing the best strategy. Gut Liver 2022; 16: 525–534.

Kanno Y, Ito K, Nakahara K et al. Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: A multicenter, randomized trial. Gastrointest Endosc 2023; 98: 211–221.e3.

Al Nakshabandi A, Ali FS, Albustami I et al. Biliary drainage in hilar and perihilar cholangiocarcinoma; 25‐year experience at a tertiary cancer center. Gastrointest Endosc Published online: 11 Dec 2023; DOI: 10.1016/j.gie.2023.12.006

van der Gaag NA, Rauws EA, van Eijck CH et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010; 362: 129–137.

Inoue T, Yoshida M, Suzuki Y et al. Comparison of the long‐term outcomes of EUS‐guided gallbladder drainage and endoscopic transpapillary gallbladder drainage for calculous cholecystitis in poor surgical candidates: A multicenter propensity score‐matched analysis. Gastrointest Endosc 2023; 98: 362–370.

Kiriyama S, Kozaka K, Takada T et al. Tokyo guidelines 2018: Diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 17–30.

Almadi MA, Barkun A, Martel M. Plastic vs. self‐expandable metal stents for palliation in malignant biliary obstruction: A series of meta‐analyses. Am J Gastroenterol 2017; 112: 260–273.

Isayama H, Komatsu Y, Tsujino T et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729–734.

Tamura T, Yamai T, Uza N et al. Adverse events of self‐expandable metal stent placement for malignant distal biliary obstruction: A large multicenter study. Gastrointest Endosc 2024; 99: 61–72.e8.

Yamashita Y, Tachikawa A, Shimokawa T et al. Covered versus uncovered metal stent for endoscopic drainage of a malignant distal biliary obstruction: Meta‐analysis. Dig Endosc 2022; 34: 938–951.

Vanella G, Coluccio C, Cucchetti A et al. Fully covered versus partially covered self‐expandable metal stents for palliation of distal malignant biliary obstruction: A systematic review and meta‐analysis. Gastrointest Endosc 2024; 99: 314–322.e19.

Vanella G, Bronswijk M, Dell'Anna G et al. Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow‐up of endoscopic ultrasound‐guided choledochoduodenostomy: Multicenter evaluation from the Leuven‐Amsterdam‐Milan Study Group. Dig Endosc 2023; 35: 377–388.

Hamada T, Nakai Y, Isayama H et al. Estimation and comparison of cumulative incidences of biliary self‐expandable metallic stent dysfunction accounting for competing risks. Dig Endosc 2014; 26: 270–275.

Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: An attempt at consensus. Gastrointest Endosc 1991; 37: 383–393.

Cotton PB, Eisen GM, Aabakken L et al. A lexicon for endoscopic adverse events: Report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446–454.

Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649–655.

Ishii T, Hayashi T, Yamazaki H et al. Risk factors for early and late cholecystitis after covered metal stent placement for distal biliary obstruction. J Hepatobiliary Pancreat Sci 2023; 30: 1180–1187.

Toyonaga H, Hayashi T, Yamazaki H et al. Efficacy of pancreatic duct stenting to prevent postendoscopic retrograde cholangiopancreatography pancreatitis after covered self‐expandable metal stent deployment. Dig Endosc 2023; 35: 369–376.

Dumonceau JM, Kapral C, Aabakken L et al. ERCP‐related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2020; 52: 127–149.

Buxbaum JL, Freeman M, Amateau SK et al. American Society for Gastrointestinal Endoscopy guideline on post‐ERCP pancreatitis prevention strategies: Summary and recommendations. Gastrointest Endosc 2023; 97: 153–162.

Clavien PA, Barkun J, de Oliveira ML et al. The Clavien‐Dindo classification of surgical complications: Five‐year experience. Ann Surg 2009; 250: 187–196.

Nebiki H, Fujita K, Yazumi S et al. Does endoscopic sphincterotomy contribute to the prevention of post‐endoscopic retrograde cholangiopancreatography pancreatitis after endoscopic biliary stenting for malignant biliary obstruction? A multicenter prospective cohort study. Surg Endosc 2023; 37: 3463–3470.

Bismuth H, Majno PE. Biliary strictures: Classification based on the principles of surgical treatment. World J Surg 2001; 25: 1241–1244.

Fukasawa M, Takano S, Shindo H, Takahashi E, Sato T, Enomoto N. Endoscopic biliary stenting for unresectable malignant hilar obstruction. Clin J Gastroenterol 2017; 10: 485–490.

Naitoh I, Inoue T. Optimal endoscopic drainage strategy for unresectable malignant hilar biliary obstruction. Clin Endosc 2023; 56: 135–142.