US multicenter outcomes of endoscopic ultrasound-guided gallbladder drainage with lumen-apposing metal stents for acute cholecystitis

Abstract

Background and study aims

EUS-guided gallbladder drainage (EUS-GBD) using lumen apposing metal stents (LAMS) has excellent technical and short-term clinical success for acute cholecystitis (AC). The goals of this study were to determine the long-term clinical outcomes and adverse events (AEs) of EUS-GBD with LAMS.

Patients and methods

A multicenter, retrospective study was conducted at 18 US tertiary care institutions. Inclusion criteria: any AC patient with attempted EUS-GBD with LAMS and minimum 30-day post-procedure follow-up. Long-term clinical success was defined as absence of recurrent acute cholecystitis (RAC) > 30 days and long-term AE was defined as occurring > 30 days from the index procedure.

Results

A total of 109 patients were included. Technical success was achieved in 108 of 109 (99.1%) and initial clinical success in 106 of 109 (97.2%). Long-term clinical success was achieved in 98 of 109 (89.9%) over a median follow-up of 140 days (range 30–1188). On multivariable analysis (MVA), acalculous cholecystitis (odds ratio [OR] 15.93, 95% confidence interval [CI] 1.22–208.52, P = 0.04) and the occurrence of a LAMS-specific AE (OR 63.60, 95% CI 5.08–799.29, P <0.01) were associated with RAC. AEs occurred in 38 of 109 patients (34.9%) at any time, and in 10 of 109 (9.17%) > 30 days from the index procedure. Most long-term AEs (7 of 109; 6.42%) were LAMS-specific. No technical or clinical factors were associated with occurrence of AEs. LAMS were removed in 24 of 109 patients (22%). There was no difference in RAC or AEs whether LAMS was removed or not.

Conclusions

EUS-GBD with LAMS has a high rate of long-term clinical success and modest AE rates in patients with AC and is a reasonable destination therapy for high-risk surgical candidates.

Keywords

Endoscopic ultrasonography - Intervention EUS - Biliary tract - Quality and logistical aspects - Performance and complications

Publication History

Received: 14 July 2024

Accepted after revision: 25 November 2024

Article published online:
13 January 2025

• References

• 1 Ansaloni L, Pisano M, Coccolini F. et al. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg 2016; 11: 25
• 2 Okamoto K, Suzuki K, Takada T. et al. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci 2018; 25: 55-72
• 3 Endo I, Takada T, Hwang TL. et al. Optimal treatment strategy for acute cholecystitis based on predictive factors: Japan-Taiwan multicenter cohort study. J Hepatobiliary Pancreat Sci 2017; 24: 346-361
• 4 Alvino DML, Fong ZV, McCarthy CJ. et al. Long-term outcomes following percutaneous cholecystostomy tube placement for treatment of acute calculous cholecystitis. J Gastrointest Surg 2017; 21: 761-769
• 5 Mori Y, Itoi T, Baron TH. et al. Tokyo Guidelines 2018: management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 87-95
• 6 Yun SS, Hwang DW, Kim SW. et al. Better treatment strategies for patients with acute cholecystitis and American Society of Anesthesiologists classification 3 or greater. Yonsei Med J 2010; 51: 540-545
• 7 Altieri MS, Bevilacqua L, Yang J. et al. Cholecystectomy following percutaneous cholecystostomy tube placement leads to higher rate of CBD injuries. Surg Endosc 2019; 33: 2686-2690
• 8 Anderloni A, Buda A, Vieceli F. et al. Endoscopic ultrasound-guided transmural stenting for gallbladder drainage in high-risk patients with acute cholecystitis: a systematic review and pooled analysis. Surg Endosc 2016; 30: 5200-5208
• 9 Itoi T, Binmoeller KF, Shah J. et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75: 870-876
• 10 Bhatt MN, Ghio M, Sadri L. et al. Percutaneous cholecystostomy in acute cholecystitis-predictors of recurrence and interval cholecystectomy. J Surg Res 2018; 232: 539-546
• 11 Chan SM, Teoh AYB, Chiu PWY. et al. Advanced gallbladder interventions after endoscopic ultrasonography-guided gallbladder drainage. Techniq Innov Gastrointest Endosc 2020; 22: 24-26
• 12 Tan YY, Zhao G, Wang D. et al. A new strategy of minimally invasive surgery for cholecystolithiasis: calculi removal and gallbladder preservation. Dig Surg 2013; 30: 466-471
• 13 Higa JT, Sahar N, Kozarek RA. et al. EUS-guided gallbladder drainage with a lumen-apposing metal stent versus endoscopic transpapillary gallbladder drainage for the treatment of acute cholecystitis (with videos). Gastrointest Endosc 2019; 90: 483-492
• 14 Luk SW, Irani S, Krishnamoorthi R. et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy 2019; 51: 722-732
• 15 Mohan BP, Khan SR, Trakroo S. et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy 2020; 52: 96-106
• 16 Oh D, Song TJ, Cho DH. et al. EUS-guided cholecystostomy versus endoscopic transpapillary cholecystostomy for acute cholecystitis in high-risk surgical patients. Gastrointest Endosc 2019; 89: 289-298
• 17 Siddiqui A, Kunda R, Tyberg A. et al. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study. Surg Endosc 2019; 33: 1260-1270
• 18 Teoh AYB, Kitano M, Itoi T. et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut 2020; 69: 1085-1091
• 19 Dollhopf M, Larghi A, Will U. et al. EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device. Gastrointest Endosc 2017; 86: 636-643
• 20 Walter D, Teoh AY, Itoi T. et al. EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut 2016; 65: 6-8
• 21 Yokoe M, Hata J, Takada T. et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 41-54
• 22 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
• 23 James TW, Krafft M, Croglio M. et al. EUS-guided gallbladder drainage in patients with cirrhosis: results of a multicenter retrospective study. Endosc Int Open 2019; 7: E1099-E1104
• 24 Cho DH, Jo SJ, Lee JH. et al. Feasibility and safety of endoscopic ultrasound-guided gallbladder drainage using a newly designed lumen-apposing metal stent. Surg Endosc 2019; 33: 2135-2141
• 25 James TW, Baron TH. EUS-guided gallbladder drainage: A review of current practices and procedures. Endosc Ultrasound 2019; 8: S28-S34
• 26 Ogura T, Higuchi K. Endoscopic ultrasound-guided gallbladder drainage: Current status and future prospects. Dig Endosc 2019; 31: 55-64
• 27 Boregowda U, Umapathy C, Nanjappa A. et al. Endoscopic ultrasound guided gallbladder drainage - is it ready for prime time?. World J Gastrointest Pharmacol Ther 2018; 9: 47-54
• 28 Chan SM, Teoh AYB, Yip HC. et al. Feasibility of per-oral cholecystoscopy and advanced gallbladder interventions after EUS-guided gallbladder stenting (with video). Gastrointest Endosc 2017; 85: 1225-1232
• 29 Teoh AYB, Serna C, Penas I. et al. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy 2017; 49: 130-138
• 30 Tyberg A, Saumoy M, Sequeiros EV. et al. EUS-guided versus percutaneous gallbladder drainage: isn't it time to convert?. J Clin Gastroenterol 2018; 52: 79-84
• 31 Kim SB, Gu MG, Kim KH. et al. Long-term outcomes of acute acalculous cholecystitis treated by non-surgical management. Medicine (Baltimore) 2020; 99: e19057
• 32 Noh SY, Gwon DI, Ko GY. et al. Role of percutaneous cholecystostomy for acute acalculous cholecystitis: clinical outcomes of 271 patients. Eur Radiol 2018; 28: 1449-1455
• 33 Abbas SH, Ghazanfar MA, Gordon-Weeks AN. et al. Acalculous Cholecystitis: Is an elective interval cholecystectomy necessary. Dig Surg 2018; 35: 171-176
• 34 Barie PS, Eachempati SR. Acute acalculous cholecystitis. Gastroenterol Clin North Am 2010; 39: 343-357
• 35 Huffman JL, Schenker S. Acute acalculous cholecystitis: a review. Clin Gastroenterol Hepatol 2010; 8: 15-22
• 36 Cho SH, Oh D, Song TJ. et al. Comparison of the effectiveness and safety of lumen-apposing metal stents and anti-migrating tubular self-expandable metal stents for EUS-guided gallbladder drainage in high surgical risk patients with acute cholecystitis. Gastrointest Endosc 2020; 91: 543-550