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Original research
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)
  1. Anthony Y B Teoh1,
  2. Masayuki Kitano2,
  3. Takao Itoi3,
  4. Manuel Pérez-Miranda4,
  5. Takeshi Ogura5,
  6. Shannon Melissa Chan1,
  7. Carlos Serna-Higuera4,
  8. Shunsuke Omoto6,
  9. Raul Torres-Yuste4,
  10. Takayoshi Tsuichiya3,
  11. Ka Tak Wong7,
  12. Chi-Ho Leung1,
  13. Philip Wai Yan Chiu1,
  14. Enders Kwok Wai Ng1,
  15. James Yun Wong Lau1
  1. 1 Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China
  2. 2 Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Wakayama, Japan
  3. 3 Department of Gastroenterology and Hepatology, Tokyo Medical University Hospital, Tokyo, Japan
  4. 4 Gastroenterology and Hepatology, University Hospital Rio Hortega, Valladolid, Spain
  5. 5 2nd Department of Internal Medicine, Osaka Medical College, Takatuki, Japan
  6. 6 Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan
  7. 7 Department of Diagnostic Radiology and Organ Imaging, The Chinese University of Hong Kong, Hong Kong, China
  1. Correspondence to Professor Anthony Y B Teoh, Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong; anthonyteoh{at}surgery.cuhk.edu.hk

Abstract

Objective The optimal management of acute cholecystitis in patients at very high risk for cholecystectomy is uncertain. The aim of the current study was to compare endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomised controlled trial.

Design Consecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities.

Results Between August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1 year adverse events (10 (25.6%) vs 31 (77.5%), p<0.001), 30-day adverse events (5 (12.8%) vs 19 (47.5%), p=0.010), re-interventions after 30 days (1/39 (2.6%) vs 12/40 (30%), p=0.001), number of unplanned readmissions (6/39 (15.4%) vs 20/40 (50%), p=0.002) and recurrent cholecystitis (1/39 (2.6%) vs 8/40 (20%), p=0.029). Postprocedural pain scores and analgesic requirements were also less (p=0.034). The technical success (97.4% vs 100%, p=0.494), clinical success (92.3% vs 92.5%, p=1) and 30-day mortality (7.7% vs 10%, p=1) were statistically similar. The predictor to recurrent acute cholecystitis was the performance of PT-GBD (OR (95% CI)=5.63 (1.20–53.90), p=0.027).

Conclusion EUS-GBD improved outcomes as compared to PT-GBD in those patients that not candidates for cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available after a multi-disciplinary meeting. Further studies are required to determine the long-term efficacy.

Trial registration number NCT02212717

  • EUS-guided gallbladder drainage
  • percutaneous cholecystostomy
  • acute cholecystitis
  • interventional endoscopic ultrasonography
  • lumen apposing metal stents
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Footnotes

  • Contributors AYBT was responsible for study design, data collection, analysis of data and writing of the manuscript.MK, MP-M, TO, SC, CS-H, SO, RT-Y and TT were responsible for data collection and analysis of data. TI was responsible for study design and data collection analysis of data. KTW was responsible for data collection, analysis of data and writing of the manuscript. C-HL was responsible for analysis of data and writing of the manuscript. PWYC, EKN and JL were responsible for study design, analysis of data and final approval of the manuscript.

  • Funding This study was supported by the American Society of Gastrointestinal Endoscopy research awards.

  • Competing interests AYBT is a consultant for Boston Scientific, Cook, Taewoong and Microtech Medical Corporations.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. Individual data that underlie the results reported in this article after deidentification.

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