Skip to main content
SpringerLink
Log in

A novel gallbladder umbrella stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model

  • New Technology
  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Background and aims

Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder stent for blockage of gallstone migration, the Shai™ Stent. The Shai stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks.

Methods

The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal stent delivery system. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the stent into the gallbladder of pigs. In addition, the short-term safety of the stent was evaluated.

Results

Fifteen stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15–37). The maximum follow-up before sacrifice was 42 days. The stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement.

Conclusions

Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this stent as an innovative biotechnology to block gallstones from migration and impaction.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8

Similar content being viewed by others

References

  1. Stinton LM, Shaffer EA (2012) Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver 6:172–187

    Article  PubMed  PubMed Central  Google Scholar 

  2. Williams E, Beckingham I, El SG, Gurusamy K, Sturgess R, Webster G, Young T (2017) Updated guideline on the management of common bile duct stones (CBDS). Gut 66:765–782

    Article  PubMed  Google Scholar 

  3. Livingston EH, Rege RV (2004) A nationwide study of conversion from laparoscopic to open cholecystectomy. Am J Surg 188:205–211

    Article  PubMed  Google Scholar 

  4. Kama NA, Kologlu M, Doganay M, Reis E, Atli M, Dolapci M (2001) A risk score for conversion from laparoscopic to open cholecystectomy. Am J Surg 181:520–525

    Article  CAS  PubMed  Google Scholar 

  5. Rosen M, Brody F, Ponsky J (2002) Predictive factors for conversion of laparoscopic cholecystectomy. Am J Surg 184:254–258

    Article  PubMed  Google Scholar 

  6. Lee TH, Park DH, Lee SS, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ (2011) Outcomes of endoscopic transpapillary gallbladder stenting for symptomatic gallbladder diseases: a multicenter prospective follow-up study. Endoscopy 43:702–708

    Article  CAS  PubMed  Google Scholar 

  7. Itoi T, Coelho-Prabhu N, Baron TH (2010) Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc 71:1038–1045

    Article  PubMed  Google Scholar 

  8. Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, Tsuji S, Ikeuchi N, Tsukamoto S, Takeuchi M, Kawai T, Moriyasu F (2008) Endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis in whom percutaneous transhepatic approach is contraindicated or anatomically impossible (with video). Gastrointest Endosc 68:455–460

    Article  PubMed  Google Scholar 

  9. Naitoh I, Nakazawa T, Miyabe K, Mizoguchi K, Kimura M, Takeyama H, Joh T (2015) A cholecystocolonic fistula caused by penetration of a double-pigtail plastic stent after endoscopic transpapillary gallbladder stenting. Endoscopy 47:E399–E400

    Article  PubMed  Google Scholar 

  10. Sarwar A, Zhou L, Chakrala N, Brook OR, Weinstein JL, Rosen MP, Ahmed M (2017) The relevance of readmissions after common IR procedures: readmission rates and association with early mortality. J Vasc Interv Radiol 28:629

    Article  PubMed  Google Scholar 

  11. Ryozawa S, Fujita N, Irisawa A, Hirooka Y, Mine T (2017) Current status of interventional endoscopic ultrasound. Dig Endosc 29:559

    Article  PubMed  Google Scholar 

  12. Shaffer EA (2005) Epidemiology and risk factors for gallstone disease: has the paradigm changed in the 21st century? Curr Gastroenterol Rep 7:132–140

    Article  PubMed  Google Scholar 

  13. Kratzer W, Mason RA, Kachele V (1999) Prevalence of gallstones in sonographic surveys worldwide. J Clin Ultrasound 27:1–7

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy

    Ivo Boškoski, Andrea Tringali & Guido Costamagna

  2. Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore, Rome, Italy

    Ivo Boškoski, Andrea Tringali & Guido Costamagna

  3. Department of Gastroenterology and Hepatology, Meir Medical Center, Kfar Saba, Israel

    Fred M. Konikoff

  4. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Fred M. Konikoff

  5. Lithiblock Ltd, Kiryat Gat, Israel

    Shmuel Ben Muvhar

  6. Health Services Ltd, Savyon, Israel

    Jonathan Tsehori

Authors
  1. Ivo Boškoski
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Fred M. Konikoff
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Shmuel Ben Muvhar
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Andrea Tringali
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jonathan Tsehori
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Guido Costamagna
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ivo Boškoski.

Ethics declarations

Disclosures

Mr. Shmuel Ben Muvhar is the CEO of Lithiblock. On the 8th of April Dr. Ivo Boskoski won a research Grant from Apollo endosurgery and also a consultancy agreement was signed. Prof. Guido Costamagna, Dr. Andrea Tringali, Prof. Fred M. Konikoff, and Dr. Jonathan Tsehori have no conflicts of interest or financial ties to disclose.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Boškoski, I., Konikoff, F.M., Ben Muvhar, S. et al. A novel gallbladder umbrella stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model. Surg Endosc 33, 3050–3055 (2019). https://doi.org/10.1007/s00464-019-06993-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-019-06993-7

Keywords

Search

Navigation