Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

The feasibility of delivering a duodenal–jejunal bypass liner (endobarrier) endoscopically with patients under conscious sedation

Abstract

Background

The endoscopically placed duodenal–jejunal bypass liner (DJBL) or EndoBarrier gastrointestinal liner has been designed for the treatment of type 2 diabetes mellitus and simultaneous achievement of weight loss by obese patients. This study was performed to determine the safety, efficacy, and feasibility of delivering the DJBL with the patient under conscious sedation (CS). The primary end points of the study were safety and complications. The secondary end points were delivery time (min), amount of propofol (mg) used, and the total hospital stay (h).

Methods

This prospective study compared placement of the DJBL with the patient under propofol sedation and placement with the patient under general anesthesia (GA). The study included 56 patients, with 28 patients in each group.

Results

Both groups were comparable in terms of age, gender, and body mass index. All the devices were placed successfully, and no complications occurred in either group. Comparison of the CS group with the GA group respectively showed a mean total operation time of 29 versus 56 min, a mean propofol use of 170 versus 258 mg, and a mean hospital stay of 11 versus 22 h.

Conclusion

Delivery of the DJBL to patients under CS is feasible, safe, and efficient in terms of time and cost. Because of possible complications during the procedure, the authors recommend placement of the DJBL with the patient under CS in proximity to the operating room.

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

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

References

  1. 1.

    Flegal KM, Carroll MD, Ogden CL, Curtin LR (2010) Prevalence and trends in obesity among US adults, 1999–2008. JAMA 303:235–241

  2. 2.

    Wild S, Roglic G, Green A, Sicree R, King H (2004) Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 27:1047–1053

  3. 3.

    Kelly T, Yang W, Chen CS, Reynolds K, He J (2008) Global burden of obesity in 2005 and projections to 2030. Int J Obes 32:1431–1437

  4. 4.

    Buchwald H, Avidor Y, Braunwald E, Jansen MD, Pories W, Fahrbach K (2004) Bariatric surgery: a systemic review and meta-analysis. JAMA 292:1724–1737

  5. 5.

    Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ (2009) The clinical effectiveness and cost effectiveness of bariatric (weight loss) surgery for obesity: systematic review and economic evaluation. Health Technol Assess 13(1–190):215–357

  6. 6.

    Heo YS, Park JM, Kim YJ, Kim SM, Park DJ, Lee SK, Han SM, Shim KW, Lee YJ, Lee JY, Kwon JW (2012) Bariatric surgery versus conventional therapy in obese Korea patients: a multicenter retrospective cohort study. J Korean Surg Soc 83:335–342

  7. 7.

    Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Ouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H (2004) Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 351:2683–2693

  8. 8.

    Buchwald H, Oien DM (2009) Metabolic/bariatric surgery worldwide 2008. Obes Surg 19:1605–1611

  9. 9.

    Morino M, Toppino M, Forestieri P, Angrisani L, Allaix ME, Scopinaro N (2007) Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry. Ann Surg 246:1002–1007 (Discussion 1007–1009)

  10. 10.

    Schauer P, Chand B, Brethauer S (2007) New applications for endoscopy: the emerging field of endoluminal and transgastric bariatric surgery. Surg Endosc 21:347–356

  11. 11.

    Hazey JW, Dunkin BJ, Melvin WS (2007) Changing attitudes toward endoluminal therapy. Surg Endosc 21:445–448

  12. 12.

    Malik A, Mellinger JD, Hazey JW, Dunkin BJ, MacFadyen BV Jr (2006) Endoluminal and transluminal surgery: current status and future possibilities. Surg Endosc 20:1179–1192

  13. 13.

    Gostout CJ, Rajan E (2005) Endoscopic treatments for obesity: past, present, and future. Gastroenterol Clin North Am 34:143–150

  14. 14.

    Cote GA, Edmundowicz SA (2009) Emerging technology: endoluminal treatment of obesity. Gastrointest Endosc 70:991–999

  15. 15.

    Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW (2010) A multicenter, randomized efficacy study of the EndoBarrier gastrointestinal liner for presurgical weight loss prior to bariatric surgery. Ann Surg 251:236–243

  16. 16.

    Rodriguez-Grunert L, Galvao Neto MP, Alamo M, Ramos AC, Baez PB, Tarnoff M (2008) First human experience with endoscopically delivered and retrieved duodenal–jejunal bypass sleeve. Surg Obes Relat Dis 4:55–59

  17. 17.

    Rodriguez L, Reyes E, Fagalde P, Oltra MS, Saba J, Aylwin CG, Prieto C, Ramos A, Galvao M, Gersin KS, Sorli C (2009) Pilot clinical study of an endoscopic, removable duodenal–jejunal bypass liner for the treatment of type 2 diabetes. Diabetes Technol Ther 11:725–732

  18. 18.

    Tarnoff M, Rodriguez L, Escalona A, Ramos A, Neto M, Alamo M, Reyes E, Pimentel F, Ibanez L (2009) Open label, prospective, randomized controlled trial of an endoscopic duodenal–jejunal bypass sleeve versus low-calorie diet for preoperative weight loss in bariatric surgery. Surg Endosc 23:650–656

  19. 19.

    Gersin KS, Rothstein RI, Rosenthal RJ, Stefanidis D, Deal SE, Kuwada TS, Laycock W, Adrales G, Vassiliou M, Szomstein S, Heller S, Joyce AM, Heiss F, Nepomnayshy D (2010) Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointest Endosc 71:976–982

  20. 20.

    de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Júnior AB, Mancini MC, Halpern A, Cecconello I (2012) Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal–jejunal bypass liner. Diabetes Technol Ther 14:183–189

  21. 21.

    de Moura EG, Orso IR, Martins Bda C, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P (2011) Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg 21:941–947

  22. 22.

    Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Muñoz R, Bambs C, Guzmán S, Ibáñez L, Gersin K (2012) Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal–jejunal bypass liner. Ann Surg 255:1080–1085

  23. 23.

    Montana R, Slako M, Escalona A (2012) Implantation of the duodenal–jejunal bypass sleeve under conscious sedation. SOARD 8:63–65

  24. 24.

    Neupanea N, Schmidtb MF, Gulatic N, Perwaizd M, Hammoudeha F, Kennedya E, Zahira M, Enriqueze D (2011) Pretracheal abscess following two weeks of endotracheal intubation. Yale J Biol Med 81:9–13

  25. 25.

    Björntorp P (1997) Obesity. Lancet 350:423–426

  26. 26.

    Ray C, Sue D, Bray G, Hansen JE, Wasserman K (1983) Effects of obesity on respiratory function. Am Rev Respir Dis 128:501–506

  27. 27.

    Jennum P, Sjol A (1992) Epidemiology of snoring and obstructive sleep apnoea in a Danish population age 30–60. J Sleep Res 1:240–244

  28. 28.

    Simonds SE, Cowley MA (2013) Hypertension in obesity: is leptin the culprit? Trends Neurosci 36(2):121–132

  29. 29.

    Mikhail N, Golub MS, Tuck ML (1999) Obesity and hypertension. Prog Cardiovasc Dis 42:39–58

  30. 30.

    Duflou J, Virmani R, Rabin I, Burke A, Farb A, Smialek J (1995) Sudden death as a result of heart disease in morbid obesity. Am Heart J 130:306–313

Download references

Acknowledgments

The authors would like to thank Ishaq Ghariq for drawing the illustration (Fig. 1).

Disclosures

Parviez Koehestanie, Ignace Janssen, and Peter Wahab have received consultant fees and support for travel as proctors from GI Dynamics. Bark Betzel, Kemal Dogan, Frits Berends, Edo Aarts, and Marcel Groenen have no conflicts of financial ties to disclose.

Author information

Correspondence to Parviez Koehestanie.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Koehestanie, P., Betzel, B., Dogan, K. et al. The feasibility of delivering a duodenal–jejunal bypass liner (endobarrier) endoscopically with patients under conscious sedation. Surg Endosc 28, 325–330 (2014). https://doi.org/10.1007/s00464-013-3143-9

Download citation

Keywords

  • Duodenal–jejunal bypass liner
  • Endobarrier
  • Type 2 diabetes mellitus
  • Conscious sedation