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Erschienen in: Surgical Endoscopy 11/2015

01.11.2015

One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity

verfasst von: Bryan J. Sandler, Roberto Rumbaut, C. Paul Swain, Gustavo Torres, Luis Morales, Lizcelly Gonzales, Sarah Schultz, Mark A. Talamini, Garth R. Jacobsen, Santiago Horgan

Erschienen in: Surgical Endoscopy | Ausgabe 11/2015

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Abstract

Introduction

Here, we report the first series of patients with 1-year implantation of a novel, endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities.

Methods and procedures

A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The GJBS is a 120-cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques that is designed to create an endoluminal gastro-duodeno-jejunal bypass. The device was implanted and, at the completion of the trial, retrieved with an endoscopic technique. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in comorbidities, specifically glucose control, use of antihyperglycemics, and changes in hemoglobin A1C levels.

Results

From July 2009 until October 2009, 13 patients were prospectively enrolled for the 1-year trial. The study included five men and eight women with a mean preoperative BMI of 42 kg/m2. One patient was excluded, at the time of endoscopic evaluation, due to inflammation at the GE junction. Two additional patients required early explantation of the device, within the first 4 weeks, due to patient intolerance. Upon explant of the device, both patients’ symptoms improved. In the remaining ten patients, the device was implanted, left in situ for 12 months, and then retrieved endoscopically. Safe delivery of the cuff at the gastro-esophageal junction was seen in all ten patients whom had device implants, without complication. No esophageal leak was seen immediately post-procedure or during follow-up. The sleeve device was well tolerated within the bowel lumen during the 12-month study, specifically, no bowel erosions, ulceration, or pancreatitis was observed. All ten patients reached the 1-year mark. Of the ten, six had fully attached and functional devices throughout the follow-up, verified by endoscopy. The mean percentage EWL, at 1 year, in this group was 54 %. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. The percentage EWL was lower in this group. Of the six patients that reached a year with a fully attached device, five were followed at an average of 14-months post-explant (26 months from the time of device implant). These five maintained an average percentage EWL of 30 % at the 14-month post-explant follow-up. Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of antihyperglycemics. Each of the measured comorbidities showed improvement during the 12-month trial.

Discussion

The endoluminal, GJBS can be safely placed and retrieved. The short-term data show it is well tolerated with a good safety profile. It achieves excellent weight loss results with over 70 % of all comorbidities resolved or significantly improved.
Literatur
1.
Zurück zum Zitat Freedman DS (2011) Obesity—United States, 1988–2008. MMWR Surveill Summ 60(Suppl):73–77PubMed Freedman DS (2011) Obesity—United States, 1988–2008. MMWR Surveill Summ 60(Suppl):73–77PubMed
2.
Zurück zum Zitat Wang YC, McPherson K, Marsh T, Gortmaker SL, Brown M (2011) Health and economic burden of the projected obesity trends in the USA and the UK. Lancet 378(9793):815–825CrossRefPubMed Wang YC, McPherson K, Marsh T, Gortmaker SL, Brown M (2011) Health and economic burden of the projected obesity trends in the USA and the UK. Lancet 378(9793):815–825CrossRefPubMed
3.
Zurück zum Zitat Padwal R, Li SK, Lau DC (2004) Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev 3:004094 Padwal R, Li SK, Lau DC (2004) Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev 3:004094
4.
5.
Zurück zum Zitat Ryou M, Ryan MB, Thompson CC (2011) Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointest Endosc Clin N Am 21(2):315–333PubMedCentralCrossRefPubMed Ryou M, Ryan MB, Thompson CC (2011) Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointest Endosc Clin N Am 21(2):315–333PubMedCentralCrossRefPubMed
6.
Zurück zum Zitat Brethauer SA, Chand B, Schauer PR, Thompson CC (2010) Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients. Surg Obes Relat Dis 6(6):689–694CrossRefPubMed Brethauer SA, Chand B, Schauer PR, Thompson CC (2010) Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients. Surg Obes Relat Dis 6(6):689–694CrossRefPubMed
7.
Zurück zum Zitat Horgan S, Jacobsen G, Weiss GD, Oldham JS Jr, Denk PM, Borao F, Gorcey S, Watkins B, Mobley J, Thompson K, Spivack A, Voellinger D, Thompson C, Swanstrom L, Shah P, Haber G, Brengman M, Schroder G (2010) Incisionless revision of post-Roux-en-Y bypass stomal and pouch dilation: multicenter registry results. Surg Obes Relat Dis 6(3):290–295CrossRefPubMed Horgan S, Jacobsen G, Weiss GD, Oldham JS Jr, Denk PM, Borao F, Gorcey S, Watkins B, Mobley J, Thompson K, Spivack A, Voellinger D, Thompson C, Swanstrom L, Shah P, Haber G, Brengman M, Schroder G (2010) Incisionless revision of post-Roux-en-Y bypass stomal and pouch dilation: multicenter registry results. Surg Obes Relat Dis 6(3):290–295CrossRefPubMed
8.
Zurück zum Zitat Schurr MO, Ho CN, Rieber F, Fleisch C, Coscarella G, Tognoni V, Di Lorenzo N (2009) Implantable endoscopic gastric bypass—device and experimental procedure. Minim Invasive Ther Allied Technol 18(5):273–279CrossRefPubMed Schurr MO, Ho CN, Rieber F, Fleisch C, Coscarella G, Tognoni V, Di Lorenzo N (2009) Implantable endoscopic gastric bypass—device and experimental procedure. Minim Invasive Ther Allied Technol 18(5):273–279CrossRefPubMed
9.
Zurück zum Zitat Tarnoff M, Shikora S, Lembo A (2008) Acute technical feasibility of an endoscopic duodenal-jejunal bypass sleeve in a porcine model: a potentially novel treatment for obesity and type 2 diabetes. Surg Endosc 22(3):772–776CrossRefPubMed Tarnoff M, Shikora S, Lembo A (2008) Acute technical feasibility of an endoscopic duodenal-jejunal bypass sleeve in a porcine model: a potentially novel treatment for obesity and type 2 diabetes. Surg Endosc 22(3):772–776CrossRefPubMed
10.
Zurück zum Zitat Sandler BJ, Rumbaut R, Paul Swain C, Torres G, Morales L, Gonzales L, Schultz S, Talamini M, Horgan S (2011) Human experience with an endoluminal, endoscopic, gastrojejunal bypass sleeve. Surg Endosc 25(9):3028–3033CrossRefPubMed Sandler BJ, Rumbaut R, Paul Swain C, Torres G, Morales L, Gonzales L, Schultz S, Talamini M, Horgan S (2011) Human experience with an endoluminal, endoscopic, gastrojejunal bypass sleeve. Surg Endosc 25(9):3028–3033CrossRefPubMed
11.
Zurück zum Zitat Gadde KM, Allison DB (2009) Combination therapy for obesity and metabolic disease. Curr Opin Endocrinol Diabetes Obes 16(5):353–358CrossRefPubMed Gadde KM, Allison DB (2009) Combination therapy for obesity and metabolic disease. Curr Opin Endocrinol Diabetes Obes 16(5):353–358CrossRefPubMed
12.
Zurück zum Zitat Bondada S, Jen HC, Deugart DA (2011) Outcomes of bariatric surgery in adolescents. Curr Opin Pediatr 23(5):552–556CrossRefPubMed Bondada S, Jen HC, Deugart DA (2011) Outcomes of bariatric surgery in adolescents. Curr Opin Pediatr 23(5):552–556CrossRefPubMed
Metadaten
Titel
One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity
verfasst von
Bryan J. Sandler
Roberto Rumbaut
C. Paul Swain
Gustavo Torres
Luis Morales
Lizcelly Gonzales
Sarah Schultz
Mark A. Talamini
Garth R. Jacobsen
Santiago Horgan
Publikationsdatum
01.11.2015
Verlag
Springer US
Erschienen in
Surgical Endoscopy / Ausgabe 11/2015
Print ISSN: 0930-2794
Elektronische ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-015-4081-5

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