PMID- 28664427
OWN - NLM
STAT- MEDLINE
DCOM- 20190307
LR  - 20190307
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 32
IP  - 1
DP  - 2018 Jan
TI  - Safety and efficacy of the endoscopic duodenal-jejunal bypass liner prototype in 
      severe or morbidly obese subjects implanted for up to 3 years.
PG  - 260-267
LID - 10.1007/s00464-017-5672-0 [doi]
AB  - BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that 
      mimics the duodenal-jejunal exclusion component of the Roux-en-Y gastric bypass. 
      Previous studies assessing the efficacy of the DJBL have shown 10-40% excess 
      weight loss (%EWL) and improvements in obesity-associated comorbidities. The aim 
      of this study was to evaluate the safety and efficacy of a new DJBL prototype 
      over a 3-year period. METHODS: Morbidly obese subjects were enrolled in a 
      single-arm, open-label, prospective trial. The subjects were offered the 
      opportunity to continue with the trial annually and signed a new consent form. 
      The primary endpoint was safety. The secondary endpoints were changes in weight 
      and biochemical parameters from baseline. RESULTS: The DJBL was implanted 
      endoscopically in 80 subjects (age: 35+/-10 years; 69% female; weight: 109+/-17 kg; 
      BMI: 42+/-5.4 kg/m(2)). Seventy-two severe adverse events (AEs) were observed in 55 
      patients (68%), of which nine subjects required a prolonged hospital stay and 
      three subjects required major interventions. Overall, 23 subjects (29%) underwent 
      early device removal due to AEs. Additionally, 95% of the patients experienced 
      mild AEs that mainly consisted of abdominal pain. The severe AEs included a liver 
      abscess (3), upper GI bleeding (4), cholangitis (1), and acute pancreatitis (1) 
      and mostly occurred after 12 months of follow-up. Two patients presented a short 
      esophageal perforation during explantation. These perforations were successfully 
      managed with endoscopic closure in one subject and medical treatment in the other 
      subject. In the completer population at 52 weeks (71 patients), 104 weeks (40 
      patients), and 156 weeks (11 patients), the mean %EWL were 44 +/- 16, 40 +/- 22, and 
      39 +/- 20, respectively (p < 0.001). CONCLUSION: This study shows significant and 
      sustained weight loss after 3 years of treatment with the new DJBL. However, the 
      high frequency and severity of AEs preclude the use of this prototype for periods 
      longer than 1 year.
FAU - Quezada, Nicolas
AU  - Quezada N
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile. 
      nfquezada@gmail.com.
FAU - Munoz, Rodrigo
AU  - Munoz R
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile.
FAU - Morelli, Carla
AU  - Morelli C
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile.
FAU - Turiel, Dannae
AU  - Turiel D
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile.
FAU - Hernandez, Julian
AU  - Hernandez J
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile.
FAU - Pimentel, Fernando
AU  - Pimentel F
AD  - Department of Digestive Surgery, School of Medicine Pontificia Universidad 
      Catolica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile.
FAU - Escalona, Alex
AU  - Escalona A
AD  - Universidad de los Andes, Santiago, Chile.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20170629
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Bariatric Surgery/*instrumentation/methods
MH  - *Endoscopy, Gastrointestinal
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Obesity, Morbid/*surgery
MH  - Postoperative Complications/epidemiology
MH  - Prospective Studies
MH  - *Prostheses and Implants/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Weight Loss
MH  - Young Adult
OTO - NOTNLM
OT  - Bariatric
OT  - Endobarrier
OT  - Endoscopy
OT  - Obesity
EDAT- 2017/07/01 06:00
MHDA- 2019/03/08 06:00
CRDT- 2017/07/01 06:00
PHST- 2016/05/16 00:00 [received]
PHST- 2017/06/13 00:00 [accepted]
PHST- 2017/07/01 06:00 [pubmed]
PHST- 2019/03/08 06:00 [medline]
PHST- 2017/07/01 06:00 [entrez]
AID - 10.1007/s00464-017-5672-0 [pii]
AID - 10.1007/s00464-017-5672-0 [doi]
PST - ppublish
SO  - Surg Endosc. 2018 Jan;32(1):260-267. doi: 10.1007/s00464-017-5672-0. Epub 2017 
      Jun 29.