PMID- 30877567
OWN - NLM
STAT- MEDLINE
DCOM- 20201008
LR  - 20221207
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Print)
IS  - 0930-2794 (Linking)
VI  - 34
IP  - 1
DP  - 2020 Jan
TI  - Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 
      months of duodenal-jejunal bypass liner implantation.
PG  - 209-215
LID - 10.1007/s00464-019-06752-8 [doi]
AB  - BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device 
      designed to induce weight loss and improve glycemic control. The liner is 
      licensed for a maximum implant duration of 12 months. It might be hypothesized 
      that extension of the dwelling time results in added value. The goals of our 
      study were to determine weight change, change in glycemic control, and safety in 
      patients with an intended 24 months of DJBL dwelling time. METHODS: Patients were 
      initially selected for a 12-month implantation period. When no physical 
      complaints or adverse events (AEs) occurred, motivated patients who responded 
      well were selected for extension of dwelling time to 24 months. Patients 
      underwent a control endoscopy 12 months after implantation and visited the 
      out-patient clinic every 3 months up to explantation. Patients agreed to remove 
      the DJBL when complaints or AEs occurred that could not be treated 
      conservatively. RESULTS: Implantation was extended in 44 patients, and 24 (55%) 
      patients completed the full 24 months. Twenty patients required early removal due 
      to AEs. During dwelling time, body weight decreased significantly (15.9 kg; TBWL 
      14.6%). HbA1c decreased non-significantly (4.9 mmol/mol). The number of insulin 
      users and daily dose of insulin both decreased significantly. At 24 months after 
      removal, glycemic control had worsened, while body weight was still significantly 
      lower compared to baseline. In total, 68% of the patients experienced at least 
      one AE. Two patients developed a hepatic abscess. CONCLUSIONS: DJBL treatment 
      results in significant weight loss and improves glycemic control during 
      implantation. The largest beneficial effects occur during the first 9-12 months 
      after implantation. Extension of dwelling time to 24 months results only in 
      stabilization of body weight and glycemic control. After explantation, weight 
      improvements are maintained, but glycemic control worsens. As the cumulative risk 
      of AEs increases with time, a maximal dwelling time of 12 months is advisable.
FAU - Betzel, B
AU  - Betzel B
AUID- ORCID: 0000-0003-0593-8375
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      P.O. Box 9101, Code 455, 6500 HB, Nijmegen, The Netherlands. 
      Bark.Betzel@radboudumc.nl.
FAU - Cooiman, M I
AU  - Cooiman MI
AD  - Vitalys Clinic, Velp, The Netherlands.
AD  - Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
FAU - Aarts, E O
AU  - Aarts EO
AD  - Vitalys Clinic, Velp, The Netherlands.
AD  - Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
FAU - Janssen, I M C
AU  - Janssen IMC
AD  - Vitalys Clinic, Velp, The Netherlands.
AD  - Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
FAU - Wahab, P J
AU  - Wahab PJ
AD  - Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The 
      Netherlands.
FAU - Groenen, M J M
AU  - Groenen MJM
AD  - Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The 
      Netherlands.
FAU - Drenth, J P H
AU  - Drenth JPH
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      P.O. Box 9101, Code 455, 6500 HB, Nijmegen, The Netherlands.
FAU - Berends, F J
AU  - Berends FJ
AD  - Vitalys Clinic, Velp, The Netherlands.
AD  - Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20190314
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Bariatric Surgery/instrumentation/*methods
MH  - Biomarkers/blood
MH  - Blood Glucose/metabolism
MH  - Device Removal
MH  - Diabetes Mellitus, Type 2/blood/complications/*surgery
MH  - Duodenum/*surgery
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Jejunum/*surgery
MH  - Male
MH  - Middle Aged
MH  - Obesity/blood/complications/*surgery
MH  - Patient Safety
MH  - Postoperative Complications/epidemiology/therapy
MH  - Prospective Studies
MH  - *Prostheses and Implants/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Weight Loss
MH  - Young Adult
PMC - PMC6946747
OTO - NOTNLM
OT  - Adverse events
OT  - Diabetes mellitus
OT  - Duodenal-jejunal bypass liner
OT  - Endobarrier
OT  - Hepatic abscess
OT  - Migration
COIS- Dr. E.O. Aarts, and dr. P.J. Wahab received support for travel as proctor from GI 
      Dynamics. Drs. Janssen received financial research support and consultancy fees 
      from GI Dynamics. Drs. B. Betzel, drs. M. Cooiman, dr. M.J.M. Groenen, dr. J.P.H. 
      Drenth, and dr. F.J. Berends have no conflicts of interests of financial ties to 
      disclose.
EDAT- 2019/03/17 06:00
MHDA- 2020/10/09 06:00
PMCR- 2019/03/14
CRDT- 2019/03/17 06:00
PHST- 2018/08/27 00:00 [received]
PHST- 2019/03/06 00:00 [accepted]
PHST- 2019/03/17 06:00 [pubmed]
PHST- 2020/10/09 06:00 [medline]
PHST- 2019/03/17 06:00 [entrez]
PHST- 2019/03/14 00:00 [pmc-release]
AID - 10.1007/s00464-019-06752-8 [pii]
AID - 6752 [pii]
AID - 10.1007/s00464-019-06752-8 [doi]
PST - ppublish
SO  - Surg Endosc. 2020 Jan;34(1):209-215. doi: 10.1007/s00464-019-06752-8. Epub 2019 
      Mar 14.