Evidence map›Paper›PMID 30877567›Full record

Observational studySurgical endoscopy2020

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation.

B Betzel, M I Cooiman, E O Aarts, I M C Janssen, P J Wahab, M J M Groenen, J P H Drenth, F J Berends

Abstract readObservational Study
In one paragraph

Observational study in Surgical endoscopy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Measures of glucose homeostasis during and after duodenal exclusion using a duodenal-jejunal bypass liner in a normoglycemic, nonobese canine model.Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery · 2022
    Article
  7. Review
  8. Article
  9. Bariatric and Metabolic Endoscopy: A New Paradigm.Clinical and translational gastroenterology · 2021
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

B BetzelDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, P.O. Box 9101, Code 455, 6500 HB, Nijmegen, The Netherlands. Bark.Betzel@radboudumc.nl.ORCID 0000-0003-0593-8375
M I CooimanVitalys Clinic, Velp, The Netherlands.
E O AartsVitalys Clinic, Velp, The Netherlands.
I M C JanssenVitalys Clinic, Velp, The Netherlands.
P J WahabDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.
M J M GroenenDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.
J P H DrenthDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, P.O. Box 9101, Code 455, 6500 HB, Nijmegen, The Netherlands.
F J BerendsVitalys Clinic, Velp, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsPatients 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.

resultsImplantation 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.

conclusionsDJBL 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.

Indexed as

Prostheses and ImplantsAdolescentAdultAgedBariatric SurgeryBiomarkersBlood GlucoseDevice RemovalDiabetes Mellitus, Type 2DuodenumFemaleFollow-Up StudiesGlycated HemoglobinHumansJejunumMaleBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanAdverse eventsDiabetes mellitusDuodenal-jejunal bypass linerEndobarrierHepatic abscessMigration

Identifiers

PMID30877567
PMCPMC6946747

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.