Evidence map›Paper›PMID 38885635›Full record

Trial reportDigestion2024

Weight-Loss Endoscopy Trial: A Multicenter, Randomized, Controlled Trial Comparing Weight Loss in Endoscopically Implanted Duodenal-Jejunal Bypass Liners versus Intragastric Balloons versus a Sham Procedure.

Marcus Hollenbach, Jürgen Feisthammel, Christiane Prettin, Felix Gundling, Wolfgang Schepp, Jürgen Stein, David Petroff, Albrecht Hoffmeister

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestion, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Advances and future directions in endoscopic bariatric therapies.World journal of gastrointestinal endoscopy · 2025
    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.

Marcus HollenbachDivision of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany.
Jürgen FeisthammelDivision of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany.
Christiane PrettinClinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany.
Felix GundlingClinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Clinic, Munich, Germany.
Wolfgang ScheppClinic for Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Clinic, Munich, Germany.
Jürgen SteinClinic for Internal Medicine, Division of Gastroenterology, Sachsenhausen Clinic, Frankfurt, Germany.
David PetroffClinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany.
Albrecht HoffmeisterDivision of Gastroenterology, Medical Department II, University of Leipzig Medical Center, Leipzig, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionObesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far.

methodsWe performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications.

resultsThirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare.

conclusionEndoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.

Indexed as

DuodenumGastric BalloonJejunumQuality of LifeWeight LossAdultBariatric SurgeryBody Mass IndexDevice RemovalEndoscopy, GastrointestinalFemaleHumansMaleMiddle AgedObesityObesity, MorbidBypass linerDiabetesEndoscopyIntragastric balloonObesityWeight loss

Identifiers

PMID38885635
PMCPMC11633907

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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.